STARchy Staples: a Randomised Controlled Trial on Cardiometabolic Health
Phase: NA
Conditions: Cardiometabolic Health
Sponsor: King's College London

 
 
 
 
 
STARCHy staples: a randomised 
controlled trial on Cardiometabolic 
Health. 
 
Clinical Trials ref: NCT05994313 
 
REC: HR/DP-22/23-35587 
 
Version number: 5.1 
 31 August 2025 
 
Short title/ Acronym: The STARCHy study. 
 
 
 
 
 
 
 
 
 
 

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Abbreviations 
CGM - Continuous Glucose Monitor 
ECG – Electrocardiogram 
HRV – Heart Rate Variability 
BP- Blood pressure 
FMD – Flow mediated dilation 
VAS – Visual analogue scale 
 
1. Trial summary 
Responsible Individuals  
Principal Investigators  
Professor Wendy Hall 
Reader in Nutritional Sciences 
Franklin Wilkins Building 
Faculty of Life Sciences and Medicine 
Department of Nutritional Sciences 
150 Stamford Street, London, SE1 9NH 
Email: wendy.hall.ac.uk 
 
Professor Sarah Berry 
Reader in Nutritional Sciences 
Franklin Wilkins Building 
Faculty of Life Sciences and Medicine 
Department of Nutritional Sciences 
150 Stamford Street, London, SE1 9NH 
Email: sarah.e.berry@kcl.ac.uk 
 
PhD researcher and trial coordinator 
Anya Klarner, ANutr 
Franklin Wilkins Building, Room 4.46 
Faculty of Life Sciences and Medicine 
Department of Nutritional Sciences 
150 Stamford Street, London, SE1 9NH 
Email: anya.klarner@kcl.ac.uk 
 
 
Collaborators 
Dr Peter Joris 
Universiteitssingel 50, room 0.314 
P.O. Box 616, 6200 MD Maastricht, The Netherlands 
Phone: +31 (0)43 388 1311 
E-mail: p.joris@maastrichtuniversity.nl 

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Nihat Baysal 
Chemical and Biological Engineering 
Rensselaer Polytechnic Institute, Troy, New York 12180-3590 
E-mail: baysan@rpi.edu 
 
 
Study Synopsis 
Title  
STARCHy staples: a randomised controlled trial on 
Cardiometabolic Health  
Protocol Short Title/Acronym 
The STARCHy study 
 
Protocol Version number and Date Version 5: 20/08/2025 
Study Phase if not mentioned in 
title 
n/a 
Is the study a Pilot? 
No 
 
Study Site 
In-person visits: Metabolic Research Unit, Corridor A, 4th floor, 
Franklin Wilkins Building, SE1 9NH 
Remote video calls via Teams  
Study Duration 
24-months 
 
Official study start date 
09/09/2023 
Estimated Primary Completion 
01/05/2025 
Methodology 
 
A randomised, two-parallel arm, in clinic and remote, 12-week 
dietary intervention, with a 2-week run in period.  
 
Participants with either receive 230g of potatoes in their evening 
meal (intervention) or isocaloric amounts of other refined starchy 
staples, such as rice, pasta, or cous cous (control).  
 
Participants will make their own meals based on dietary guidance 
and resources (meal plans), given from a registered nutritionist, to 
match UK recommendations.  
 
   
 
Sponsor name 
King’s College London 

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Chief Investigator 
Dr Wendy Hall and Dr Sarah Berry 
 
REC number 
22/23-35587 
 
Medical condition or disease 
under investigation 
Cardio-metabolic health  
 
Purpose of clinical trial 
To investigate the cardio-metabolic health effects of consuming 
potatoes in place of other refined carbohydrate (pasta and rice), 
in healthy adults. 
 
Primary objective 
The primary objective of this proposal is to investigate whether 
consuming a portion of potatoes in the evening meal, in place of 
other refined carbohydrates, can improve sleep quality 
(measurable as the ratio of total sleep time in bed: “sleep 
efficiency”), and improve mean nocturnal glucose, both risk 
factors for cardiometabolic diseases.  
 
Secondary objective (s) 
To investigate the effects of regular white potato consumption on 
endothelium-dependent vasodilation (measured by flow-
mediated dilatation) and other related biomarkers of cardio-
metabolic disease risk, when compared to regular refined 
carbohydrate consumption. 
 
Number of Participants 
The study aims to recruit a total of 80 participants (allowing ~15% 
drop out rate), for an allocation of 1:1 intervention to control, to 
reach 80% power at a significance level of 0.025 (based on two 
outcomes).  
Trial Design  
A randomised, two-parallel arm, in clinic and remote, 12-week 
dietary intervention study. 
Study arms 
1. Experimental: Habitual potato consumption.  
At minimum of 230g white potatoes, including fresh and frozen, 
baked, boiled and mashed potatoes, will be consumed in the 
evening meal, in replacement of other starches. 
2. Active Comparator: Habitual non-nutrient dense starch 
consumption. 

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Isocaloric amount of non-nutrient dense starchy staples, such as 
white rice, white pasta, and white couscous, will be consume din 
the evening meal. 
Endpoints 
Primary 
• 
7-day Sleep efficiency, at baseline and endline  
• 
12-day nocturnal mean glucose (using Continuous 
Glucose Monitors (CGM) during sleep), at baseline (0 
weeks) and endline (12 weeks) 
Secondary 
• 
Endothelium-dependent vasodilation (measured by 
ultrasound image analysis as Flow-Mediated Dilation 
(FMD)), at baseline and endline. 
• 
12-day daytime and 24-hour glucose metabolism (CGM 
outcomes, glycaemic variability, time in range).  
• 
48hrs nocturnal, daytime and stress-related heart rate 
variability (measure of autonomic function; higher range 
the more autonomic function) 
• 
12-week daytime and night-time continuous blood 
pressure (Aktiia blood pressure bracelet) 
• 
Blood parameters 
o Glucose control (fasting HbA1C, fasting glucose 
and insulin) 
o Lipids 
• 
Body composition 
o weight and waist circumference 
o % body fat and lean body mass (Tanita scales) 
• 
Visual Analogue Scale (VAS) assessments of satiety, 
included in 4-day diet diaries. 
• 
Urinary potassium and sodium 
• 
Urinary alkaloids (calystegines) 
Compliance 
• 
Urinary potassium and sodium 
• 
Dietary assessments 
o 24-hour recall (Wk 2, 4, 8) 
o 4-day food diary (Wk 0, 6, 12) 
o Self-reported adherence: checklist of evening 
meal  
Main Inclusion Criteria 
Participants will be healthy male or females, aged between 40-80 
years who consume ≤4 fruits and vegetables a day (excluding 
potatoes), with a less favourable sleep efficiency score of <85%  

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Statistical Methodology and 
Analysis 
Differences between groups (minimized for age, gender, BMI) will 
be analysed using Linear mixed models for outcomes with 3 
timepoints (urinary outcomes, dietary intake data), with change 
being the dependent factor, participant ID as random effect, 
treatment and season as fixed effects, and baseline outcome and 
BMI as covariates. Variables with 2 timepoints will be assessed with 
an ANCOVA regression model. 
 
A 2 -sided P value <0.05 will be considered as showing statistical 
significance.  
 
For more details of statistical analysis plan, see section 4.2. 
 
Data monitoring and sharing 
No formal data monitoring committee. Oversight by PI and 
sponsor. 
 
De-identified data will be shared upon reasonable request and in 
collaboration with the study investigators, beginning 12 months 
after publication of the main trial results. 
2. Introduction 
2.1 Background 
There are several studies currently underway to explore the CM health effects of diets rich in potatoes 
on glucose metabolism, lipids, inflammation, and blood pressure/vascular function. However, to our 
knowledge, none investigate the potentially favourable impact of potatoes on the harmful triad of poor 
sleep - adverse glycaemic control - vascular dysfunction.   
Poor sleep quality is related to adverse glycaemic control: can increasing potassium intake help? 
The deleterious impact of poor sleep on diet, obesity and CM health (1) has been consistently reported 
in observational and interventional studies (2). Potential mediating mechanisms include; impaired 
endothelial function (3), perturbed postprandial (4) and nocturnal glycaemic responses (5), raised blood 
pressure, and bi-directional associations between diet and poor sleep quality (6).  Results from the 
PREDICT 1 cohort (n=1102) showed that participants with higher sleep efficiency (i.e. better sleep 
quality), measured objectively using wrist actigraphy, had lower postprandial blood glucose the next 
day following a standardised test meal than those with low sleep efficiency, and this relationship was 
replicated upon within-participant analysis, suggesting that better sleep quality could lead to improved 
glycaemic control in healthy individuals (4). This potential causal link between poor sleep quality and 
adverse glycaemic control may be mediated via poor diet quality in free-living conditions, as inadequate 
sleep increases cravings for less healthy foods (7) (and vice versa, poor dietary choices may impact on 
sleep quality (6)). However, there may also be a direct effect by increasing sympathetic outflow thereby 
suppressing insulin secretory responses to fluctuations in glucose (8). 
High dietary glycaemic index (GI) is associated with greater subsequent risk of insomnia (9) whereas 
higher intakes of fruit, fibre and vegetables (9, 10, 11) are associated with better sleep quality. The 
effects of fruits and vegetables on sleep quality have been suggested to be related to their polyphenol, 
melatonin, and serotonin contents (6), but little attention has been paid to their potassium content as 
a putative sleep quality promoter.  Preliminary data analysis using our PREDICT cohort show that there 
is a positive association between potassium intakes and sleep duration (P=0.02) and an inverse 

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association between fasting glucose and glycaemic variability with potassium intakes (P=0.03, P=0.04) 
respectively, adjusted for age, sex, BMI and energy intake. This requires further investigation as regards 
to the source of potassium and adjusting for background diet, as proposed in this application. Potassium 
may plausibly modify sleep quality (12), glycaemic control (via insulin secretion (13)) and cardiovascular 
function (14) by modifying autonomic function. For example, potassium supplementation in rats with 
chronic heart failure reduces sympathetic overactivity and restored baroreflex function (15) and 
reduces risk of CVD mortality (16) and reduces blood pressure in human studies (17, 18), the latter 
mediated in part by preservation of autonomic function (19), as well as reduction in renal sodium 
reabsorption and stimulation of endothelium-dependent vasodilation.  
Endothelial function: can increasing potassium help? 
Sufficient dietary potassium may improve sleep quality and glycaemic control, and consequently this 
may support better endothelial function. Poor sleep quality has been reported to be associated with 
lower FMD in a cohort of healthy adults (20) and restricting sleep by one-third causes endothelial 
dysfunction in healthy individuals (21). Likewise, oscillating blood glucose concentrations in healthy 
volunteers led to impaired endothelial function, likely to be mediated via vascular inflammation and 
oxidative stress (22). However, there is also evidence that potassium could directly act on the 
endothelium to increase nitric oxide production (and thus endothelial function) (14, 23), which could 
also potentially benefit autonomic function by enabling greater nitric oxide bioavailability in the brain 
as well as the blood vessels (24).  
 
Potassium intakes and potato consumption in the UK and US 
Low population dietary intake of potassium is a point of concern in both the UK (median intake 79% of 
the reference nutrient intake) and US. However, potatoes are the greatest contributors of dietary 
potassium for a single food (UK and US), contributing 14% of intakes in UK 19-64 y olds (consumers and 
non-consumers) (25) and 20% of intakes in US (for consumers) (26). Although regarded as a high 
glycaemic index food, potatoes that were boiled, roasted, or boiled then cooled, resulted in markedly 
lower nocturnal interstitial glucose concentrations compared to rice in individuals with type 2 diabetes 
despite there being no glycaemic differences in the acute postprandial period (27). Potatoes are rich in 
micronutrients, unlike commonly consumed starchy staples such as white rice and pasta. In addition to 
potassium, potatoes contribute 15% of vitamin B6 intake, 14% of vitamin C and 10% of folate in the UK 
(28), and therefore contain a range of components that may additively improve glucose metabolism, 
endothelial function and sleep quality beyond the immediate postprandial period.  
 
2.2 Hypothesis and rationale 
In the long term, a potato-rich diet could be an important strategy for reducing risk of CM diseases. This 
proposal aims to unravel an array of understudied CM health variables that may be beneficially affected 
by habitual consumption of nutrient-dense white potatoes. 
We hypothesise that regular consumption of potatoes in place of other less nutrient-dense starchy 
foods increases sleep efficiency, reduces nocturnal glycaemic variability, and improves endothelial 
function in middle-aged to older adults. 
To establish causality between potato consumption and these outcome measures, including 
mediating mechanisms, we plan to conduct a randomised, two-parallel arm-controlled trial in healthy 
adults between the ages of 40-80 years.  

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3.0 Study Objectives and Design 
3.1 Study Objectives  
 
To answer the following research questions: 
Primary Objectives and endpoints (for detailed summaries of the outcomes, see section 3.3) 
1) Does regular consumption of white potatoes increase sleep quality, measurable as the ratio of total 
sleep time to time in bed: “sleep efficiency (SE)”?  
 
 
2) Does regular consumption of white potatoes improve night-time glycaemic control compared with 
other, less nutrient dense starchy staples (white pasta, white rice etc.)?  
 
Secondary Objectives and endpoints 
 
3) Does regular consumption of white potatoes improve endothelial function? 
 
 
4) Does regular consumption of white potatoes improve autonomic function? 
 
 
5) Does regular consumption of white potatoes improve blood lipid profiles, and glucose control 
(fasting glucose, fasting insulin, glycated haemoglobin), when compared with other, less nutrient 
dense starchy staples? 
 
 
6) Does regular consumption of white potatoes improve blood pressure? 
 
 
 
3.2 Intervention overview 
 
Table 1. Summary of the Starchy Study’s arms and Interventions, as written on ClinicalTrials.Gov 
 
Dietary Intervention 
The intervention (potato group) will consume 230 g white potatoes as one of their 5-a-day fruits and 
vegetables, providing ~1000 mg potassium (enough to increase national median intakes up to 

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recommended intakes) in their evening meal (25% of energy intake from carbohydrates, or 12.5% of 
total energy intake, including fresh and frozen baked, boiled, mashed potato products), whereas the 
control group will consume isoenergetic amounts of non-nutrient dense starchy staples (white pasta, 
white rice, or couscous).  
Participants will be given £5 per week, in renumeration for the purchasing of the starchy component. 
Although participants cannot be blinded to what they’re consuming, they will be blinded to whether 
they are in the control or the intervention group, to reduce risks of bias.  
We have chosen not to adjust for % estimated energy requirements as potatoes are typically eaten as 
a standard portion size (e.g., standard baked potato is ~200g), and this simplifies the intervention for 
the participant.  
Participants will be required to source the potatoes and make these meals themselves, however, they 
will be provided with rotating 4-weekly recipe cards, with instructions on how to prepare meals. 
Guidance on eating out will be provided to maintain study compliance, as successfully utilized in other 
studies (29). We believe this will sufficiently standardise nutrient intakes from the non-starchy staple 
dietary components both inter and intra arms. We plan to use the dietary recalls at weeks 2, 4 and 8 to 
reinforce dietary advice, and to make adaptations to rotating menus based on individual needs, if 
participants are struggling with adherence (30).  
Recipes will be generated by modelling meals in Nutritics software and will aim to follow food based 
dietary guidelines for the UK (31) and the US (32).  
Printed leaflets and dietetic/nutrition led coaching will be used to advise individuals on how to 
incorporate potatoes into their evening meal (to be eaten before 8pm) to ensure that the diet contains 
a mixed composition of potato categories, with consideration for habitual dietary intakes, as used in 
our previous dietary intervention studies (26,40). The study duration of 12 weeks has been selected as 
sufficient time to induce changes in fasting FMD (41), and glycaemic control (42). A parallel arm has 
been chosen to maintain compliance due to the duration of the intervention.  
Dietary Advice (Week 2 dietary consultation).  
Both arms will receive food-based dietary advice from an associate nutritionist, broadly consistent with 
UK dietary guidelines and USDA recommendations.  
These recommendations will be inclusive of, but not limited to: 
- 
Discourage snacking before bed and encourage food consumption before 8pm, to prevent 
unfavourable postprandial glycaemic responses as observed in clinical trials (33), and other 
metabolic dysfunction biomarkers (34), explained by chrono-nutrition (35). Although 
individuals tend to consume dinner later than at usual at the weekend (36), most of the UK 
and US population eat between 18:00-20:00 (37, 38), therefore we believe this is a feasible 
ask.  
- 
Reduce excessive alcohol intake or excessive changes in exercise habits. 
- 
To consume similar levels of salt, types of fat, and added sugars, to standardise across arms.  
- 
Additionally, participants will receive personalised advice on front of package labelling, 
eating out and choosing convenience meals. 
Compliance 
Biochemical Assessment 

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Compliance will be monitored by 24 h urinary potassium excretion, which is shown to recover 75% of 
potassium intake (39). These samples will be analysed by flame photometry (40). No other appropriate 
biomarkers of compliance are specific enough to monitor differences in the control and potato 
interventions in this study design. Additionally, sodium excretion will be analysed to indicate dietary 
sodium intake. This is a relevant indicator in our study as sodium intake could confound the results of 
this study. 
Urinary creatinine will be used as one marker to distinguish between complete and incomplete 24 h 
urine collections (41), specifically the Knuiman et al creatinine excretion method (urinary creatinine 
[mmol/d] x 113)/(21 x body weight [kg]) (42), which has been shown to be the most sensitive and 
specific (43). Samples with a creatinine index <0.7 will be discarded as incomplete.  
 
Additionally, self-reported missing samples (more than a few drops, as assessed by word of mouth and 
urine collection forms) and samples with a total volume <400 mL will marked as incomplete, as outlined 
in the NHANES survey (44).  
 
Midline urine samples will be analysed within a week of collection, to assess compliance.  
Dietary Assessment 
Dietary assessment evaluations will be built into the study design to evaluate and encourage 
compliance to treatments, including 4-d food records (WK 0, 6, 12), and 24h dietary recalls (WK 2, 4, 8) 
with the multipass method (45). 
Additionally, self-reported compliance methods will be employed via an evening meal checklist in the 
data diaries provided to participants. This will determine the level of compliance (%) and may be used 
as stratum in analysis. ≥75% of overall days exposed to the starch, as well as 75% of the days exposed 
in the final four weeks, will be counted as compliant. Any rates below 75% in either of these time 
periods, will be counted as non-compliant for ITT.  
 
3.3 Outcome variables 
Primary Outcomes 
Sleep efficiency: As aforementioned, increased dietary potassium may plausibly modify sleep quality, as 
previously seen in an interventional study by Drennan et al (46),  through mediation of improvements 
to autonomic function (19) and improved vascular function by restoring baroreflex function (15) and 
improving endothelium-dependent vasodilation (47).  
 
This is measured by using 7-d wrist actigraphy (MotionWatch8, CamNTech Ltd, Cambridge, UK) 
according to previously published procedures (7). Sleep quality (%) is measured as the amount of time 
spent asleep/ total amount of time spent in bed.  
12-day mean nocturnal glucose: Potatoes may improve nocturnal glucose through several pathways, 
involving increased dietary quality (48), such as increased vitamin C (49), increased dietary potassium 
(50) and increased satiety, when compared to alternative starches (51).  
Nocturnal measures were chosen to assess glycaemic regulation without the confounding influence of 
food intake. Whole sleep-time glycaemia parameters will be analysed is, and further sub analysis will 

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be done pre- and post-sleep, and mid-point to investigate potential differences according to sleep 
stages. 
CGM (Abbott Freestyle Libre 3) will be used to measure glycaemic control for 12 consecutive days. The 
principal investigators have recently reported on the high precision of the Abbott CGM (52). Twelve 
days has been selected as the 1st and last day of the CGM period may give unreliable results, therefore 
day 1 and 14 will be excluded from the analysis.  
 
Secondary outcomes 
Other nocturnal glucose markers: We will further analyse 12-day nocturnal area under the curve, 
glycaemic variability (GV), time in range non-diabetic population (TIRND). GV reflecting glucose 
fluctuations, are more strongly associated with oxidative stress than prolonged elevated glucose and 
glucose nadir and peaks, including the number and size (% change from pre-meal baseline) due to the 
association of glucose nadirs with hunger, satiety, alertness and energy intake (at subsequent meals 
and over 24 h period) (53) and peaks with oxidative stress and impairment in glycaemic control. 
Increased TIRND  is associated with improved cardiometabolic markers (lower HbA1c, HOMA-IR, and 10-
y ASCVD risk) and with poorer glucose tolerance when TIR is low (higher 1- and 2-h OGTT glucose) (54).  
Daytime glycaemic control: Additionally, we plan to look at the same markers across 12-day 
daytime and 24-hour period.  
Endothelial function: Impaired nitric oxide (NO) production causes endothelial dysfunction and 
increases risk of CVD (55). Capacity to synthesize NO can be assessed by ultrasound imaging of brachial 
arterial diameter before and after hyperaemia to determine FMD, regarded as the most reliable in vivo 
index (56). Measurements (and blood samples) will be taken at the same approximate time of day to 
account for circadian fluctuations, and by the same operator to reduce measurement error. All videos 
will be analysed using a custom MATLAB program (VidArt V13.5, A.P. Hoeks, Department of Biomedical 
Engineering, Maastricht University Medical Center (MUMC)+, Maastricht, The Netherlands) 
Heart rate variability (HRV) and blood pressure (BP): Improved HRV, a parameter of cardiac autonomic 
function, and BP are plausible health benefits of white potato consumption due to increased potassium 
intakes. Previous intervention studies have reported an improvement in clinic BP following potato 
consumption (18); however, the effects of potato intake on HRV have not been investigated to our 
knowledge. HRV is an indirect measure of autonomic nervous system function and predictive of risk of 
sudden cardiac death (57).  
HRV will be measured using a small wireless heart rate/ECG monitor that continuously records interbeat 
intervals (eMotion Faros 180, Mega Electronics Ltd) to calculate 48-h, daytime and night-time 
parameters using Cardiscope Analytics software (HASIBA Medical GmbH)  (58) Building on prior HRV 
analysis expertise (58, 59, 60), this will provide novel data on a hitherto unexplored risk factor for 
hypertension, T2D, chronic kidney disease and CVD events  in relation to potato consumption, and will 
provide important mechanistic information underpinning the 3 primary outcomes. BP will be measured 
at home using optical blood pressure monitoring via a bracelet. 2-hour averages will be obtained 
continuously for 12-weeks.  
Diet quality will be measured using dietary indices associated with health including PDI (61) (uPDI, hPDI), 
aMED (62), aHEI (62) and HFD (63, 64) to demonstrate the impact of potatoes on overall diet quality 
and for inclusion as a covariate in analysis.  

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Body composition: Weight will be measured (weekly) using home weighing scales. Percentage body fat 
will be assessed (baseline & endline) using bio-electrical impedance, and waist circumference will be 
measured with a tape measure at clinic visits. 
Blood biomarkers: Plasma lipids (total, HDL-, and LDL-cholesterol and TAG, and calculated TC:HDL-C 
ratio) will serve as clinically relevant biomarkers of metabolic dysregulation alongside fasting plasma 
glucose, insulin and HbA1c. Urine and serum potassium will be used to assess compliance as well as a 
potential stratifier in the analysis of outcomes. 
Urinary calystegine biomarker: Calystgeines will be analysed as an exploratory biomarker of potato 
consumption (a polyhydroxylated nortropane alkaloid) (65) by Triple Quadrupole mass spectrometry 
(MS/MS). This will accompany existing self-reported compliance records and increase the reliability of 
this outcome. To our knowledge, this will be the first time this biomarker has been used in a clinical 
trial setting.  
 
3.4 Study Design & Flowchart 
Overall study flow diagram is described in Figure 4, and a more detailed event and outcome matrix is 
summarised in Table 1.  
 
3.5 Population description.  
Participants will be aged 40-80 years old. As cardiometabolic health declines with age, this age group 
is typical of an at-risk population for cardiometabolic health disorders. This declination of health also 
offers more room to observe intervention improvements when compared to a younger population.  
The ethnicity will be reflective of the of the central London location of KCL. Previously, large dietary 
intervention trials conducted by the principal investigators, such as: MARINA, RISCK, DRFRUITNVEG 
and CRESSIDA, have recruited 66-85 % white, 9-10 % South Asian, 5-10 % Black African/Caribbean, 
and 2-4 % other ethnic groups (30, 39, 66). 
Participants will have less favourable self-reported sleep quality scores (<85%) (67), as assessed at 
screening. This sleep efficiency score has been chosen to allow more scope to detect intervention-
lead improvements.  
Participants will also consume <4 fruits and vegetables/day, as assessed at screening, which is 
representative of the typical UK/US diet (25).  
3.6 Recruitment methods 
Volunteers will be recruited from the public using Kings College emails (circular) and using social 
media adverts (Twitter, Facebook and Instagram). These methods successfully recruited 164 
participants in the CRESSIDA trial (30).  
Previous trial participants from the Department of Nutritional Science, who have consented to be 
contacted, will be emailed.  
Lastly, other institutions/universities, with publicly available contact addresses, may be emailed and 
asked to advertise our study via email and/or poster advertisement. 

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Drop-outs will be monitored in cohort 1 to assess recruitment targets. We have estimated that 
recruitment should roughly span one year from the study start.  
3.7 Sample screening 
Participants will be screened remotely with the use of questionnaires, to match them against the 
inclusion/exclusion criteria. At baseline clinic, participants BMI will be calculated via calibrated 
equipment to ensure they’re within range. They will also have a finger prick test to measure their 
fasting glucose, to screen participants for hyperglycaemia (>7mmol). If participants have 
hyperglycaemia, they will be excluded from the study and be referred to their GP for further tests.  
Email exchange: Upon showing interest in the advertisement, participants will be sent a Participant 
Information Sheet (PIS) along with an online screening questionnaire (using Qualtrics software) which 
matches participants against the inclusion/exclusion criteria).  
Introductory call: All eligible participants will receive a telephone/video call with a member of the 
study team, both to introduce themselves and the study. This call will serve as an opportunity for 
participants to ask questions, and to have their understanding of the study checked prior to giving 
consent. This call also allows the study team to build rapport with participants.  After this call, a 
consent form (Qualtrics software), will be emailed out.  
Once consent is remotely obtained, participants will be invited to a virtual 1:1 run-in induction.  
An overview of the flow from advertisement to identifying an eligible population, is summarised in 
Figure 5.  
3.8 Inclusion and exclusion criteria  
 
- 
Inclusion criteria 
- 
Healthy adults 
- 
Aged 40-80 years old 
- 
Intake of ≤4 portions of fruits and vegetables (excluding potatoes) per day 
- 
Low sleep quality- <85% sleep efficiency score on the PSQI 
- 
  
- 
Exclusion criteria 
- 
Shift workers and those with multiple jobs or carers who are required to wake through the night 
- 
Unwilling to refrain from dietary supplements 
- 
Unwilling to follow protocol and/or give informed consent 
- 
Diagnosed with Cardiovascular Disease (CVD), Type 2 Diabetes, Celiac disease, Insomnia, Sleep apnoea 
- 
Presence of gastrointestinal disorder 
- 
Users of drugs that are likely to alter gastrointestinal motility or nutrient absorption 
- 
History of substance abuse or alcoholism 
- 
Currently pregnant, planning pregnancy, breastfeeding or having had a baby 12-month prior 
- 
Weight change of >3kg in preceding 2-months 
- 
BMI <18.5kg/m2 or > 35kg/m2, 
- 
Current smokers, or individuals who quit smoking in the last 6-months 
- 
Frequently consume wholemeal products (1-2 times per day, in the short screening FFQ) 
- 
Never consumed refined starchy staple, such as white pasta or rice (rarely or never, in the short 
screening FFQ) 
- 
High potato consumption (4-6 times per week, in the short screening FFQ) 
- 
High risk of obstructive sleep apnoea (answer yes to >3 questions, in STOP-Bang questionnaire) 

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- 
Vegan 
- 
Sleep-related medications, or medications that may interfere with sleep 
- 
Fasting glucose >7mmol/l (finger prick test at baseline clinic) 

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Table 2. Event and Outcome matrix 
 
Time point 
Event 
Responsible party for 
taking measurement 
Relevant outcome 
Remote 
screening 
Intro call 
Run-in 
induction 
Run-in 
Baseline 
Clinic 
Wk 2 
WK 4 
WK 6 
WK 8 
Wk 10 
Endline 
Clinic (Wk 
12) 
Every day 
Every 
week 
Screening/prior to study 
Eligibility questionnaire 
incl Pittsburgh index and 
STOP-Bang questionnaire. 
Researcher 
Eligibility 
✔ 
 
 
 
 
 
 
 
 
 
 
 
 
Consent 
Researcher 
GCP 
 
✔ 
 
 
 
 
 
 
 
 
 
 
 
Posting equipment to 
participants 
Researcher 
Nocturnal glycaemia and sleep 
efficiency 
 
 
✔ 
 
 
 
 
 
 
✔ 
 
 
 
Virtual Run-in induction 
Researcher 
To discuss study equipment 
 
 
✔ 
 
 
 
 
 
 
 
 
 
 
Finger prick blood test 
Researcher 
Indication of hyperglycaemia 
(eligibility criteria) 
 
 
 
 
✔ 
 
 
 
 
 
 
 
 
Outcome related indicators 
CGM 
Participant 
Primary outcome 
 
 
 
✔ 
 
 
 
 
 
✔ 
 
 
 
Motion Watch 
Participant 
Primary outcome 
 
 
 
✔ 
 
 
 
 
 
✔ 
 
 
 
Fasted bloods 
Researcher 
 
Clinically relevant biomarkers 
of metabolic dysregulation 
 
Plasma lipids 
Plasma glucose 
HbA1C 
Insulin 
 
 
 
 
 
✔ 
 
 
 
 
 
✔ 
 
 
Adherence 
 
Serum potassium 
 
 
 
 
✔ 
 
 
 
 
 
✔ 
 
 
FMD 
Researcher 
Indicator of cardiometabolic 
health 
 
% change in arterial flow-
mediated dilation 
 
 
 
 
✔ 
 
 
 
 
 
✔ 
 
 

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Body composition (Tanita 
scales) 
Researcher 
Secondary outcome 
 
 
 
 
✔ 
 
 
 
 
 
✔ 
 
 
HRV (48-hours and acute 
response to stress) 
Researcher 
Secondary outcome 
 
 
 
 
✔ 
 
 
 
 
 
✔ 
 
 
Weight 
Participant 
Secondary outcome 
 
 
 
 
 
 
 
 
 
 
 
 
✔ 
Blood pressure 
(Automated via bracelet) 
Secondary outcome 
 
 
 
 
 
 
 
 
 
 
 
✔ 
 
4-day food diary + appetite 
visual analogue scale 
 
Participant 
Baseline and Endline: 24-
hr before clinics 
 
Midline: taken at home 
and sample posted 
 
 
Dietary data for quality 
indices/covariates 
 
PDI (uPDI,hPDI) 
aMED 
aHEI 
HFD  
 
 
 
 
 
✔ 
 
 
✔ 
 
 
✔ 
 
 
Compliance indicators 
Telephone 24-hour food 
recall, multipass method 
Researcher 
Measures adherence 
 
 
 
 
 
✔ 
✔ 
 
✔ 
 
 
 
 
24-hour Urine collection 
 
Participant 
Adherence 
 
Urinary Potassium, Sodium and 
Creatinine 
 
 
 
 
✔ 
 
 
✔ 
 
 
✔ 
 
 
Photographs of evening 
meals 
 
 
 
 
 
 
 
 
 
 
 
 
 
✔ 
 
Self-reported adherence: 
Evening meal checklist 
 
 
 
 
 
 
 
 
 
 
 
 
 
✔ 
 

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Figure 4. Flow diagram of RCT process. 
 
 
 
 

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4.0  Sample Size, Statistics, Selection and Withdrawal of Participants 
4.1 Sample size  
This study aims to recruit a total of 80 men and women, 1:1 intervention to control, to have 68 people 
(~15% dropout) complete the study. 34 people in each arm will provide 80% power to detect a 
difference of 0.468 mmol/L nocturnal glucose concentrations (SD 0.61), based on our CGM data from 
PREDICT 1 (unpublished data). Additionally, only 24 people are needed to provide 80% power to 
detect a difference of 4.2% sleep efficiency units, with SDs based on our previous sleep extension 
intervention (SLuMBER study) (7). These parameters are based on a significance level of 0.025, for 
two outcomes (calculated with G*Power software) 
4.2 Study statistical plan 
 
Mean differences between groups will be assessed at endpoint, adjusting for baseline values and 
other potential other covariates (maximum 3, as per the rule of 1 covariate per 10 participants). 
 
For the outcomes with 3 timepoints (urinary Na, K, Na:K and calystegines), this will be assessed using 
a using Linear mixed models (mixed command) with change being the dependent factor, participant 
ID as random effect, treatment and season as fixed effects, and baseline outcome as a covariate. 
Variables with 2 timepoints (all other outcomes) will be assessed with an ANCOVA regression model 
(regress command), with baseline as a covariate. BMI, sex and age may also be covariates depending 
on the balancing of the arms. Sex differences will also be explored in some outcomes with known 
sexual dimorphisms, with the use of a sex interaction term. 
 
A 2 -sided P value <0.05 will be considered as showing statistical significance.  
 
Normality will be assessed visually with histogram and Q-Q plot of residuals, and heteroscedasticity 
with a fitted-residual plot, to satisfy the model assumptions. 
 
We will primarily analyse outcomes on an intention-to-treat basis, analysing participants as 
randomised. Per-protocol analyses—restricted to participants meeting prespecified adherence 
criteria—will be performed to assess robustness. 
 
All statistics will be run on Stata/MP 18.0.  
 
 
 

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4.6 Criteria for Premature Withdrawal   
This is an ‘Intention to treat study’, participants will only be withdrawn for the reasons outlined 
below: 
1. Participant voluntarily withdraws from the study.  
2. Participant death.  
3. Participant acquires any of the listed exclusion criteria.  
Figure 5. Flow chart of the recruitment procedures 

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4. Participant’s well-being, in the opinion of the investigators, would be compromised by 
study continuation.  
If participants wish to withdraw, details on their reasoning will be formally documented. If withdrawal 
occurs after screening but prior to baseline visits, data will not be used on this participant, however if 
they withdraw during the study, the data will only be receded upon request, as stipulated in the 
information sheet (appendix 1). Data will be unable to be receded when published, and this will be 
clearly outlined in the PIS, but all data will be fully anonymised as per GDPR protocol. 
5.   Study procedures 
5.1 Informed Consent Procedures  
Upon showing interest in the study, participants will be given a Participant Information Sheet (PIS) 
(appendix 1) by email or post, to explain in detail what the study involves, their role within the trial, 
highlight the anticipated benefits and hazards of the study. This is then further accompanied by an 
introductory call, for eligible participants, to discuss the PIS and run through the consent form 
(template is in appendix 2). After this call, the consent form will be emailed to the participants to 
digitally sign online (Qualtrics form).  
Adequate time between reading the PIS and consenting will be given, to ensure there is time 
allocated for follow up questions on behalf of the participant.  
The PIS will be updated and recirculated in the event of any new information or protocol deviations, 
to confirm participants wish to continue taking part.  
Clear indication of withdrawal rights will be made known at each point of contact.  
The lead investigator and trial coordinator, Anya Klarner, has received inhouse training on Good 
clinical practice, as well has covered informed consent practises through the Human Tissues Act 
training. She will be registered on the site delegation log. 
Due to the remote nature of the initiation of the trial, informed consent will be provided remotely, to 
reduce participant burden.  
 
5.2 Risks/burdens 
Venepuncture 
Foreseeable discomfort may be experienced with the venepuncture such as: 
 
• 
Stress regarding the process  
• 
Insertion of the needle 
• 
Minor bleeding on the area where the needle was inserted. This will be covered with a 
bandage to minimise the bleeding and reduce skin exposure. 
• 
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• 
A sore arm. This is normal and will typically last 1-2 days. 
• 
During and/or after the blood sample, a participant may feel dizzy and/or faint. Should 
fainting occur, the participant will receive all the medial care required until they are fit to 
leave the Metabolic Research Unit.  
 
To minimise these risks, a trained phlebotomist will conduct the venepuncture procedure. 
 
Equipment 
For some volunteers, the requirement of self-applying equipment might cause some stress regarding 
technical capabilities. To reduce this all volunteers will be well trained through supplied multimedia 
resources, a 1:1 induction with a study team member and will have continued access to the study 
team in case of any queries.  
 
CGMs may cause slight discomfort in their application, as a very small needle will puncture the skin to 
sit just below the skin which will measure interstitial fluid glucose levels. As the sensor protrudes a 
few cm above the skin, there is a small risk that the sensors can get caught on everyday objects and 
rip out. To reduce this risk, sensor patches will be provided to cover the whole sensor and keep it 
fixed to the arm. There may be minor bleeding from the insertion of this needle, in which case 
participants are instructed to apply some pressure. If the bleeding does not stop after a few minutes 
of applying pressure, the sensor will be removed and reported to the study team. There is also the 
possibility of skin irritation to adhesives. If this is the case, the CGM should be removed, and the 
research team should be instructed for further action.   
 
Participant burden 
The initial screening and run-in session (as outlined in section 3.4, study flow), will be held remotely, 
via online documents and video/telephone calls. This we believe will reduce participant burden in 
needing to attend in-person clinics, thereby increasing study retention, and may further increase the 
comfort of the individuals.  
 
The volunteer will attend 4 events: An introductory call, a virtual run-in, and a baseline and endline 
clinic. Additionally, they will be required to apply and wear study equipment and take urinary 
samples. To negate this burden, participants will be paid upon completion of the study for their time. 
Even if participants do not complete the study, pro rata payments will be made.  
 
Dietary intervention 
Potatoes contain a natural group of toxins called glycoalkaloids, which are harmful to health in vast 
consumption, and can cause gastrointestinal symptoms, such as nausea, vomiting and diarrhoea (68). 
Guidelines at the grower level restrict the amount of these toxins available for consumption, to a 
maximum value of 200mg/kg of fresh weight potatoes (69). Despite this, these toxins can become 
concentrated within the sprouting nodules (lenticels), of aging potatoes. To reduce risks of 
glycoalkaloid consumption, participants will be instructed on how to store their potatoes to increase 

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their shelf life, as well as reducing light exposure, and will be provided with a picture of a germinating 
potato of what not to consume. Additionally, cooking and preparation methods can significantly 
reduce the glycoalkaloid concentrations (70), which will be utilised in the recipe instructions. 
 
With a change in diet, especially one with increasing fibre, it is possible volunteers may experience 
some changes in gastrointestinal motility and discomfort, such as bloating, diarrhoea or constipation. 
Any adverse effects should be immediately reported to the study team who will assist and provide 
guidance as to how to best continue. 
 
Incidental findings 
The detection of adverse or incidental findings such as undiagnosed dyslipidaemia, pre-diabetes or 
diabetes may arise following the fasted blood samples obtained during the baseline and endline visits. 
Should the blood samples result in out-of-range values, the volunteer will be informed by phone (or 
by email) and will be referred to their general practitioner (GP).  
  
Weekly blood pressure outputs from each participant will be monitored throughout the study. If 
blood pressure readings result out of range, the volunteer will be supplied with a letter to take to 
their GP for further investigation.  
 
Additionally, the use of the doppler ultrasound may highlight abnormalities in arterial health. Should 
this be the case, the same processes above are to be followed.  
 
Any out-of-range results will only be shared with the participant. The participant will be supplied with 
a letter addressed to their GP and with a copy of their results. This will be recorded in the case report 
form and the volunteer will be excluded from participating in the study. 
 
5.3 Screening Procedures  
Online screening via Microsoft form. Location at the discretion of the volunteer. 30-60 minutes.  
Participants will complete an online questionnaire screening session where they will be screened 
against the eligibility criteria (template for this is in appendix 3). The food survey will be specifically 
designed to ascertain if participants habitually consume <4 fruits and vegetables/day, habitually 
consume wholegrains, and if they do not consume red meat. 
We estimate this not to exceed 30-40 minutes.  
Data will then be reviewed by the study team, who will contact eligible participants to progress. Those 
who do meet the criteria will also be informed and thanked for their interest.  
5.4 Randomisation Procedures  
Participants will be randomised to either the intervention or control arm, with an allocation ratio of 1:1. 
A minimisation procedure will be used that considers gender, age, ethnicity, BMI) in the randomization, 
by 
using 
the 
Shiny 
App 
software, 
which 
can 
be 
accessed 
at: 

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https://fsella.shinyapps.io/VM_app/?_ga=2.186170153.125318758.1628174827-
961835063.1626383516 (71). 
Screening data will be entered into minimisation software, by the research lead (See randomisation 
SOP). This database will balance the treatment arms for the following variables:  
1. Gender. 2 groups: Male; Female  
2. Age. 2 groups: 40-59; 60‐80 y  
3. BMI. 2 groups: Healthy weight 18.5-24.9; Overweight-Obese ≥ 25 
 
Randomisation codes will be generated by the software and recorded on the relevant documentation 
in the Case Report Form and enrolment log. The randomization protocol follows the same protocol as 
used previously by our group for a parallel, two-arm, randomized controlled trial (30) for which a study 
statistician was employed. It has not been deemed necessary to employ a study statistician on the 
current trial due to the similarity of the study design, but the protocol will be discussed with a 
statistician from the King’s Joint Clinical Trials Unit. 
Participants will be blinded to whether they are receiving the intervention or the control, but it is not 
possible to blind them to the food itself. Also, as the study team is limited by resources, observer 
blinding is also impossible; however, the researcher undertaking statistical analysis will be blinded prior 
to analysis using a second set of study ID codes. FMD analysis will be conducted through semi-
automated software analyses, which will reduce bias.  
5.4 Schedule of Treatment for each visit  
Details of screening methods are summarized in Section 5.3 
NB: All times allocated are estimates. Although the study team endeavours to keep within the limits 
of these suggestions, there may be deviations due to unprecedented circumstances or varying 
participant needs. 
1st contact: Email exchange, online.  
Upon responding to advertisements, volunteers will be emailed a participant information sheet, and 
an electronic questionnaire (via Qualtrics software). All forms will be reviewed by a study team 
member and will be assessed against inclusion/exclusion criteria. Participants will be informed the 
outcome at the earliest opportunity. If eligible, participants will then be invited to attend an 
introductory call.  
2nd contact: Introductory call. Location, online, to be held at the discretion of the volunteer. 15-30 
minutes. 
All eligible participants will receive a telephone/video call (depending on the participant's preference) 
with a member of the study team, both to introduce themselves and the study. The information sheet 
will be discussed, and the consent form will be introduced. This call will serve as a chance for 
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consent. This call also allows the study team to build rapport with participants. After this call, a 
consent form (online form), will be emailed out, and upon return, they will be invited to a virtual 1:1 
run-in induction.   
Once consent is obtained, participants will be posted a ‘study pack’ consisting of:  
1. Participant information guide 
2. Study diary for writing data (sleep, BP, weight, evening meal compliance checklist) 
3. Recipes  
4. Equipment 
a. CGM (primary outcome) 
b. Motion Watch (primary outcome) 
c. Aktiia blood pressure bracelet (secondary outcome) 
d. 24-hour urine collection kits (X3) (adherence) 
e. Kitchen Scales (to weigh 24hr urine at midline) 
f. 
Bathroom scales (only if participant does not own any, secondary outcome) 
5. Equipment leaflets, including SOPs with photos for guidance. 
6. 4-day food diary incl VAS for appetite (X3) 
7. Packaging to post equipment/diaries  
3rd contact: Virtual (or in-person) run-in. Location at the discretion of the volunteer. 60 minutes.  
Before this session, volunteers will be given leaflets and videos on the equipment they will apply 
and/or measure to give them a good understanding. 
This follow-up session will be an overview and a chance for participants to ask outstanding questions. 
This will ensure that the study lead is happy that participants have suitable understanding of the 
process and are happy to continue with the process.  
A summary of the training needs that will be addressed are written below: 
Self-taken measurements include:  
1. Body weight with home scales (Weekly, from wks.0 - 12) 
Need to apply the following equipment alone:  
1. Motion watch (7days) 
2. Aktiia bracelet (7 days) 
3. CGM (12 days)  
Participants will be made aware that they are able to contact the study team at any time when they 
need. The contact details (study email and phone number) will be provided in the participant 
information guides they receive along with their equipment, as well as on email invitations.  
 

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4th contact: Clinic visit 1 (Wk 0), MRU at KCL. ~130 minutes.  
The study team will have correspondence with participants to arrange a suitable date for their 
baseline clinic visit.  
Participants will attend the MRU, 4th Floor, Franklin Wilkins Building, Kings College London and have 
the following procedures: 
1. Urine samples collected (~0 mins) 
2. Finger prick blood test (~10 minutes) 
3. Blood pressure (~10 mins) 
4. Fasted bloods (~20 mins) 
5. Heart rate variability monitor fitted (ECG), to keep on for 48-hours (~10 mins)  
6. Ultrasound imaging (~30 mins) 
7. STROOP test (~15 mins)  
8. Body composition and waist circumference (~10 mins)* 
9. Questionnaires (ZOE FFQ) (~15 mins) 
10. Dietary consultation (20 mins)*** 
*Optional break for a snack post measurements. 
**Participants will then be instructed to start the dietary protocol after 48 hours after the baseline 
clinic, when participants’ baseline HRV has been recorded.  
***Participants will be required to attend a brief consultation with the associate nutritionist on the 
dietary intervention they have been assigned to. This will cover cooking methods, appropriate food 
items, and menu card run throughs. It will also provide an opportunity to problem-solve around 
identified conflicting commitments such as holidays or celebrations, where the participants may not 
be able to follow the intervention. Standardised advice on eating out will be given to all participants. 
General healthy eating advice will also be delivered, roughly in line with UK and US dietary guidelines.  
 
5th contact: Dietary assessments for compliance  
1. Video/telephone call. 24-hour food recall, multipass method. ~30-60 mins. (Wks 2, 4, 8) 
Participants will have 2 phone calls in weeks 4 and 8, to carry out a 24-hour food recall, a well-
regarded measure of dietary intake (45). This will be conducted by an associate nutritionist, with 
experience of conducting these methods.   
Participants will be contacted by the study lead or supervised delegate, to arrange a suitable time for 
these calls.  
As the study is long-term (12 weeks) and free-living, we have built in these compliance checks to allow 
us to make suggestions to tailor the programme to the needs of the participants if necessary.  

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7th contact: Clinic visit 2 (Wk 11-12), MRU, KCL. 110 minutes 
Participants will attend the MRU, 4th floor, Franklin Wilkins Building, Kings College London for their 
final engagement. And have the following procedures: 
1. Urine samples collected (~0 mins) 
2. Blood pressure (~10 mins) 
3. Body composition and waist circumference (~10 mins) 
4. Fasted bloods (~20 mins) 
5. Ultrasound imaging (~30 mins) 
6. Heart rate variability monitor fitted (ECG), to keep on for 48-hours (~10 mins) 
7. STROOP test (~20 mins) 
8. Optional break for a snack ultrasound.  
Additional measurements made outside of the study visits:  
• 4-day diet diaries: participants will be asked to complete 4-day diet diaries during week 1, week 
6 and week 12 of the diet intervention. The 4-day diet diaries are to be completed on non-
consecutive days to reflect the intakes of 3 weekdays and 1 weekend day. It will also ask 
participants to record their satiety from their dinner, on day 1, using 100mm visual analogues 
scales, at 1-, 2- and 3-hours post meal.  
• Blood pressure will be taken at home using an automated BP bracelet. Participants will need to 
put the bracelet on during the study run, and wear it throughout the study. As the bracelet is 
no waterproof, it will need to be taken off and reapplied after bathing/water activities. It will 
also need to charged every 25 days and initialized with an accompanying blood pressure cuff 
to calibrate it.  
• Weight will be taken by the participant at home, using home weighing scales. Advice will be given 
on how to standardize these measurements to account for inter and intra variability. This 
measurement will be taken in the morning before food or drink on even hard flooring at 
monthly intervals (Table 2). Weighing scales will be provided to participants if they are not in 
possession of any.  
 
5.6 Equipment overview 
At home, at baseline and endline, participants will be wearing an Abbott’s Freestyle Libre 3 for 14 
days (A), a MotionWatch 8 for 7-days (B), a waterproof eMotion-Faros 180 for 3 days (C), and an 
Aktiia blood pressure bracelet for 14-weeks (D). Training will be given on how to apply A, B & C. D will 
be applied at the study visit.  
Participants will take their own weight weekly throughout the study (with bathroom scales, which can 
be provided if they do not own any).   
Participants will receive leaflets and/or videos on how to apply and use this equipment, entailing any 
contraindications or warnings of the study equipment (i.e. original models of Aktiia not being 
waterproof). In addition to this, all equipment will be discussed during the run-in 1:1 induction call, 

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where any questions can be asked, and the study team can check participants are comfortable and 
happy to proceed. Participants will also receive a copy of the manuals of each item via email, should 
they need to refer to it. 
All study equipment will be returned to the study team upon finishing their participation.  
 
5.7 Methods of engagement 
Engagement strategy 
As our methods are over a longer study period, we will implement the following methods to reduce 
study drop out and improve adherence: 
• 
Introductory call to build rapport 
• 
Video/telephone call through run-in induction  
• 
Compliance measures: 24-hour food recalls and food diaries 
• 
Email reminders of milestone events: Intervention start, clinic days, midline urine samples, 
when equipment has been sent.  
 
5.8 Follow up Procedures  
Not relevant for this study. 
 
5.9 Laboratory Assessments  
Fasting blood samples  
A 
B 
C 
D 

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The blood samples will be analysed at certified laboratory, Affinity Biomarker Laboratories, Suite 602, 
Cumberland House, 80 Scrubs Ln, London NW10 6RF. Tracy Neal will be the recipient of the samples 
(tracy@affinitybiomarkerlabs.com). This laboratory has been used before, so all necessary contracts 
between the laboratory and KCL have been established. Quotations for the analytes have been 
received and will be confirmed upon receiving favourable opinion from the board of ethics. 
 
The analytes and the respective diagnostic tests are summarised below.  
Analyte 
Analysis method (1) 
Full lipid profile  
Cholesterol 
Clinical Chemistry Analyser: SIEMENS 
ADIVA 1800. Chemistry cholesterol 
method. (Cholesterol (CHOL-2) reagent 
catalogue number 10376501) 
HDL 
Clinical Chemistry Analyser: SIEMENS 
ADIVA 1800. Chemistry Direct HDL 
method. (Direct HDL (HDL) reagent 
catalogue number 07511947) 
LDL 
Clinical Chemistry Analyser: SIEMENS 
ADIVA 1800.  Chemistry Direct LDL 
method. (Direct LDL reagent catalogue 
number 09796248) 
TAG 
Clinical Chemistry Analyser: SIEMENS 
ADIVA 1800. Chemistry Triglyceride 
method.  (Triglyceride (TRIG-2) reagent 
catalogue number 10335892) 
Serum potassium 
Clinical Chemistry Analyser: SIEMENS 
ADIVA 1800.  Indirect ion selective 
electrode (ISE). (ISE reagent catalogue 
number 06135445 (Potassium)) 
Plasma glucose 
Clinical Chemistry Analyser: SIEMENS 
ADIVA 1800. Chemistry Glucose oxidase 
method. (Glucose (GLUO) reagent 
catalogue number 10492319) 
HbA1C 
Clinical Chemistry Analyser: SIEMENS 
ADIVA 1800. Chemistry  A1c_E assay. 

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(1) Methods obtained from Affinity Biomarker labs. 
 
Urine samples 
The following biomarkers in urine will be analysed in the urine.  
 
 
 
 
 
 
All samples will be analysed by either the study lead or a delegated trained research student under 
their supervision, in the Department of Nutritional Science’s main laboratory, 4th Floor, Franklin 
Wilkins Building, Stamford Street, London, SE1 9NH.  
 
FMD 
Doppler ultrasound videos will be analysed using automated software (unnamed thus far) with our 
collaborators in Maastricht university, Netherlands. No laboratories will be required for their analysis.  
Ideal parameters for %FMD are between 5-8%, but this can vary on the population. As there is 
considerable overlap between healthy and non-healthy populations (72), there are no out of range 
values considered in the analysis.  
 
5.91 Radiology Assessments  
This study is proposing to use Doppler ultrasound imaging to measure brachial arterial dilation, in 
response to ‘shear stress,’ as described by the Flow-Mediated Dilation method. 
(Glycated haemoglobin HBA1 (A1c-E) 
reagent catalogue number 10720857) 
Insulin 
Siemens Adiva Centaur assay (two site-
sandwich assay). (Insulin reagent 
catalogue number 2230141) 
Analyte 
Analysis method  
Urinary potassium 
Flame photometry  
Urinary sodium 
Flame photometry 
Urinary creatinine  
Jaffe reaction via Ilab clinical 
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There is some evidence to suggest that increased potassium consumption can improve endothelium-
dependent vasodilation (73). This thought to be explained by the role of potassium in nitric oxide 
secretion, which induces vasodilation, and therefore improves the relative % increase in brachial 
arterial dilation, although specific mechanisms are not yet well understood.  
As potatoes are rich in potassium (those in the intervention group will have 1000mg extra of 
potassium per day), we hypothesize that the potato intervention arm will have higher % FMD, when 
compared to our control.  
FMD assessments will be conducted at baseline clinic visit (Wk 0) and the endline clinic visit (Wk 12), 
in the MRU, 4th Floor, Franklin Wilkins Building, Kings College London, by a trained researcher.  
As there is no ionizing radiation exposure associated with ultrasound imaging, and it is non-invasive, 
this procedure is deemed low risk.  
 
5.92 End of Study Definition  
The end of the study will be when the final study report is produced. This is anticipated to be January 
2026.  
6. Sample handling and laboratories 
 
6.1 Sample Collection, Labelling and Logging  
Sample collection 
Bloods 
Blood samples (9.5mL) on each study visit, totalling ~20mL for the whole study) will be obtained (with 
participants’ consent) by trained phlebotomists. Participants will be asked to sit or lie down and asked 
to hyperextend their arm. Venepuncture sites will primarily be the median cubital (or the largest vein 
in the antecubital fossa), and cephalic veins in the forearm. A tourniquet will be placed 3-4 inches 
above the selected puncture site and the participant’s arm cleansed using an alcohol prep wipe. Blood 
will be drawn into labelled vacutainers, mixed, and promptly delivered to the laboratory for 
processing.  
Blood collection tubes 
Vacutainers that are required for this study are summarised in the table below.  
Blood 
component 
Vacutainer (1) 
Analyte 
Sample 
required for 
analyses (ul) 
Total blood 
required (ul) 
(2) 
Number of 
vacutainers 
needed and 
Storage 
processing 

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1) 
BD Vacutainers specifications obtained at: https://www.bd.com/en-us/products-and-
solutions/products?tabindex=1&publishedAt=all-dates.  
2) 
Based on obtaining 400uL of plasma/serum for every 1mL of blood. Total amount of sample multiplied by a factor 
of 2.5. 
overall blood 
drawn 
Serum 
SST (gold 
top) 3.5mL 
 
Insulin, full lipid 
profile (Total 
cholesterol, HDL-C, 
LDL-C, TAG), serum 
potassium 
300 
~2400  
1 vacutainer 
(3.5mL) 
Samples will be 
left to clot for 
30 minutes at 
room 
temperature. 
They will then 
be centrifuged 
at 1000 X g, 
aliquoted into 
sample 
Eppendorf and 
stored at ≤ 20 °C 
 
Spare for insulin, 
full lipid profile and 
serum potassium.  
300 
 
Spare for 
exploratory 
analyses 
300 
 
Spare for 
exploratory 
analyses 
300 
Total 
1200 
Plasma 
Fluoride 
Oxalate 
(grey top) 
4mL 
Plasma glucose 
300 
~2250ul  
1 vacutainer 
(4mL) 
Samples will be 
centrifuged 
within 30 
minutes of 
collection at 
1000 x g for 15 
minutes.  
Aliquoted 
samples will be 
stored at ≤ 20 °C 
Spare for plasma 
glucose 
300 
Spare for 
exploratory 
analyses 
300 
Total 
900 
Whole blood 
EDTA (purple 
top) 2mL 
HbA1C 
200 
400ul 
1 vacutainer 
(2mL) 
Whole blood 
will be aliquoted 
into eppendorf 
and stored at 
≤ 20 °C 
Spare for HbA1C 
200 
 
 
Total 
400 
 
 
Total 
 
 
9.5mL 
 

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(total samples are 1440) 
Urine 
24-hour urine samples will be self-collected by the participant. Participants will be provided with full 
24hour urine collection kits and training on storage and methods.  
Full samples will be brought into clinic at baseline and endline and will be processed by the study lead, 
or delegated research student.  
For the midline measure, to reduce participant visits, they will be asked to record the full weight of the 
24-hour urine sample using scales that are provided by the study team. They will then be responsible 
for mixing the sample and carefully decanting their sample with use of a funnel, into a 20mL subsample 
tube. These samples will be sent to KCL via usual courier services (royal mail or UPS) for the same day 
delivery. These will be packaged in line with dangerous substances regulations, as a category B parcel, 
and will be packaged to comply with packaging instruction 650. Once these parcels have been received 
by the study team, they will be processed in the laboratory by the study team. 
Participants must fill out urinary collection forms (appendix 5), to accompany the samples at each 
time point.  
Sample Labelling:  
All participants will be assigned a unique study ID code. Participant documentation and specimens will 
be labelled with the unique study ID code which is a pseudonymised code used on all study 
documents and samples. There will be no identifiable information recorded on participant documents 
or samples. The study ID code will take the following format: 
  
 
 
 
 
 
 
 
Sample Logging and sample chain 
Fasting bloods 
The fasting blood samples collected at baseline and at the end point will be sent altogether to Affinity 
Laboratories in one batch on dry ice following storage at -80°C in a secure freezer in the Department 
STY/PARTICIPANT_ID/ 
STUDY_TIME_POINT/PARTIICPANT_ID/ANALYTE 
 
STY – STARCHy trial 
STUDY TIME POINT – Baseline or Endline 
ANALYTE – e.g., GLUC (glucose), INS (insulin) 

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of Nutritional Sciences laboratory, following processing specifications. A sample accountability log and 
a box map of the samples will be inserted into the cryogenic storage boxes and emailed to the 
recipient (Tracy Neal). 
 
All samples will have the appropriate accompanying documents and will be appropriately packaged 
and sent to Tracy Neal at Affinity Biomarker Laboratories. 
 
 
Urine 
The study team will be responsible to ensure that all containers with urine are labelled prior to 
processing. The study team will also be responsible for the labelling of subsequent samples and 
aliquots upon processing. 20mL subsample falcons will be spun down with the centrifuge at X 1300g, 
4 o C for 15 minutes to render the sample acellular. 1mL of the sample, from the top half of the 20mL 
falcon, will be pipetted into 4 Aliquots (4mL total), which will be labelled and frozen at -80 o C for 
storage.  
These samples will be analysed in batches fortnightly in the Urine lab in the MRU, via flame 
photometry.  
 
6.2 Sample Receipt/Chain of Custody/Accountability  
The fasting blood samples will be collected from participants in accordance with the participant 
consent form and participant information sheet. The custodian (Dr Wendy Hall) will use the fasted 
blood samples for the STARCHy study, only.  
  
The fasting blood samples will be appropriately sent using a medical courier to Tracy Neal (Affinity 
Biomarker Laboratories) who will process, store, and dispose of the fasting blood samples in 
accordance with all applicable legal and regulatory requirements, including the Human Tissue Act 
2004 and any amendments thereto.  
 
Additionally, midline urine samples will be sent to the laboratory at KCL in line with transporter 
regulations.  
 The recipient shall only use the fasted blood samples and urine in accordance with the consent 
provided by the participants and shall always treat these samples with the upmost of care alongside 
safe laboratory practices.  
  
The fasting blood samples and urine will not be transferred to any party not identified in this protocol 
and are not to be processed and/or transferred other than in accordance with the participants’ 
consent.  After ethics approval for the study has expired, the fasting blood samples will be disposed of 
in accordance with the Human Tissue Act 2004. 
 

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6.4 Sample Storage Procedures (if applicable)  
Urine and blood sample aliquots will be racked in 10x10 cryogenic storage boxes.  Each aliquot will be 
labelled with the participant study ID code and the time point of collection.  The storage boxes will be 
labelled according to the analyte measured.  The sample storage will be mapped on an excel 
spreadsheet and a printed copy of this box map will be inserted into completed boxes.  The storage 
boxes will be stored in -80°C freezers at FWB at KCL.  The ‘spare’ aliquots will be used if there are any 
losses during analysis. Long-term storage of spare aliquots will be in FWB, 4th floor laboratory, in 
freezers approved by the Human Tissues Authority, which are supplied with a back-up power source 
and card ice/dry ice.  
The sample custodian is Anya Klarner, under the supervision of Dr Wendy Hall and Dr Sarah Berry and 
Dr Wendy Hall, who will be responsible for the safe keeping, analysis, and disposal of the samples. 
 
6.5 Data Recording/Reporting  
All researchers involved in the study will undertake HTA training prior to commencing work on the 
study.  
The recruitment (eligibility) questionnaire will be used to record non-anonymised data such as names, 
addresses, email, and telephone number details, which will be on the same document used to record 
medical history, lifestyle, and body measurements. If volunteers are not eligible or not interested in 
participating and do not proceed to the screening visit, these questionnaires will be shredded and 
disposed of. 
Eligible volunteers will be assigned a participant code at the screening visit. At the screening visit all 
further records, databases and reports will refer to each participant by their code, not by their name. 
Recruitment questionnaires containing identifiable information will be kept securely in a locked 
cupboard in a locked office (Room 4.43, 4th floor, Franklin−Wilkins Building, King's College London, 150 
Stamford Street, SE1 9NH) during the study. Personal data held within computers will be password 
protected and stored on encrypted memory sticks or restricted server access when not in use. Access 
to such data will be granted only to appropriate members of the research team. On completion of the 
study, the research project’s paper records will be archived in a filing cabinet in Dr Hall’s locked office. 
Data will be entered onto an Excel spreadsheet database. 
Medical results will not be disclosed to any other party than the participant, and their GP by providing 
the participant with a letter addressed to their GP (with the participant's permission). The research 
records will be held securely at King's College London, according to the Data Protection Act 2018 and 
General Data Protection Regulation (EU) 2016/679, and in accordance with the College Guidelines 
7. Assessment of Safety  
 

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7.1 Adverse events 
Expected advents: the following adverse events may occur during the study and will not require 
formal reporting to the authorities.  
Study Procedure 
Anticipated Risks 
Risk Mitigation 
Venepuncture 
Discomfort, slight bruising, fainting 
 
Trained phlebotomists will perform all blood 
draws. Strict aseptic technique. 
CGM 
application/venepuncture 
Skin Irritation from adhesives 
Participants will be asked if they have sensitive 
skin and are usually allergic to plasters. In this 
case, we will find allergenic alternatives or may 
need to exclude them from the study.  
FMD/ 
Bruising from cuff inflation, especially 
from FMD arterial occlusion 
For these processes we are required to reach 
certain pressure from the cuff, so although it 
will not be able to be mitigated, participants will 
be forewarned of this effect to reduce stress 
surrounding the presence of bruising.  
Health screening 
Possibility of detecting undiagnosed 
dyslipidaemia, pre/diabetes 
 
Participant’s GP will be informed of results and 
early treatment can be initiated. 
Ultra-sound scanning  
Possibility of detecting cardiac 
abnormalities (atherosclerosis) 
 
A referral for further investigation will be made 
if any abnormalities are detected. 
 
Fasting blood testing  
Possibility of fainting 
Participants more prone to fainting (as known 
through screening as well as those with low 
blood pressure as defined in the venepuncture 
protocol, will have their bloods taken lying 
down to reduce risk of unconsciousness). The 
phlebotomist will also be trained to deal with an 
unconscious participant and will never be alone 
in the MRU unit.  
 
 
7.2 Serious Adverse Events 
The Principal Investigators (Dr Wendy Hall and Dr Sarah Berry) will oversee the safety of the study, 
including careful assessment and appropriate reporting of adverse/serious adverse events (AEs, SAEs) 
(appendix 6), following the ‘Adverse Events Form Guidance’ and Adverse event flow diagram 

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(appendix 7), provided by KCL’s Research Governance Office. Reports of SAEs will be submitted within 
15 days of the principal investigator becoming aware of the event, using ‘Serious Adverse Events 
Reporting Form’.  
8. Ethics & Regulatory Approvals  
The study will be conducted following the principles of the Declaration of Helsinki (2013), the 
principles of GCP and in accordance with all applicable regulatory requirements including but not 
limited to the UK policy framework for health and social care research and the Mental Capacity Act 
2005. 
 
This protocol and related documents will be submitted for review to Kings College London Health 
Faculties Research and Ethics subcommittee, Waterloo Campus, 57 Waterloo Road, London, SE1 
9WA. 
Any subsequent protocol amendments will be resubmitted for approval before implementation. The 
Principal Investigator will submit a final report at conclusion of the trial to the funder and the REC.  
 
9. Data Handling 
9.1 Confidentiality  
Volunteers will be randomised and assigned a participant code. Following screening and acceptance 
onto the study, all further sample labels, records, databases, and reports will refer to each participant 
by their code, not by their name. All samples, records, databases, and reports will be kept in a safe place 
and only the Principal Investigators and research students will have access to them. Medical results will 
not be disclosed to any other party than the participant, and their GP by providing the participant with 
a letter addressed to their GP (with the participant's permission). The research records will be held 
securely at King's College London, according to the Data Protection Act 2018 and General Data 
Protection Regulation (EU) 2016/679, and in accordance with the College Guidelines. The Principal 
Investigators and other members of the research team will have access to the anonymised data.  
Participants' personal details (name, address, etc) will be kept securely in the Research Team's office 
(Nutritional Sciences Division, Franklin−Wilkins Building). Personal data stored in filing cabinets, 
cupboards and/or rooms will be kept in a locked room when not in use. Personal data held within 
computers, will be password protected and stored on restricted server access when not in use. Access 
to such data will be granted only to appropriate members of the Research team. Extra care will be taken 
to ensure the security of research material containing personal data, which is participant to the 
provisions of the UK GDPR, under the Data Protection Act, 2018. 
Data will include questionnaires (paper and electronic), laboratory analysis results (electronic), vascular 
and ultrasound images (electronic) and case report forms (paper and electronic). 
Data will be collected and labelled as outlined in section 5.0. 
The principal investigators will be custodians of the data. 

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Participant details will not be transferred outside of the EU.  
The patients will be anonymised with regards to any future publications relating to this study. 
 
9.2 Case Report Form 
Digital Case report forms (CRFs) will be completed by the PhD student, or trained delegate student. 
They will be completed after every study visit. The following will be included in CRFs: 
 
1. Inclusion/exclusion criteria 
2. Randomisation form 
3. Date of informed consent 
4. Date of birth 
5. Current medications 
6. Notes of participant’s general wellbeing on study days 
7. Participant eligibility prior to study days: i.e., adherence to diet intervention and fasting 
protocol  
8. Visit dates  
9. Visit number 
10. Participant randomisation number 
11. Blood glucose (from finger prick test) 
12. Blood pressure measurements 
13. Weight 
14. Waist circumference 
15. Body composition (%body fat). 
16. Notes and checklists for: 
- 
24-hour urine 
- 
HRV 
- 
FMD 
- 
Aktiia BP watch 
17. Urine collection form 
18. Copy of data from home data diaries: 
- 
Home weight measures 
- 
Evening meal adherence checklist 
- 
Sleep and wake times 
19. STROOP test time, and results. 
20. Any study interventional delays and reasons if able to state 
21. AEs 
22. Page for toxicities 
23. Withdrawal from study 
24. Study completion 
25. Follow up of outcomes 
26. Death 
27. SAE form 
28. Comments form 

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9.3 Record Retention and Archiving 
Anonymised data from the study will be stored for at least 10 years as outlined above in the 
confidentiality section of the data handling section.  
9.4 Compliance 
The Chief Investigators will ensure that the trial is conducted in compliance with the principles of the 
Declaration of Helsinki (1996), and in accordance with all applicable regulatory requirements including 
but not limited to the Research Governance Framework, Trust and Research Office policies and 
procedures and any subsequent amendments. 
9.5 Clinical Governance Issues 
The investigator will permit study-related monitoring, audits, and inspections by the Ethics Committee, 
the sponsor, government regulatory bodies, and University compliance and quality assurance groups 
of all study related documents (e.g., source documents, regulatory documents, data collection 
instruments, study data etc.).  Participation as an investigator in this study implies acceptance of 
potential inspection by government regulatory authorities and applicable University compliance and 
quality assurance offices.   
9.6 Non-Compliance      
   Compliance will be monitored from several sources as outlined below: 
1. 24 hr diet recalls 
2. Urine sample analysis (potassium levels, as indicated by intake) (baseline, midline and endline) 
3. Daily photographs of evening meals 
 
A 24-hour dietary recall is a dietary assessment method that involves asking individuals to recall all the 
food and beverages they consumed in the past 24 hours. This method can be used to assess compliance 
with a dietary intervention by comparing the reported food intake to the prescribed dietary intake. 
During the 24hour dietary recall, the trained nutritionist will used a standardised protocol to assess 
compliance from answers. Upon finding compliance issues, this will be noted, and the nutritionist will 
make informed suggestions to increase access to the diet. These persons will be noted and will receive 
email follow ups to see if the suggestions aided adherence in the following weeks, between recalls.   
 
The researchers will maintain a log of the non-compliances to ascertain if there are any trends 
developing which need to be escalated. The researcher will assess the non-compliances and action a 
timeframe in which they need to be dealt with.  
11. Finance and Publication Policy  
Source of funding 
Alliance for Potato Research and Education (APRE) 
PO Box 803312 
Chicago, IL 60680  
Email: research@apre.org  

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Amount of funding 
$185,166 USD 
 
Kings College London will receive and manage the funding in accordance with specification outline in 
the Agreement between KCL and APRE (APRE_KCL_Agreement_Revised).                       
 
The data for the study will be published in manuscript form in peer review journals and in abstract and 
poster format at conference proceedings/ presentations according to the research agreement between 
the 
Alliance 
for 
Potato 
Research 
and 
Education 
and 
Kings 
College 
London 
(APRE_KCL_Agreement_Revised). In brief, Kings College London will be free to publish the results of the 
research after providing the Alliance of Potato Research and Education with a 30-day period in which 
to review each publication for potentially patentable information.  
Following ethical approval, the study will be registered at clinicaltrials.gov. 
 
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Review. The Journal of Clinical Hypertension. 2016;18(5):456-67. 
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Knuiman JT, Hautvast JG, van der Heijden L, Geboers J, Joossens JV, Tornqvist H, et al. A 
multi-centre study on within-person variability in the urinary excretion of sodium, potassium, 
calcium, magnesium and creatinine in 8 European centres. Hum Nutr Clin Nutr. 1986;40(5):343-8. 
43. 
Murakami K, Sasaki S, Takahashi Y, Uenishi K, Watanabe T, Kohri T, et al. Sensitivity and 
specificity of published strategies using urinary creatinine to identify incomplete 24-h urine 
collection. Nutrition. 2008;24(1):16-22. 
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Centers for Disease Control and Prevention. National Health and Nutrition Examination 
Survey (NHANES): 24-hour Urine Study Procedures Manual. 2017. 
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Holmes B, Dick K, Nelson M. A comparison of four dietary assessment methods in materially 
deprived households in England. Public Health Nutrition. 2008;11(5):444-56. 
46. 
Drennan MD, Kripke DF, Klemfuss HA, Moore JD. Potassium affects actigraph-identified 
sleep. Sleep. 1991;14(4):357-60. 
47. 
Blanch N, Clifton PM, Petersen KS, Keogh JB. Effect of sodium and potassium 
supplementation on vascular and endothelial function: a randomized controlled trial. Am J Clin Nutr. 
2015;101(5):939-46. 
48. 
Bakhshi B, Sultana N, Lin H, Fei D, Vallejo V, Gatanti A, et al. Associations of diet composition 
and quality with continuous glucose monitor-derived glycemic metrics in a community-based cohort. 
The American Journal of Clinical Nutrition. 2025. 
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Ashor AW, Werner AD, Lara J, Willis ND, Mathers JC, Siervo M. Effects of vitamin C 
supplementation on glycaemic control: a systematic review and meta-analysis of randomised 
controlled trials. Eur J Clin Nutr. 2017;71(12):1371-80. 
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D'Elia L, Masulli M, Cappuccio FP, Zarrella AF, Strazzullo P, Galletti F. Dietary Potassium 
Intake and Risk of Diabetes: A Systematic Review and Meta-Analysis of Prospective Studies. 
Nutrients. 2022;14(22). 
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Akilen R, Deljoomanesh N, Hunschede S, Smith CE, Arshad MU, Kubant R, et al. The effects of 
potatoes and other carbohydrate side dishes consumed with meat on food intake, glycemia and 
satiety response in children. Nutrition & Diabetes. 2016;6(2):e195-e. 
52. 
Merino J, Linenberg I, Bermingham KM, Ganesh S, Bakker E, Delahanty LM, et al. Validity of 
continuous glucose monitoring for categorizing glycemic responses to diet: implications for use in 
personalized nutrition. Am J Clin Nutr. 2022;115(6):1569-76. 
53. 
Wyatt P, Berry SE, Finlayson G, O’Driscoll R, Hadjigeorgiou G, Drew DA, et al. Postprandial 
glycaemic dips predict appetite and energy intake in healthy individuals. Nature Metabolism. 
2021;3(4):523-9. 
54. 
Berry S, Bermingham K, Smith H, Gonzalez J, Duncan E, Valdes A, et al. Glycaemic variability, 
assessed with continuous glucose monitors, is associated with diet, lifestyle and health in people 
without diabetes. 2023. 
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Predicts Incident Cardiovascular Events in Older Adults. Circulation. 2007;115(18):2390-7. 
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Pinto AM, Bordoli C, Buckner LP, Kim C, Kaplan PC, Del Arenal IM, et al. Intermittent energy 
restriction is comparable to continuous energy restriction for cardiometabolic health in adults with 
central obesity: A randomized controlled trial; the Met-IER study. Clinical Nutrition. 2020;39(6):1753-
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Pinto AM, Maclaughlin HL, Hall WL. Heart Rate Variability and Long Chain n-3 
Polyunsaturated Fatty Acids in Chronic Kidney Disease Patients on Haemodialysis: A Cross-Sectional 
Pilot Study. Nutrients. 2021;13(7):2453. 
60. 
Pinto AM, Sanders TAB, Kendall AC, Nicolaou A, Gray R, Al-Khatib H, et al. A comparison of 
heart rate variability, n-3 PUFA status and lipid mediator profile in age- and BMI-matched middle-
aged vegans and omnivores. British Journal of Nutrition. 2017;117(5):669-85. 
61. 
Satija A, Bhupathiraju SN, Spiegelman D, Chiuve SE, Manson JE, Willett W, et al. Healthful 
and Unhealthful Plant-Based Diets and the Risk of Coronary Heart Disease in U.S. Adults. J Am Coll 
Cardiol. 2017;70(4):411-22. 
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Fung TT, Meyer HE, Willett WC, Feskanich D. Association between Diet Quality Scores and 
Risk of Hip Fracture in Postmenopausal Women and Men Aged 50 Years and Older. Journal of the 
Academy of Nutrition and Dietetics. 2018;118(12):2269-79.e4. 
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connections with host metabolism and habitual diet from 1,098 deeply phenotyped individuals. 
Nature Medicine. 2021;27(2):321-32. 
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Vadiveloo M, Parekh N, Mattei J. Greater healthful food variety as measured by the US 
Healthy Food Diversity index is associated with lower odds of metabolic syndrome and its 
components in US adults. J Nutr. 2015;145(3):564-71. 
65. 
Beckmann M, Lloyd AJ, Wilson T, Torres DPM, Goios ACL, Willis ND, et al. Calystegines are 
Potential Urine Biomarkers for Dietary Exposure to Potato Products. Molecular Nutrition & Food 
Research. 2020;64(20):2000515. 
66. 
Sanders LM, Dicklin MR, Palacios OM, Maki CE, Wilcox ML, Maki KC. Effects of potato 
resistant starch intake on insulin sensitivity, related metabolic markers and appetite ratings in men 
and women at risk for type 2 diabetes: a pilot cross‐over randomised controlled trial. Journal of 
Human Nutrition and Dietetics. 2021;34(1):94-105. 
67. 
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Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193-213. 
68. 
EFSA. Outcome of a public consultation on the draft risk assessment of glycoalkaloids in feed 
and food, in particular in potatoes and potato‐derived products. EFSA Supporting Publications. 
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69. 
Friedman M. Potato Glycoalkaloids and Metabolites:  Roles in the Plant and in the Diet. 
Journal of Agricultural and Food Chemistry. 2006;54(23):8655-81. 
70. 
Nie X, Zhang G, Lv S, Guo H. Steroidal glycoalkaloids in potato foods as affected by cooking 
methods. International Journal of Food Properties. 2018;21(1):1875-87. 
71. 
Sella F, Raz G, Cohen Kadosh R. When randomisation is not good enough: Matching groups 
in intervention studies. Psychonomic Bulletin & Review. 2021;28(6):2085-93. 
72. 
Bots ML, Westerink J, Rabelink TJ, de Koning EJ. Assessment of flow-mediated vasodilatation 
(FMD) of the brachial artery: effects of technical aspects of the FMD measurement on the FMD 
response. Eur Heart J. 2005;26(4):363-8. 

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73. 
Blanch N, Clifton PM, Keogh JB. A systematic review of vascular and endothelial function: 
effects of fruit, vegetable and potassium intake. Nutr Metab Cardiovasc Dis. 2015;25(3):253-66. 
 
 
 

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11. 
Appendices 
Appendix 1. Participant Information Sheet 
 
Participant Information Sheet  
Title of project  
STARchy staples: a randomised clinical trial on Cardiometabolic Health.   
Short title: The STARCHy study.   
 
Invitation  
You are being invited to take part in a research project at Kings College London. Before you decided 
it is important for you to understand why the research is being done and what participation will 
involve. Please take time to read the following information carefully and discuss it with others if you 
wish. Ask us if there is anything that is not clear or if you would like more information. Take time to 
decide whether you wish to take part. Thank you for reading this.  
 
What is the purpose of this study?   
This study aims to investigate the health effects of consuming starchy staples in an evening meal, 
including effects on sleep quality, nocturnal blood sugars, arterial health, fasting blood profiles, 
blood pressure and other related parameters. As this study is focused on habitual consumption, the 
duration needs to reflect a long period, which is why this study is set to last for 12-weeks. There will 
be a two-week run-in period prior to starting to ensure you are comfortable with the study process 
and one-week after baseline to standardise both groups, so in total the trial will span 14-weeks.  
The data collected from the trial will help us to understand the nutritional benefits of the 
intervention foods, and in the longer-term help shape dietary advice for the prevention of chronic 
diseases.   
 
Why have I been asked to take part? 
You have been asked to take part as you are an adult in the London area, who has interests in being 
involved in clinical trials. To be eligible for the study, you must be between 40-80 years of age. There 
are other eligibility criteria which will be assessed via a questionnaire in the screening call. In total, 
we aim to recruit a total of 80 participants in the study.  
Do I have to take part? 
No. It is up to you to decide whether to take part and your decision to not take part will not impact 
you in any way. If you do decide to take part, you will be given this information sheet to keep and be 
asked to sign a consent form prior to enrolling. 

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You can withdraw at any time without giving a reason, although for this we do appreciate you 
notifying us.  
What will happen to me if I take part?  
This study will involve you consuming self-prepared evening meals containing starchy foods. All 
participants will be split into 2 groups, both consuming different starchy foods in their evening meal. 
Is it not possible to blind you to which diet you will be consuming, as you will be preparing it, 
however, to improve the quality of the data, you will be concealed to whether what you’re 
consuming is the intervention (what we’re investigating), or the control (what we’re comparing 
against).  NB: If you choose to enrol, you will not get to decide which group you are allocated to as 
this process is randomised. The recipes for these meals will be provided on recipe cards and will be 
very simple and easy to follow.  
In terms of your study involvement, you will be asked to attend an initial introductory call to meet 
the study team, a 60-minute virtual induction to run through the study equipment, a 20 minute 
online dietary consultation, and 2 clinic visits at week 1, and then at again at week 12 (both lasting 
an estimate of 120 minutes).  
During the clinic visits, we will take a finger prick blood sample, fit a small painless and safe heart 
rate monitor with 2-leads: one connecting to a pad on your upper chest (collar bone) and lower 
chest (rib cage), to leave on for 48 hours (10 mins). We will then take fasting bloods (10 mins), an 
ultrasound image of your arm (30 mins), your weight, height, waist circumference and body fat % 
(10 minutes). Lastly you will be asked to complete a brief computer game (15 minute) and food 
frequency question (15 mins). 
For the clinic visits, you will be reimbursed for travel expenses of up to £10.  
Before your clinic visits at week 1 and week 12, and at week 6 at home, we will ask you to provide a 
24-hour urine sample for us to use for analysis of study related biomarkers. All equipment will be 
provided, and training will be given. Courier services will be provided where necessary.  
The urine and blood samples will be handled in line with the Human Tissues Act regulations. We will 
dispose of any unused material in accordance with these regulations. 10mL of blood and 
approximately 10mL of urine will be taken at week 1 and week 12, with a further 10mL of urine at 
week 6, which will be taken by you at home.  
There will also be 3 telephone calls (~60 minutes) at weeks 2, 4 and 8 for a dietary assessment, to 
ensure that you’re coping well with the study and so to be able to provide personalised advice to 
tailor the programme to suit your needs. Further, a food diary will be provided, and you’ll be asked 
to fill in everything you eat prospectively for 4 days at weeks 1, 6 and 12.  
To reduce clinic visits, we will provide you with some study equipment to take readings yourself at 
home. These include blood pressure monitors, continuous glucose monitors and urine collection kits 
that you will need to use at the beginning of the study and again at the end. We will provide full 

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training on this equipment through leaflets, videos, and tutorial instruction in the induction video 
call. The study team will also be on hand to answer any arising issues so you will have plenty of 
support.  
We appreciate this is a lot of information so below is a schematic for you to visualise the process.  

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What do I have to do?  
To enrol in the study, you will firstly need to sign the consent form.   
During the study you will need to adhere to the evening meal plans as instructed on the menu cards 
for a total of 14-weeks. You will be required to consume these meals ideally before 8:00pm.  
 
You will need to be willing to attend all eight events with the study’s associate nutritionist, including 
three virtual video calls, three telephone calls and two clinic visits at King College London, Waterloo 
campus, Franklin-Wilkins Building. Further you will be asked to provide 2 fasting blood samples, 
three 24-hour urine samples, two ultrasound images of your arm and three 4-day food diaries.  
  
You will further be asked to apply some equipment at home that will be provided to you (continuous 
glucose monitor, Motionwatch and blood pressure machines), and to take some equipment readings 
(weight, blood pressure) at regular intervals from home throughout the study, after training. You will 
be asked to write your measurements down into a data diary which will be broken up into 3 month 
stages.    
 
You will also be asked to record your sleep time for one week whilst wearing the sleep monitoring 
Motionwatch at week 1 and again at week 12. Lastly, we will ask you to take a picture of your 
evening meal in addition to a written record of what you ate for the 12-weeks. You will be provided 
with a small booklet to keep these recordings together and we will collect it at the end of the trial. 
 
What study equipment be used?  
You will be using a range of different equipment, both at home and within the clinic. So here is just a 
brief summary:  
At home, at baseline and endline, you will be wearing a continuous glucose monitor for 14 days (A), 
an activity tracking watch (MotionWatch) for 7-days (B), a heart rate variability monitor for 3 days 
(C), and a 24-hour blood pressure machine for 24 hours (D). Training will be given on how to apply A 
& B. C & D will be applied for you at the study visit. You will also receive a copy of the manuals of 
each via email.  
Intermittently throughout the study you will be using a 
blood pressure machine, that will be provided, and you 
will weigh yourself using bathroom scales. If you do not 
own your own bathroom scales, we will provide these for 
you.  
Additionally, in clinic, a study team member will use an 
ultrasound to scan to get a video image of your brachial 
artery, running through your upper arm.    
None of the study equipment is harmful. 
A 
B 
D 
C 

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All study equipment will be returned to the study team upon finishing your participation.  
When will I have to do it? 
Once you reply confirming you have read this information sheet and would like to proceed, we will 
email you an online screening questionnaire. If you are eligible, we will arrange an introductory call 
with the study team. This study is aiming to recruit participants from the earliest June 2023 to the 
latest August 2024. 
What are the possible disadvantages and risks of taking part?  
Some participants may feel discomfort in having their bloods taken. This procedure will be carried 
out by a trained and experienced researcher, with assistance from an onsite paramedic. 
Some participants may experience a change in bowel habit following changes to their diet, such as 
bloating, diarrhoea or constipation. Any adverse reactions arising from the diet must be reported 
directly to the trial team who will provide guidance on how best to continue.  
The pressure initiated from the blood pressure monitor cuff may induce some bruising, although this 
is not dangerous, it may be tender for a few days. The 24-hour blood pressure measures, requires a 
monitor to be worn for 24 hours. The cuff will inflate at regular intervals, throughout the day and the 
night, which may cause some disruption of sleep. The degree of cuff inflation will adjust based on 
your blood pressure so this should be less obvious during the night.   
During the ultrasound imaging, you will wear a tight blood pressure cuff for 5 minutes on your lower 
right arm. This may induce some discomfort, such as numbness and ‘pins and needles’, but this is 
completely normal and will not affect long-term blood flow.  
Travelling with the 24-hour urine sample may cause some inconvenience for participants. Suitable 
equipment for transporting these samples will be provided to ensure safe passage.  
Study visits could be up to 2 hours, which we are aware may cause some inconvenience. For around 
1 half hours of this, you will need to be in the fasted state as measurements can be inaccurate when 
foods are eaten. The study lead will ensure to be as quick and thorough as possible in the time 
available. Toast or a cereal bar will be provided as a snack to consume after the clinical 
measurements have been made.  You’re also welcome to bring in other snacks for after the 
measurements, which can be consumed in the onsite dining facility.  
ECG pads will need to worn on the chest during the ultrasound imaging process. This may cause 
some distress for those who do not wish to show their skin, or to remove their top. To mitigate 
against this, we suggest that you wear light and baggy clothing, or strappy garments, so the pads can 
be accessed without needing to remove your top. There is also the option for you to apply these 
yourself with instruction from the study team member. 

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Additionally, ECG pads on the collar bone and on the rib cage will need to be applied for the heart 
rate variability monitor (see diagram C above). Any chest hair local to where the pads will need to be 
attached will need to be shaved. 
The blood sampling may reveal some undiagnosed conditions, such as dyslipidaemia, pre-diabetes or 
diabetes, due to the parameters we are testing. Additionally, your blood pressure readings may 
indicate signs of hypertension. Should your samples come back with out-of-range values, you will be 
informed at the earliest by phone (or by email) and will be referred to your general practitioner (GP).  
What are the possible benefits of taking part? 
You will receive dietary advice from an AfN registered Associate Nutritionist on healthy eating and 
lifestyle practice and will have access to nutritionist approved meal recipes and cooking techniques 
to maximise available nutrients, which you’re able to keep post study.  
You will also have training on state-of-the-art health technology that will be provided for free, for 
use during the study. 
We also hope that you will feel satisfaction in your ability to help shape dietary advice on chronic 
disease prevention, by providing your data. You are also welcome to receive a copy of the final 
report upon request. 
Lastly, we offer £100 renumeration for your commitment to this study. 
 
What if something goes wrong? 
If you have any concerns with the day to day running of the trial, or need further assistance, your 
questions will be welcomed by the study teams lead, Anya Klarner, who can be contacted at 
starchy@kcl.ac.uk. If you wish to report an adverse event, as defined as an undesired effect of the 
intervention, please forward the event along with a through description to the above address or call 
the study team on XXXXXXXX. If you experience any other symptoms, please use your usual means 
of care, such as your doctors surgery or emergency care, as you see fit.   
 
Alternatively, if you wish to raise a complaint, you can do this by contacting the co-ordinating 
supervisor, Dr Wendy Hall, at wendy.hall@kcl.ac.uk.   
 
Kings College London holds insurance policies which apply to this study. If you experience harm or 
injury from taking part in this study, you may be eligible to claim compensation.    
 
What samples will I have to provide and what will happen to them?  
This study will require 2 blood tests, one at the baseline study visit, and one at the last study visit in 
week 12. At each visit we will take 10mL of blood (3 small tubes). These samples will be processed 
and frozen in Kings college London’s labs in accordance with the Human Tissues Act.  These blood 

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samples will be analysed by a certified laboratory, Affinity Biomarker Laboratories (Suite 602, 
Cumberland House, 80 Scrubs Ln, London NW10 6RF).  
2 serum samples (with no human cells) will be stored for future investigative analysis for additional 
nutrients, but this will not contain any identifiable information.  
The study also requires you collect 24-hour urine, at baseline and endline study visits, which will be 
processed by the study team in clinic, and then again at home in the middle of the study, which you 
will process and post a sub-sample. In each 24-hour collection, we will take a small sub-sample of 
20mL, and then freeze 4mL of this. The rest will be safely discarded. The analysis of these samples 
will be in-house at Kings laboratories.  
Will my taking part in this project be kept confidential? 
Yes, all the information that we collect about you during the research will be kept strictly 
confidential. Any traceable information will be stored in a secure premises with restricted access for 
the study lead and their direct supervisor. Any identifiable data will be destroyed within 3-years of 
the study end date, which is estimated to be 01/02/2029, unless you wish to stay on the mailing list 
for further studies. You will not be identifiable in any ensuing reports or publications. Upon 
enrolling, you will be given a unique code to label your samples and ultrasound images, so you are 
untraceable. All data procedures are compliant with GDPR regulations. 
Should you require further information on this, please do get in touch. 
What will happen to the results of the research project?  
These results will be used to write up a scientific article, with the aim to publish in a nutrition related 
scientific journal. This is estimated to be submitted in Feb 2026. Please note, you will not be 
identifiable in any report or publication. An email will be circulated to all study participants to inform 
them of any publications should you be interested in reading it. 
Who is organising the research?  
This trial is being organised by a PhD candidate, Anya Klarner, on behalf of the Department of 
Nutritional Sciences, Kings College London, in fulfilment of a doctoral degree. This study is 
supervised by Associate Professors within the department, Dr Wendy Hall, who can be contacted via 
email at wendy.hall@kcl.ac.uk and Dr Sarah E Berry, on sarah.e.berry@kcl.ac.uk. 
This research is being funded by an Industry-associated not-for-profit organisation. Further details 
on the organisation will be provided upon completion of the study, so to reduce bias in the results. 
Any queries on this please don’t hesitate to get in touch.   
Can I change my mind about taking part? 
Yes, you can withdraw from the study at any time.  You just need to tell the researcher (Anya), that 
you don’t want to be in the study anymore.   
  

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Should you decide to proceed with the study, you can keep a copy of this information sheet for 
reference throughout the study. You will also be given a copy of a consent form that you will need to 
sign after the introductory call to progress in the study.  
 
Thank you for your attention! 
 
 

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Appendix 2. Informed consent declaration form  
CONSENT FORM FOR PARTICIPANTS IN 
RESEARCH PROJECTS  
 
Please complete this form after you have read the Information Sheet 
and/or listened to an explanation about the research 
 
Title of project: STARchy staples: A randomised controlled trial on Cardiometabolic Health 
Ethical review reference number: HR/DP-22/23-35587 
 
Version number: 1, 17/03/23 
 
 
Tick or 
initial 
1. I confirm that, to my knowledge, I meet the following criteria:  
I am 40-80 years old.  
I do not have a history of heart disease, stroke, high blood pressure, diabetes, 
chronic gastrointestinal disorder. 
I do not have a history of excess alcohol intake or substance abuse.  
 
2. I confirm that I have read and understood the participant information sheet, dated 
10/03/23 Version 1, for the above project. I have had the opportunity to consider the 
information and asked questions which have been answered to my satisfaction. 
 
3. I consent voluntarily to be a participant in this project and understand that I can refuse 
to take part and can withdraw from the project at any time, without having to give a 
reason, up until January 2025.  
 
4. I consent to the processing of my personal information for the purposes explained to 
me in the Information Sheet. I understand that such information will be handled under 
the terms of UK data protection law, including the UK General Data Protection 
Regulation (UK GDPR) and the Data Protection Act 2018. 
 
5. I understand that my information may be subject to review by responsible individuals 
from the College for monitoring and audit purposes. 
 
6. I understand that confidentiality and anonymity will be maintained, and it will not be 
possible to identify me in any research outputs  
 
7. I agree that the researcher/ research team may use my data for future research and 
understand that any such use of identifiable data would be reviewed and approved by 
a research ethics committee. (In such cases, as with this project, data would not be 
identifiable in any report). 
 

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8. I understand that I must not take part if I fall under the exclusion criteria as  
detailed in the information sheet and explained to me by the researcher. 
 
 
9. I have informed the researcher of any other research in which I am currently involved 
or have been involved in during the past 12 months 
 
10. I understand that the information I have submitted will be published as a report 
 
11. I consent to the collection (20mL) and storage of my blood 
 
12. I consent to the collection (24-hour samples) of my urine, and the storage of 8mL for 
analysis on this project. 
 
13. I consent to participate in the use of an ultrasound scan on my arm, and the recording 
of pseudonymised ultrasound video (15 minutes). 
 
14. I agree to be re-contacted in the future by King’s College London researchers 
regarding this project.   
 
Optional 
15. I agree that my GP may be contacted if any unexpected results are found in relation 
to my health. 
 
16. I wish to receive a copy of the final report. 
 
17. I agree that the researcher may retain my contact details so that I may be contacted 
in the future by King’s College London researchers who would like to invite me to 
participate in future studies of a similar nature. 
 
 
 
__________________               __________________              _________________ 
Name of Participant                 Date 
 
 
       Signature 
 
 
__________________               __________________              _________________ 
Name of Researcher                 Date 
 
                  Signature 
 
 

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Appendix 3. Eligibility questionnaire, word template    
 
Screening Questionnaire 
Demographics 
 
1. 
What gender were you assigned at birth? 
MALE 
 
FEMALE 
 
 
 
 
2. 
What is your age? 
 
Years 
 
 
 
 
3. 
How tall are you? 
 
 
 
 
metres 
 
cm 
OR 
 
feet 
 
inches 
 
 
4a. 
What is your weight? 
 
 
 
 
kilograms 
OR 
 
stones 
 
pounds 
 
4b. 
Have you had weight loss >3kg in the last 2 months? 
 
 
 
Yes 
 
No 
 

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5.  What is your ethnic group? 
White 
 
 
Asian or Asian British 
 
British 
 
Indian 
Irish 
 
Pakistani 
Other White background 
 
Bangladeshi 
Mixed 
 
 
Other Asian background 
White and Black Caribbean 
 
Black or Black British 
 
White and Black African 
 
Caribbean 
White and Asian 
 
African 
Other Mixed background 
 
Other Black background 
 
 
 
Chinese 
 
 
 
Any other Group 
 
 
 
 
 
 
Health 
 
5. 
Over the last 12 months, would you say that on the whole, your health has been: 
 
 
 
 
 
 
 
 
 
(Please  the one box which applies to you) 
Excellent 
 
Very good 
 
Good 
 

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6. 
Do you now, or have you ever had: 
 
 
Diabetes: 
Yes 
 
No 
 
 
 
High blood pressure: 
Yes 
 
No 
 
 
 
 
 
 
 
 
 
 
Coeliac Disease 
Yes 
 
No 
 
 
 
 
 
 
 
 
 
 
Insomnia 
Yes 
 
No 
 
 
 
 
 
 
 
 
 
 
Sleep Apnoea 
Yes 
 
No 
 
 
 
 
 
 
 
 
 
 
Kidney disease 
Yes 
 
No 
 
 
 
 
 
 
 
 
 
 
Hyperkalaemia 
Yes 
 
No 
 
 
 
 
 
 
 
 
Gastrointestinal disorders 
Yes 
 
No 
 
 
 
 
 
 
 
 
Substance abuse or alcoholism 
Yes 
 
No 
 
 
 
 
 
 
 
 
Cardiovascular disease 
Yes 
 
No 
 
 
 
 
 
 
 
 
Clinical mental health disorder 
Yes 
 
No 
 
 
 
 
 
 
 
 
 
 
7. 
Has a doctor ever told you that you have had a heart attack? 
 
 
 
Yes 
 
No 
 

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8. 
Are you taking any routine medications? 
 
 
 
Yes 
 
No 
 
 
 
 
 
If yes, please provide details  
 
 
 
 
9. 
Are you taking any routine supplements? 
 
 
 
Yes 
 
No 
 
 
 
 
 
If yes, please provide details  
 
 
 
 
Would you be willing to stop these supplements throughout the 
study period? 
 
 
 
Yes 
 
No 
 
 
 
 
 
 
Lifestyle 
 
10. 
Do you work? 
 
 
 
Yes 
 
No 
 
 
 
 
 
If yes, please provide your occupation 
 
 
 
 
11. 
Do you hold any care responsibilities that require you to be awake 
through the night? 
 
 
 
Yes 
 
No 
 
 
 
 
 
12. 
Are you pregnant, planning pregnancy, breastfeeding or had a baby 
in the last 12-months? 

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Yes 
 
No 
 
 
13. 
Do you own a smart phone? 
 
 
 
Yes 
 
No 
 
 
If yes, please provide the brand name and the 
model 
 
 
 
 
14. 
Do you have any dietary preferences? 
 
 
 
 
 
Yes 
 
No 
 
 
 
 
 
 
 
 
 
Vegetarian 
 
 
 
 
 
Vegan 
 
 
 
 
 
Pescetarian 
 
 
 
 
 
Flexitarian 
 
 
 
 
 
Other  
 
 
 
 
 
 
 
 
Food and Drinks 
 
The following questions ask about some foods & drinks you might have during a ‘typical’ week, over 
the past month or so. Do not be concerned if some things you eat or drink are not mentioned.  
 
8. Please tick how often you eat at least ONE portion of the following foods & drinks: (a portion 
includes: a handful of grapes, an orange, a serving of carrots, a side salad, a slice of bread, a glass of 
pop). 
 

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(Please only put one tick, but answer EVERY line)  
 
Rarely 
or 
never 
Less 
than 1 
a 
Week 
Once a 
Week 
2-3 
times a 
Week 
4-6 
times a 
Week 
1-2 
times a 
Day 
3-4 
times a 
Day 
5+ a 
Day 
Fruit (tinned / fresh) 
 
 
 
 
 
 
 
 
Fruit juice (not cordial or 
squash) 
 
 
 
 
 
 
 
 
Salad (not garnish added 
to sandwiches) 
 
 
 
 
 
 
 
 
Vegetables (tinned / 
frozen / fresh, but not 
potatoes) 
 
 
 
 
 
 
 
 
Chips / fried potatoes 
 
 
 
 
 
 
 
 
Other potatoes (boiled, 
baked, mashed) 
 
 
 
 
 
 
 
 
Wholemeal bread, rice, 
pasta 
 
 
 
 
 
 
 
 
White bread, rice and 
pasta 
 
 
 
 
 
 
 
 
Red meat (pork, lamb, 
beef) 
 
 
 
 
 
 
 
 
Fish 
 
 
 
 
 
 
 
 
Chicken 
 
 
 
 
 
 
 
 
 
 
9. On average, how many portions of FRUIT do you eat a day?  
(examples include a handful of grapes, an orange, a glass of fruit juice, a handful of dried fruits). 
___________________ 
 

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10. On average, how many portions of VEGETABLES do you eat a day? (examples include: 3 heaped 
tablespoons of carrots, a side salad, 2 spears of broccoli).  
_____________________ 
 
11. What milk do you usually use or drink, such as in hot & cold drinks or on cereal? (including tea, 
coffee, hot milk, milk shakes, or on cereal) 
 
Whole / full-fat milk 
 
Semi-skimmed milk 
 
Skimmed milk 
 
Rarely/never use milk 
 
Other (please write its name) 
 
 
 
12. On average, how much alcohol do you drink over a complete seven day week? 
(One unit is a standard glass of wine, half a pint of beer or lager, a single measure of spirits, a 
measure of sherry) 
 
I rarely/never drink alcohol 
 
Less than 14 units 
 
Between 14 & 21 units 
 
More than 21 units 
 
 
 
13. 
Last week (or a week before that if you have been poorly or on holiday), how much exercise did 
you do, if any? 
 
 
(a) 
I didn’t do any exercise 
 
 
 
 
 
 
(b) 
I did some LIGHT exercise 
 
 

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This was fairly easy and I didn’t get out of breath (Eg. Gentle walking, playing bowls or snooker, light 
DIY/housework). 
 
I did this ________ times during the week. 
 
Each time I did this lasted about ___________ minutes 
 
AND / OR 
(c) 
I did some MODERATE exercise 
 
 
 
This made my breathing a little harder or made me sweat. (Eg fast walking, swimming, golf, heavy 
housework). 
 
I did this ________ times during the week. 
 
Each time I did this lasted about ___________ minutes 
 
AND / OR 
(d) 
I did some VIGOROUS exercise 
 
 
 
This made my breathing hard & made me sweat. (Eg running, squash, hard swimming, aerobics). 
 
I did this ________ times during the week. 
 
Each time I did this lasted about ___________ minutes 
 
 
 
14. 
Regarding smoking, are you? 
 
 
 
 
 
A current smoker 
 
 
 
 
 
 

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An ex-smoker 
 
When did you give up? 
 
Months 
 
 
 
I have never smoked 
more  
 
 
 
 
 
 
 
 
than 100 cigarettes   
 
 
 
 
 
 
 
STOP-Bang questionnaire for Sleep Apnoea (Chung et al., 2008) 
 
Height _____ inches/cm Weight _____ lb/kg 
 
Age _____ Male/Female BMI _____ 
 
Collar size of shirt: S, M, L, XL, or _____ inches/cm 
 
Neck circumference* _____ cm 
 
S  noring 
Do you snore loudly (louder than talking or loud enough to be heard through closed doors)? 
Yes | No 
T  ired 
Do you often feel tired, fatigued, or sleepy during daytime? 
Yes | No 
O  bserved 
Has anyone observed you stop breathing during your sleep? 
Yes | No 
Blood p  ressure 
Do you have or are you being treated for high blood pressure? 

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Yes | No 
* Neck circumference is measured by staff 
 
 
 
 
Thank You 
 
 
 

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Appendix 4. Participant Information Sheet on Urinary collection 
 
Background 
Urinary samples are a good indicator for mineral intake, as most minerals are not stored in the body 
but excreted out. This is why we ask for urine to be collected for the whole 24-hours, so we have a 
complete view of the whole day. This method is used routinely for national dietary surveys (25).  
 
Overview 
• 
The 24-hour period starts with the first early morning urine. Please discard this urine and record 
it as the “Start time”.   
• 
All urine passed after this will be collected, starting from the second morning urine passed of 
the 24-hour collection day, and ending with the first urine passed the following morning. 
• 
The collection day will always be the day before your clinic visit and one time point midline.  
 
Collection 
1. Upon passing your first urine of the day, please record the time point as the start of your study. 
2. To collect your first urine of the study, use the plastic jug provided and try to collect the whole 
urine stream.  
3. Open the lid on the 5L container and place the funnel in the neck. 
4. Carefully decant the urine into the larger container. 
5. If you are not at home when you need to collect your urine, please follow the same instructions 
as above, but instead you can decant your urine into the 2L container, to make carrying the 
sample around less arduous.  
6. Please keep your urine in a dark cool environment (explained in FAQs).  
 
 
Important information: 
• 
Transporting urine: When transporting any urine, please use the plastic bags and ensure 
that lids are tightly sealed so to avoid spillages.  
• 
If you are menstruating on the day of urinary collection, please seek advice from the study 
lead to find an appropriate collection day, contact details are at the end of this document.  
• 
Please ensure you fill out the urine collection form as it guides you, this information is 
essential for accurate processing.  
 
FAQs 

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• 
What happens if I forget a sample? This isn’t a natural process, so it’s normal to forget your 
need to urinate in the sample jug. But please try to be mindful during this period. Top tip is 
to take the sample on a weekend day when you’re pottering around the house and keep 
your sample jug in the bathroom as a reminder! 
• 
What happens if I spill some of my sample? Please record the event and try to estimate, 
where possible, how much you think was lost.  
• 
What happens if I leave my sample somewhere warm? Cooling the sample slows the growth 
of bacteria and stops it from interfering with the analysis.  
 
Please note, you will have a call with a study team member to run through this process, and we’ll be 
able to answer any questions you may have.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 5. 24-hour urine collection form 
Urine Collection Form 
 
Participant ID 
 
Urinary sample number 
 
(1/2/3) 
 
Start Date 
 
(Please only record the date from when you 
collect your first sample, which will be your 
second urination of the day) 
 
End Date 
 
 
Start time of 24hour urine 
collection: 
 
(Time after first urine of the day) 
 
Finish time of 24hour urine 
collection 
 
(First urine of the following day) 
 
 
Did you miss any collections? 
 
(If yes, please state how many collections 
you missed, and if possible, try to estimate 
the amount lost) 
 
Did you have any spillages?  
 
(If yes, please try to estimate the amount 
lost, e.g., 3-4 drops or 10mL from measuring 
jug) 
 

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Did you use any medications 
used during this time? 
 
(Please list all) 
 
Please only fill out the following for your midline measure. 
What is the weight of your 
empty 5L bottle? 
 
(Please record this before you fill up the 
bottle) 
 
 
What is the weight of your total 
24-hour sample?  
 
(Please give us the weigh to the nearest 
gram) 
 
 
What is the weight of your sub-
sample tube without any urine 
in it? 
 
(Please record this before you fill it up, 
ensure the lid is on for this measure and the 
for the end measure) 
 
 
What is the weight of your sub-
sample with urine in it?  
 
(Please ensure the lid is on for this measure) 
 
 
The below box is for staff to fill in only.  

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Is your 24-hour sample greater 
than 400mL?  
 
 
Research staff name and signature:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 6. Information with regards to Safety Reporting in Non-CTIMP Research 
 
Who 
When 
How 
To Whom 
SAE 
Chief 
Investigator 
Within 15 days of CI 
becoming aware of the 
event 
 
SAE Report form for Non-
CTIMPs, available from NRES 
website. 
Main REC with a copy 
to the sponsor 
Urgent Safety 
Measures  
Chief 
Investigator  
Immediately 
 
Within 3 days  
By phone 
 
Notice in writing setting out 
reasons for the urgent safety 
measures and the plan for 
future action. 
Main REC  
 
Main REC with a copy 
sent to the sponsor. 
The MREC will 
acknowledge this 
within 30 days of 
receipt.  
Progress 
Reports  
Chief 
Investigator  
Annually ( starting 12 
months after the date of 
favourable opinion) 
Annual Progress Report 
Form (non-CTIMPs) available 
from the NRES website 
Main REC with a copy 
to the sponsor 
Declaration of 
the conclusion 
or early 
termination of 
the study 
Chief 
Investigator  
Within 90 days 
(conclusion) 
 
Within 15 days (early 
termination) 
 
The end of study should 
be defined in the protocol 
End of Study Declaration 
form available from the 
NRES website 
Main REC with a copy 
to the sponsor  
Summary of 
final Report  
Chief 
Investigator 
Within one year of 
conclusion of the 
Research 
No Standard Format 
However, the following 
Information should be 
included:- 
Where the study has met its 
objectives, the main findings 
and arrangements for 
publication or dissemination 
Main REC with a copy 
to be sent to the 
sponsor 

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including feedback to 
participants 
 
 
 
 

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Appendix 7. Flow diagram, provided by Kings College London Research Governance Office, 
outlining Adverse Events definitions and procedures 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 8. Pittsburgh sleep quality index questionnaire 
 
Name: 
 
Date:  
 
Pittsburgh Sleep Quality Index (PSQI) 
Instructions: The following questions relate to your usual sleep habits during the past month only. Your answers 
should indicate the most accurate reply for the majority of days and nights in the past month. Please answer 
all questions. 
1. During the past month, what time have you usually gone to bed at night?  
 
2. During the past month, how long (in minutes) has it usually taken you to fall asleep each night?  
 
3. During the past month, what time have you usually gotten up in the morning?  
 
4. During the past month, how many hours of actual sleep did you get at night? (This may be different than the 
number of hours you spent in bed.)  
 
5. During the past month, how often have you had 
trouble sleeping because you… 
Not during 
the past 
month 
Less than 
once a 
week 
Once or 
twice a 
week 
Three or more 
times a week 
a. Cannot get to sleep within 30 minutes 
b. Wake up in the middle of the night or early 
morning 
c. Have to get up to use the bathroom 
d. Cannot breathe comfortably 
e. Cough or snore loudly 
f.  Feel too cold 
g. Feel too hot 
h. Have bad dreams 
i.  Have pain 
j.  Other reason(s), please describe: 
6. During the past month, how often have you 
taken medicine to help you sleep (prescribed or 
“over the counter”)? 
7. During the past month, how often have you had 
trouble staying awake while driving, eating meals, 
or engaging in social activity? 
No 
problem 
at all 
Only a 
very slight 
problem 
Somewhat 
of a 
problem 
A very big 
problem 
8. During the past month, how much of a problem 
has it been for you to keep up enough enthusiasm 
to get things done? 
Very 
good 
Fairly 
good 
Fairly 
bad 
Very 
bad 
9. During the past month, how would you rate 
your sleep quality overall? 

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Appendix 9. Advertisement Poster 
 
 
 
 

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Appendix 10. Advertisement Instagram post/Tweet 
“Do you want to help with cardiometabolic research by consuming carbs? 
@Kings College London is running a new 12-week dietary study and needs healthy 
volunteers! This study is free-living so you can take part from the comfort of your own 
home, with just 2 visits to Kings College London, near Waterloo station. If you’re interested, 
please contact the study team at starchy@kcl.ac.uk. #clinicaltrial #diet #nutritionalscience 
#starch” 
  
 
 

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Appendix 11. Advertisement Email 
Dear [NAME] 
  
I am writing to you to invite you to take part in a study in affiliation with the Kings College London 
titled:  
  
“STARchy staples: a randomised controlled trial on Cardiometabolic Health”. 
  
Can you help us understand how different starchy staples impact our cardiometabolic health? We are 
looking for healthy volunteers (40-80y) to take part in a research project. The aim of this study is to 
investigate if habitually consuming starchy staples in the evening meal, can improve one’s sleep 
quality, nocturnal blood sugars, arterial health, fasting blood profiles, blood pressure and other 
related parameters.  
 
Your participation will involve completing an online screening questionnaire, attending an 
introductory call, an induction and dietary consultation via videocall, and two clinic visits, as well as 
consuming starchy staples such as potatoes, pasta, rice, couscous, or bread alongside your evening 
meal for a total of 14-weeks, including a two-week study run-in to trial your suitability for this study. 
This study will be used to inform dietary advice on starchy staples in the prevention of chronic 
disease. 
  
We will offer you £100 renumeration and up to £10 travel reimbursement for each visit to Kings 
College London, Waterloo.  
  
Attached to this email is an information sheet where you can find all the details on the study on what 
will happen, why it is being conducted and your role in the research. Before you decide whether to 
take part, please take time to read the enclosed information sheet and take your time to decide.  
  
If you have any questions or would like further clarification and information about the study then 
please get in contact by emailing at starchy@kcl.ac.uk or calling on +44XXXXXX, and we will be happy 
to discuss with you.  
  
If you are interested in taking part, please reply to this email expressing your interest and we can 
arrange a date that suits you for our introductory call.  
 
Please note that participation is voluntary, so if you decide you would no longer like to participate, 
then you are free to drop out at any stage.   
  
Best wishes,  
Anya Klarner, ANutr | PhD student 
Department of Nutritional Sciences |  School of Life Course Sciences | Faculty of Life Sciences & 
Medicine 
King’s College London | Franklin Wilkins Building | 150 Stamford Street | SE1 9NH 

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Appendix 12. Gatekeeper Email 
Dear (University/Institution),  
RE: Advertisement of The STARCHy study (Ref XXXX) 
We are contacting you to request the opportunity to advertise our research study to members of 
your organisation. We have included a brief description of our study below for your consideration. 
We have also attached a more detailed proposal with explanation of rationale and what the study 
entails. The study has full ethical approval from the King’s College London Research Ethics 
Committee (HR/DP-22/23-35587).  
We would be very grateful if you would consider advertising our study in your organisations’ 
Newsletter/Bulletin. Alternatively, we are keen to advertise via poster/leaflets placed in institutions 
and will deliver some to your organisation if this is permitted.  
Below is a brief description of our study: 
“STARchy staples: a randomised controlled trial on Cardiometabolic Health- The STARCHy study”. 
Can you help us understand how different starchy staples impact our cardiometabolic health? We are 
looking for healthy volunteers (40-80y) to take part in a research project. The aim of this study is to 
investigate if habitually consuming different starchy staples in the evening meal, can improve 
glycaemic, blood and endothelial profiles, thereby reducing one’s risk for chronic diseases. You will be 
reimbursed with £100 upon completing the study.” 
If you require any further documentation from us for advertisement/regulatory purposes, please do 
not hesitate to contact us. 
We look forward to hearing from you.  
Best wishes,  
Anya Klarner