The RELISH Study: A Prospective Observational Study to Assess Compliance and Palatability of foRtifiEd Porridge Compared to Standard LIquid-baSed Oral Nutritional Supplementation in Hospitalised Older Adults With Malnutrition
Phase: NA
Conditions: Malnutrition
Sponsor: University Hospital Southampton NHS Foundation Trust

 
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This protocol has regard for the HRA guidance and order of content 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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FULL/LONG TITLE OF THE STUDY 
A prospective observational study to assess compliance and palatability of fortified porridge compared 
to standard liquid-based oral nutritional supplementation in hospitalised older adults with malnutrition 
 
SHORT STUDY TITLE / ACRONYM 
The RELISH study 
 
PROTOCOL VERSION NUMBER AND DATE 
Version 1.1 31/05/24 
RESEARCH REFERENCE NUMBERS 
 
IRAS Number: 316234 
  
 
SPONSORS Number: RHM 
MED1921 
 
 
FUNDERS Number: Internally 
funded via the UHS Commercial 
Team 
 
ClinicalTrials.Gov Number: 
Waiting for record to be approved 
and released 
 
 
 
 

 
 
 
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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory 
requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the investigation without the prior written 
consent of the Sponsor 
I also confirm that I will make the findings of the study publically available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned in this 
protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
Name (please print): 
...................................................................................................... 
 
 
Position: 
...................................................................................................... 
 
 
 
Chief Investigator: 
Signature:  
...................................................................................................... 
 
Date: 
31/05/2024 
Name: (please print): Dr Stephen Lim 
......................................................................................................
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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LIST of CONTENTS 
GENERAL INFORMATION 
Page No. 
HRA PROTOCOL COMPLIANCE DECLARATION  
i 
TITLE PAGE  
ii 
RESEARCH REFERENCE NUMBERS 
 
ii 
SIGNATURE PAGE 
iii 
LIST OF CONTENTS  
iv 
KEY STUDY CONTACTS 
v - vi 
STUDY SUMMARY 
vi - ix 
FUNDING 
 
ix  
ROLE OF SPONSOR AND FUNDER 
ix - x 
ROLES & RESPONSIBILITIES OF STUDY STEERING GROUPS AND INDIVIDUALS   
x - xi 
STUDY FLOW CHART 
 
xii 
SECTION  
1. BACKGROUND AND RATIONALE 
 
1 - 3 
2. RESEARCH QUESTION/AIM(S)  
3  
3. STUDY DESIGN/METHODS 
4 - 6 
4. STUDY SETTING 
6 
5. SAMPLE AND RECRUITMENT 
6 - 9 
6. ETHICAL AND REGULATORY COMPLIANCE 
9 - 13 
7. DISSEMINATION  POLICY 
13 - 14 
8. REFERENCES 
14 - 16 
9. APPENDICES 
17 - 120 
 
 

 
 
 
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KEY STUDY CONTACTS 
Chief Investigator 
Dr Stephen Lim 
Consultant Geriatrician 
Clinical Academic in Geriatric Medicine 
Academic Geriatric Medicine 
University of Southampton 
University Hospital Southampton NHS FT 
Tremona Road 
Southampton 
SO16 6YD  
 
Email: s.e.lim@soton.ac.uk 
Telephone: 02381206131 
Sponsor 
Ms Rachael Pulham 
Clinical Trial Project Manager 
R&D Department  
University Hospital Southampton NHS Foundation Trust 
Tremona Road  
Southampton  
SO16 6YD 
sponsor@uhs.nhs.uk 
Funder(s) 
University Hospital Southampton NHS Foundation Trust 
Commercial Team 
Email: commercial@uhs.nhs.uk; asa.thorpe@uhs.nhs.uk    
 
Key Protocol Contributors 
Dr Harnish Patel  
Consultant Geriatrician,  
University of Southampton,  
University Hospital Southampton NHS FT 
Southampton SO16 6YD 
Email: harnish.patel@uhs.nhs.uk 
Telephone:  
 
Rebecca Picton  
Lead Dietician in Geriatric Medicine 
Dietetics/Speech and Language therapy Department 
University Hospital Southampton NHS FT 
Southampton SO16 6YD 
Email: Rebecca.picton@uhs.nhs.uk  
Telephone: 023 8120 6072 
 
Dr Samantha Jane Meredith 
Research Fellow 
Academic Geriatric Medicine 
University of Southampton,  
University Hospital Southampton NHS FT 

 
 
 
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Southampton SO16 6YD 
Email: s.j.meredith@soton.ac.uk 
Telephone: 07825 104783 
 
Bethan Jenkins 
Acute Dietetic Lead 
Dietetics/Speech and Language therapy Department 
University Hospital Southampton NHS FT 
Southampton SO16 6YD 
Email: bethan.jenkins@uhs.nhs.uk   
 
Mrs Pamela Holloway 
Public patient representative 
Email: pamdouglas@ntlworld.com  
 
 
STUDY SUMMARY 
 
Study Title 
Compliance and palatability of fortified porridge compared to 
standard liquid-based oral nutritional supplementation in 
hospitalised older adults with malnutrition 
Internal ref. no. (or short title) 
ONS Compliance and Palatability  
Background 
22% of hospitalised older adults are estimated to be in a state 
of malnutrition. Malnutrition, also known as undernutrition, is a 
lack of nutritional intake leading to decreased fat free mass and 
diminished physiological functioning. Malnutrition impairs 
patient recovery, increasing hospital length of stay and 
escalating healthcare costs. Therefore, the identification and 
management of malnutrition is a vital patient-centred outcome 
to enhance older adult’s health and quality of life and to enable 
cost-effective treatment and care.   
 
A key method to support individualised nutritional care of 
hospital 
in-patients 
is 
the 
use 
of 
oral 
nutritional 
supplementation (ONS). ONS are energy and nutrient dense 
products designed to increase dietary intake when diet alone 
is insufficient to meet daily nutritional requirements. Overall, 
research suggests favourable impacts of ONS on nutritional 
status and healthcare costs, while the impact on functional 
outcomes and mortality are more controversial. A burgeoning 
evidence base attests to the importance of considering 
acceptability and compliance of ONS on adequate intake and 
thus effectiveness of ONS in practice. 
 
Patient compliance to ONS considers the relationship between 
the amount of ONS prescribed and the amount of ONS 
ingested and is important to maximise clinical and cost-
effectiveness. Palatability refers to the hedonic (i.e., 
pleasantness) evaluation of sensory factors, such as taste and 

 
 
 
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smell, leading to alterations in food or fluid consumption. 
Supplemental preference may be affected by a multitude of 
factors such as taste, colour, smell, after taste and texture. 
Typically, hospital patients are offered liquid based ONS (sip 
feeds). However, previous research has pinpointed that 56% 
of older adults on geriatric wards did not like sip feeds. Hence, 
exploration of compliance to different ONS formats is an 
important research direction to maximise malnourished older 
adult’s nutritional intake. 
 
Malnourished hospitalised older adults should be offered an 
improved range and provision of ONS to suit patient 
preferences and maximise intake. For instance, an attractive 
alternative strategy is the use of energy and protein-dense 
meals (via fortification) or snacks (supplementation), including 
fortified bread, protein-enriched main meals and between meal 
snacks, such as biscuits, yoghurt and ice cream. Yet this is an 
understudied area, with limited data investigating compliance 
to alternative ONS products compared to ready-made drinks in 
hospital, such as powdered ONS and snacks, or their clinical 
effectiveness. Therefore, the current study aimed to 
investigate the compliance and palatability of novel fortified 
porridge compared to traditional sip-feeds in malnourished 
hospitalised older adults.  
Research Question/Aim(s) 
 
1. What are the compliance rates (% intake) of fortified 
porridge compared to standard liquid based ONS in 
malnourished hospitalised older adults? 
2. What are the palatability ratings (e.g., taste) of fortified 
porridge compared to standard liquid based ONS in 
malnourished hospitalised older adults? 
3. What is the acceptability of fortified porridge compared 
to standard liquid based ONS in malnourished 
hospitalised older adults, including facilitators and 
barriers to their use on medical wards?  
Study Design & Methods 
A mixed methods randomised controlled crossover design will 
be conducted to determine compliance and palatability of 
fortified porridge in malnourished hospitalised older adults 
compared to a liquid-based control ONS. The acceptability of 
products will be assessed through qualitative interviews to 
explore patients and healthcare professionals’ experiences 
and views of using the nutritional supplements. Participants will 
be prescribed ONS twice per day for 4 days, in addition to 
normal meals, in a crossover design. The products will be 
offered in-between breakfast and lunch, and after dinner to 
reduce the detrimental long period of calorie absence 
experienced overnight. 
Study Participants 
Patients on UHS acute medical wards aged ≥65 years with 
medium-high risk of malnutrition (MUST score 1-4) and who 
are able to provide written consent will be invited to 
participate in the study.  

 
 
 
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Planned Size of Sample (if applicable) A sample size of 50 was chosen based upon guidance from 
previous literature investigating compliance and palatability of 
ONS. 
 
To explore acceptability, 15 interviews will be conducted 
among patients (N= 9) and health care professionals (N= 6) 
to share their thoughts on using the ONS products and to 
capture their views regarding implementation of ONS 
products on the wards.  
Outcomes  
Primary Outcome Measures: 
1. Compliance to ONS will be assessed by the study 
team via careful documentation of ONS leftovers at 2 
timepoints, including after lunch (for ONS given in the 
morning) and early morning the following day (for 
ONS given after dinner), to ensure enough time for 
consumption. Leftovers will be weighed (g) and 
documented. Compliance will be calculated as the 
percentage of the mean ONS consumed per day. 
Moreover, the mean intake of ONS energy (kcal/day) 
and protein (g/day) consumed per day will be 
calculated and an estimation of the percentage 
ingested. 
2. Palatability ratings, including appearance, smell, taste, 
sweetness, texture, thickness, aftertaste, mouth feel, 
and overall likability will be assessed with a 7-point 
hedonic Likert scale (7 = definitely like, 6 = moderately 
like, 5 = mildly like, 4 = neither like nor dislike, 3 = 
mildly dislike, 2 = moderately dislike, 1 = definitely 
dislike). 
Secondary Outcome Measures: 
1. Total energy intake will be assessed through 
completion of patient food charts, including estimated 
proportion of meals consumed.  
2. Acceptability of ONS products will be explored with 
semi-structured interviews. The semi-structured 
interviews will consist of several key open-ended 
questions that help define the areas explored but 
allow the interviewer or interviewee to expand and 
diverge with the aim of pursuing or developing an idea 
with more depth. 
Patient and Public Involvement 
9 patients (5 male) aged 71-99 years on geriatric wards at UHS 
completed a pilot palatability survey to explore Adams Vital 
Nutrition Build & Restore fortified porridge. The majority of 
patients chose chocolate porridge over golden syrup (N= 8). 
Palatability was measured on a 10-point Likert scale (e.g., 0, 
not tasty at all to 10, very tasty). Patients had a mean taste 
rating of 7.22, consistency of 7.14 and appearance of 7.33. 

 
 
 
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Three patients ate the whole portion, 3 ate half, and 3 ate less 
than half of the portion. Patients were also asked at what time 
of day they would prefer to eat the product. Four patients 
preferred to eat the product for breakfast, 1 as a mid-afternoon 
snack, 2 preferred the product in the evening, and 2 patients 
would eat the product at any time of day. This pilot helped to 
inform patient facing materials, data collection templates, and 
gave early indication regarding the palatability of the trial 
product. 
    
To help with further development of ONS flavours, a PPI 
survey was distributed to 25 older adults (age 86.23 ± 5.93 
years; 56% female; 92% White British, 8% Indian) on UHS 
geriatric medical wards. We assessed patients’ likability for 
porridge and porridge flavours using a 7-point Likert scale from 
‘definitely like’ (7) to ‘definitely dislike’ (1). Analyses showed a 
median likability rating of 5 ‘mildly like’ (IQR 3-6) for porridge 
with 60% circling a score in the ‘like’ section of the scale, 8% 
neither like nor dislike, and 32% circling scores in the ‘dislike’ 
section. Three participants explained they have difficulty 
swallowing, so even though porridge was not their favourite 
snack they would eat it as they can only manage soft foods. 
When asked ‘what is your favourite type of snack to eat 
between meals?’ most preferred fruit (n = 7, 28%), or biscuits 
(n = 6, 24%), and 16% preferred not to eat any snacks.  
 
The top three flavours of porridge that participants were most 
likely to eat were golden syrup (44% like, 8% neither like nor 
dislike, 48% dislike), strawberries and cream (32% like, 8% 
neither like nor dislike, 60% dislike), and apple and cinnamon 
(32% like, 8% neither like nor dislike, 60% dislike). Participants 
were asked ‘when you make porridge for yourself what flavour 
do you prefer to eat?’ Participants preferred neutral porridge 
with sugar, strawberry jam, or golden syrup added (n = 18, 
72%).  
 
1 public contributor provided input into this study proposal. 
They will be invited to join the study management group and 
be involved from development to dissemination of study 
findings.  
Dissemination 
Results will be shared with commissioning services, NHS staff, 
and service users, supported by our PPI partners. Results will 
also be shared via publication and conference presentations. 
 
Planned Study Period 
Start Date: 1st April 2024 
End Date:  31st October 2024 
Years: 0 Months: 7 Days: 0 
 
 

 
 
 
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FUNDING AND SUPPORT IN KIND 
FUNDER(S) 
(Names and contact details of ALL organisations 
providing funding and/or support in kind for this 
study) 
FINANCIAL AND NON FINANCIALSUPPORT 
GIVEN 
University Hospital Southampton NHS 
Foundation Trust 
Commercial Team, Southampton General 
Hospital 
Southampton 
SO16 6YD 
commercial@uhs.nhs.uk 
asa.thorpe@uhs.nhs.uk  
Funding secured: £3,881.28 
Duration:  7 months 
 
 
ROLE OF STUDY SPONSOR AND FUNDER 
The sponsor will take overall responsibility for proportionate, effective arrangements being in place to 
set up, run and report the research project. The study sponsor will review research protocols and 
study documents to ensure they meet regulatory requirements. The sponsor will also review IRAS 
forms before submission for ethical review and will monitor the conduct of the study, including any 
amendments that need to be made. The sponsor will review annual progress reports and will be 
involved in the ‘close out’ of the study.  
 
Funding for this study is provided through the University Hospital Southampton NHS FT commercial 
team. The study funder reviewed the protocol before funding was secured to ensure the proposed 
project aligned with research portfolios within UHS clinical divisions, and/or the UHS/UoS research 
infrastructure. The funder has provided funding to cover the costs of the study, detailed below:  
 
Summary of costs 
Research Fellow  
 
 
£3,881.28 
 
Total  
 
 
 
£3,881.28 
 
ROLES AND RESPONSIBILITIES OF STUDY MANAGEMENT COMMITEES/GROUPS & 
INDIVIDUALS 
 
The Chief Investigator (CI), Dr Stephen Lim is responsible for the overall conduct of the study. He has 
the primary responsibilities of planning and managing the project, ensuring that the project progresses 
according to schedule.  
 
The Principle Investigator (PI), Dr Samantha Jane Meredith, will assist the CI in participant 
recruitment, data collection and data entry. Weekly meetings will be held with the CI and the research 
fellow to discuss the day to day running of the study. Monthly project management meetings will be 
held with the CI, RF and PPI lead to discuss the progress of the study and to monitor the conduct of 
the study. 
 
Dr Harnish Patel is a Consultant Geriatrician with extensive experience in the clinical management of 
older people both within the acute and rehabilitation settings. He has a specialist interest in the 
recognition and management of frailty and is developing pathways within Southampton General 

 
 
 
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Hospital. His expertise will be key to the delivery of a robust nutrition intervention. His experience in 
conducting trials will ensure that the study will be conducted to a high standard. 
 
Rebecca Picton is the lead dietitian for medicine for older people at University Hospital Southampton. 
Her expertise will support the development of a safe and effective ONS trial, including help in the 
steering of suitable ONS products used in the trial and appropriate for patient needs.  
 
 
Pamela Holloway is the lead PPI representative involved in the management of the study from 
development to dissemination of study findings.  
 
PROTOCOL CONTRIBUTORS 
The current protocol has been developed and adapted from early pilot work, steering study 
procedures, and through consultation with geriatric consultants and lead dieticians at UHS. Public 
representatives have been involved in the design of the study and will critique any patient-facing 
resources, such as participant information sheets, consent forms and interview schedules.  
 
The study sponsor (UHS) and funders were not directly involved in the design of this study. They will 
review research protocols and study documents to ensure they meet regulatory requirements. This 
provides the R&D Office with information on the considerations which have been made in the 
development of the protocol in a number of areas to help assess the level of risk to the Trust and how 
this can be mitigated. The sponsor will also review IRAS forms before submission for ethical review 
and will monitor the conduct of the study, including any amendments that need to be made. The 
sponsor will review annual progress reports and will be involved in the ‘close out’ of the study.  
 
The study funder reviewed the protocol before funding was secured in order to ensure the proposed 
project aligned with research portfolios within UHS clinical divisions, and/or the UHS/UoS research 
infrastructure.  
 
KEY WORDS:  
Malnutrition; older adults; oral nutritional supplement; 
compliance; palatability  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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STUDY FLOW CHART (Figure 1) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Malnourished older adults on acute medical 
and orthogeriatrics ward identified by the 
clinical care team 
Interested participants approached by 
research team to complete informed 
consent 
Completion of baseline questionnaires 
Randomisation to ONS sequence 
ONS Testing  
1 – 4 days  
Crossover design 
   
Assess palatability morning of day 1 and 3 
Assess compliance to ONS daily 
Completion of daily food diary 
Conduct semi-structured interview 
Completion of 2-day food diary (baseline 
total energy intake) 

 
 
 
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STUDY PROTOCOL 
Compliance and palatability of fortified porridge compared to standard liquid-based ONS in 
hospitalised older adults with malnutrition. 
 
1 
BACKGROUND AND RATIONALE 
Adequate nutritional intake is an important lifestyle factor and clinical consideration to maintain and 
maximise health and well-being in older people [1]. However, 1.3 million older people are 
malnourished in the UK, and 22% of hospitalised older adults are estimated to experience malnutrition 
[2, 3]. Malnutrition, also known as undernutrition, is defined as, “a state resulting from lack of uptake or 
intake of nutrition leading to altered body composition (decreased fat free mass) and body cell mass 
leading to diminished physical and mental function and impaired clinical outcome from disease” [4]. 
Malnutrition impairs patient recovery, increasing hospital length of stay and escalating healthcare 
costs. Indeed, the estimated health and social care expenditure associated with malnutrition in 
England was £19.6 billion in 2011-2012 and treating patients with malnutrition was over four times 
more costly than managing those without malnutrition [3, 5]. Moreover, malnutrition is a key 
contributing factor in the aetiology of sarcopenia and frailty and increases risk of morbidity and 
mortality [6-8]. Considering the adverse clinical outcomes associated with malnutrition, the 
identification and management of malnutrition is a vital patient-centred outcome to enhance older 
adult’s health and quality of life and to enable cost-effective treatment and care.   
  
A range of factors could contribute to low dietary intakes and malnutrition of hospital in-patients, 
including acute, or chronic medical conditions, side effects of pharmacological treatment, cognitive 
impairment, lack of help at mealtimes, and inadequate energy and protein intake from poor hospital 
food menus [9-11]. Older adults may also have compromised appetite regulation - an anorexia of 
ageing [12]. Hence, clinicians need to consider optimising methods to support individualised nutritional 
care of hospital in-patients. One such method is the use of oral nutritional supplementation (ONS). 
ONS are energy and nutrient dense products designed to increase dietary intake when diet alone is 
insufficient to meet daily nutritional requirements [1]. There are a multitude of ONS options, including 
flavours, formats (e.g., liquid, powder), types (e.g., high protein, vegan) energy densities, and volumes 
[1]. According to expert consensus, ONS should contain both micro and macronutrients and provide at 
least 400 kcal and a minimum of 30 g of protein per day to improve nutritional status, lower the risk of 
complications and readmission, and to decrease the risk of functional decline after discharge [11].  
 
Overall, research suggests favourable impacts of ONS on nutritional status and healthcare costs, 
while the impact on functional outcomes and mortality are more controversial [13-15]. In a Cochrane 
systematic review (62 trials; 10,187 participants), ONS typically in the form of commercial sip feeds 
improved weight change (2.2% increase) and reduced risk of complications for hospitalised older 
adults [14]. Few trials in the review indicated any functional benefit, no overall significant reductions in 
mortality, and limited evidence to suggest improvements in length of hospital stay when using ONS. 
Nevertheless, studies in which older adults were defined as undernourished showed statistically 
significant effects of ONS on reducing mortality [14]. Similarly, a systematic review and meta-analysis 
(36 trials; 3790 participants) investigating the effects of high protein ONS (>20% energy from protein) 
on clinical outcomes across settings and patient groups indicated significant reductions in 
complications, increased intake of protein and energy and improved weight [13]. Additionally, this 
review found reduced readmissions to hospital and improved grip strength in older adults using high 
protein ONS. Other research also corroborates the significant reductions in hospital readmissions in 
older patient groups using ONS [15, 16]. Therefore, it is not surprising that the clinical impacts of ONS 
have subsequent economic implications for healthcare, promoting cost savings in hospital settings and 
improved cost effectiveness, such as patients gaining quality adjusted life years [3, 17]. In a 
systematic review, 12 out of 14 trials comparing ONS with standard care demonstrated a significant 

 
 
 
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mean cost saving of 12.2%, and these savings were associated with significantly improved outcomes, 
such as 13% reduction in hospital stay [3]. Despite the myriad benefits of ONS alluded to above, a 
recent overview of systematic reviews and meta-analyses found discordance in the impact of ONS on 
patient outcomes potentially arising from heterogeneity of study designs, methodological rigour, 
differences in clinical background of patients and the etiological basis of malnutrition [18]. In addition, 
a burgeoning evidence base attests to the importance of considering acceptability and compliance of 
ONS on adequate intake and thus effectiveness of ONS in practice [19-23].      
 
Patient compliance to ONS considers the relationship between the amount of ONS prescribed and the 
amount of ONS ingested and is important to maximise clinical and cost-effectiveness. There are 
numerous factors that may influence compliance including type, variety, volume, energy-density, 
duration and timing of supplementation and whether any instruction, or assistance has been given 
[11]. The European Society for Clinical Nutrition and Metabolism (ESPEN) recommend that 
compliance should be assessed regularly when ONS are offered to older people with malnutrition and 
the form of ONS should be adapted to suit patient’s taste and eating capacities [1]. Higher energy 
density ONS appear to have better compliance rates than lower energy density ONS, possibly due to 
smaller volumes needing to be consumed [22, 24]. Typically, research has investigated the 
compliance of ready-made multi-nutrient liquids in older patient groups and has found a mean 
compliance with ONS of 67% in hospital, 81% in the community and an overall compliance of 78.8% 
across healthcare settings [22]. In other research, older hospitalised patient’s compliance with ONS 
(sip feeds) was low (37%) on geriatric wards [20]. Wastage of ONS in older hospitalised patients (n = 
22) over a 24-hour period incurred a wasted cost of £50.12, estimated as a net loss of £18, 294 per 
year [20]. The greatest wastage was seen in patients that disliked the taste of ONS (72%), indicating 
that poor palatability is an important barrier to compliance and should be considered when prescribing 
ONS. 
 
Palatability refers to the hedonic (i.e., pleasantness) evaluation of sensory factors, such as taste and 
smell, leading to alterations in food or fluid consumption [25]. Supplemental preference may be 
affected by a multitude of factors such as taste, colour, smell, after taste and texture. Moreover, 
continual single use of a supplement can result in monotony and taste fatigue leading to reduced 
intake [26]. Typically, hospital patients are offered liquid based ONS (sip feeds). However, previous 
research has pinpointed that 56% of older adults on geriatric wards did not like sip feeds [20]. Hence, 
exploration of compliance to different ONS formats is an important research direction to maximise 
malnourished older adult’s nutritional intake. Most research has investigated palatability, acceptability, 
and compliance of liquid type ONS indicating improved intake of lower thickness supplements [27], 
low volume, high energy and protein dense products [23, 24], and vanilla, coffee and strawberry milk-
based supplements [19]. Factors reducing compliance include build-up of a mouthcoating from sip 
feeds [28, 29], abdominal bloating [19], alterations in mouthfeel when wearing dentures and changes 
in flavour perceptions depending upon medication status [30].  
 
Malnourished hospitalised older adults should be offered an improved range and provision of ONS to 
suit patient preferences and maximise intake. For instance, an attractive alternative strategy is the use 
of energy and protein-dense meals (via fortification) or snacks (supplementation), including fortified 
bread, protein-enriched main meals and between meal snacks, such as biscuits, yoghurt and ice 
cream [31]. In a systematic review (546 patients, mean age 60-83 years), Mills and colleagues [31] 
concluded that compared with usual nutritional care, energy- and protein based fortification and 
supplementation could be employed as an effective, well-tolerated and cost-effective intervention to 
improve dietary intake amongst older inpatients, especially when standard ONS were not tolerated. 
Similarly, Taib and colleagues [32] investigated the acceptability and intake of an ice cream ONS (240 
kcal/per portion) over 3 days in malnourished fracture patients (median 75 years). Compliance to the 
ice cream ONS was good (77%) and average daily energy intake (1006 kcal/day) was 41% higher 

 
 
 
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compared to baseline nutritional survey among patients. This research suggests that alternative ONS 
products are feasible in hospitalised malnourished older adults. Yet this is an understudied area, with 
limited data investigating compliance to alternative ONS products compared to ready-made drinks in 
hospital, such as powdered ONS and snacks, or their clinical effectiveness.  
 
The ESPEN recommend, “When offered to an older person with malnutrition or at risk of malnutrition, 
compliance in ONS consumption shall be regularly assessed. Type, flavour, texture and time of 
consumption shall be adapted to the patient's taste and eating capacities.” [1]. In keeping with these 
recommendations, ONS variations according to flavours and categories need to be considered to 
improve patients’ compliance. Moreover, considering the detrimental consequences of malnutrition it is 
vital that hospitalised older people have access to optimum nutritional care packages, including 
palatable and acceptable ONS to enhance compliance, energy intake and maximise ONS 
effectiveness and clinical outcomes. Therefore, the aim of the current study is to investigate the 
compliance and palatability of fortified porridge compared to standard liquid based ONS, and to 
explore their acceptability on acute medical wards.   
 
2 
RESEARCH QUESTION/AIM(S) 
This study aims to investigate the compliance and palatability of fortified porridge, containing high 
energy and protein content, to explore product acceptability in malnourished hospitalised older adults.  
 
2.1 
Objectives 
 
The specific objectives include:  
• 
To determine patient compliance to fortified porridge compared to standard liquid based ONS 
assessed through measurement of product intake (%).  
• 
To examine the palatability of fortified porridge compared to standard liquid based ONS, 
including assessment of taste, flavour, and likeability. 
• 
To assess the acceptability of product use on acute medical wards through qualitative semi-
structured interviews with patients and healthcare professionals.  
 
2.2 
Outcome 
 
Exploration of the compliance, palatability, and acceptability of the ONS product will help to determine 
whether the product is appropriate for further evaluation in future research, to determine sample sizes 
for a controlled trial to investigate clinical outcomes of ONS and to assess whether the ideas and 
findings can be shaped to be relevant and sustainable. The study will also help to determine suitability 
of the product for use in UHS and for a larger roll out of the product across Wessex. 
 
Through collaborations between University of Southampton, University Hospital Southampton and 
Adams Vital Nutrition Ltd. the anticipated impacts include: 
 
• 
Explore the usability of additional ONS products to facilitate management of malnutrition in 
patient’s at UHS.  
• 
Lay a foundation for future randomised clinical trials.  
• 
Dissemination of our research findings through scientific and lay platforms to encourage 
implementation in other settings. 
• 
Improved nutrition support for older adults with malnutrition with potential benefit in health 
outcomes. 

 
 
 
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3 
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS 
 
Study Design 
A mixed methods randomised controlled crossover design will be conducted to determine compliance 
and palatability of fortified porridge in malnourished hospitalised older adults. A crossover design was 
chosen to account for heterogeneity in an older patient population (e.g., differences in disease states 
and oral sensory perceptions), in which participants will act as their own controls to better compare 
palatability of products. This study will be conducted at University Hospital Southampton (UHS) NHS 
Foundation Trust on geriatric acute medical wards comparing intake and palatability of ‘build and 
restore’ fortified porridge (treatment) and standard liquid based ONS (control) in a repeated measures 
crossover design. The acceptability of products will be assessed through qualitative interviews to 
explore patients and healthcare professionals’ experiences and views of using the different nutritional 
supplements.    
 
Intervention 
Participants will be prescribed ONS twice per day for 4 days, in addition to normal meals, in a 
crossover design. Two ONS products (Table 1) will be tested for palatability and compliance including 
a new fortified porridge (treatment), and standard liquid-based ONS (control). Each ONS product will 
be tested over 2 days in a randomised crossover sequence (Figure 1). The products will be offered 
twice per day, in-between breakfast and lunch, and after dinner to reduce the detrimental long period 
of calorie absence experienced overnight [33]. The fortified porridge (treatment) is powdered and 
mixed with 100 ml boiling water in a carton with a choice of 4 flavours including golden syrup, apple 
and cinnamon, strawberries and cream, and bananas and custard. The liquid-based ONS (control) are 
ready-to-drink milkshakes. Participants will be offered the ONS in a screw-topped plastic bottle, and 
a choice from a variety of flavours (e.g., vanilla, strawberry, chocolate, banana, mocha, neutral, 
berries). ONS products will be prepared and distributed to participants by health care professionals 
working on the wards. 
 
Table 1. ONS Product Information (see appendices for full product specification) 
Group 
Treatment  
Control 
Name 
Vital Daily High Protein 
Oats (Adams Vital 
Nutrition Ltd.) 
Anonymous readymade 
drink supplement 
Description 
Fortified ‘build and 
restore’ porridge ONS 
Standard liquid-based 
ONS 
Weight (g) 
157 
125  
Energy (kcal) 
230 
306 
Protein (g) 
15 
18.3 
 
 
Data Collection 
Participant Characteristics  
Participant characteristics including age, domicile status, marital status, care provision, usual 
residence, frailty (PRISMA-7), sarcopenia (SARC-F), and appetite (SNAQ) will be assessed at 
baseline. Moreover, participants C-reactive protein [34] and National Early Warning Score [35] will be 

 
 
 
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recorded as markers of acute illness (recorded as part of standard care), a potential mediator of older 
adults’ appetite [36]. 
 
Appetite will be measured using the Simplified Nutritional Appetite Questionnaire (SNAQ) [37], which 
has been validated to predict weight loss in community dwelling older adults and used to predict poor 
health outcomes in hospitalised older people [37-39]. SNAQ is a four-item tool comprising items 1, 2, 4 
and 6 of the CNAQ, assessing appetite, satiety, taste of food and number of meals per day 
respectively. SNAQ has a maximum score of 20, with a score of ≤14 indicating poor appetite. 
 
The Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) 
questionnaire will be used as a measure to assess for sarcopenia [40]. It comprises five components: 
strength, assistance in walking, rise from a chair, climbing stairs and falls. The scores range from 0 to 
10, with a score of equal to or greater than four being predictive of sarcopenia and poor outcome.  
 
Program of Research to Integrate Services for the Maintenance of Autonomy (PRISMA-7) screening 
tool will be used to characterise participants’ frailty status [41]. The questionnaire contains seven items 
with a positive score of three or more indicating frailty. The PRISMA-7 tool has been shown to have 
high accuracy in identifying frail older adults in the community setting [42]. 
 
Primary Outcome Measures 
Primary outcome measures will include compliance to ONS and palatability.  
 
Compliance: Compliance to ONS will be assessed by the study team via careful documentation of 
ONS leftovers at 2 timepoints, including after lunch (for ONS given in the morning) and early morning 
the following day (for ONS given after dinner), to ensure enough time for consumption. Leftovers will 
be weighed (g) using weighing scales (Seca Model 875 digital weighing scale) and documented by the 
research team. Compliance will be calculated as the percentage of the mean ONS consumed per day. 
Moreover, the mean intake of ONS energy (kcal/day) and protein (g/day) consumed per day will be 
calculated and an estimation of the percentage ingested.     
 
Palatability: Palatability ratings, including appearance, smell, taste, sweetness, texture, thickness, 
aftertaste, mouth feel, and overall likability will be assessed with a 7-point hedonic Likert scale (7 = 
definitely like, 6 = moderately like, 5 = mildly like, 4 = neither like nor dislike, 3 = mildly dislike, 2 = 
moderately dislike, 1 = definitely dislike). Hedonic scales have been used to assess palatability of 
ONS supplements across population groups [24, 32, 43] and have good reliability [44]. Palatability 
ratings will be completed by participants on initial introduction of each ONS at a standardised time of 
day (i.e., morning ONS on day 1 and 3) (Figure 2).   
 
Outcome measures will be collected by the PI (SM) and recorded on paper data collection sheets (see 
appendix), which will be stored securely in a locked filing cabinet in a secure key card access research 
office at UHS. Data will be double entered into an excel spreadsheet and statistical software (SPSS 
v.28) on a secure password protected University computer. Only the CI, PI and University regulatory 
authorities will have access to the data.   
. 
Secondary Outcomes Measures  
Secondary outcome measures will include acceptability of the ONS products and total caloric intake. 
 
Total caloric intake: Existing literature suggested that the effectiveness of ONS in improving energy 
intake can sometimes be compromised by the partial displacement of normal meals [45]. That is, 
despite compliance to ONS, total caloric intake might not be augmented by ONS through a potential 
decrease of habitual food intake. Therefore, total energy intake will be assessed through completion of 

 
 
 
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patient food charts, including estimated proportion of meals consumed. Food charts are a part of 
patients’ standard care and will be completed by the nursing team. Patient completed food diaries 
have been reported as a valid method to measure energy intake in hospitalised older adults, in which 
the food diary predicted within ±17% weighted energy intakes in 70% of individuals [46]. Energy intake 
(kcal) will be calculated from these diaries via nutritional data supplied by hospital catering (Serco). 
The food diary will be completed 2 days before the start of testing to estimate normal total energy 
intake, and then will be completed daily during the 4-day testing period.  
 
Acceptability: Acceptability of ONS products will be explored with semi-structured interviews. The 
semi-structured interviews will consist of several key open-ended questions that will help define the 
areas explored but allow the interviewer or interviewee to expand and diverge with the aim of pursuing 
or developing an idea with more depth. The interviews will seek to explore the views of hospitalised 
older adults and healthcare professionals working on geriatric medical wards, exploring the 
acceptability of the ONS products. The interviews will be audio-recorded for data collection purposes. 
Interviews with staff will take place one-to-one with the research assistant either in a private office 
space within UHS in-person, or remotely via telephone, or Microsoft Teams (depending on participant 
preference). Patients will be interviewed following completion of 4 days of ONS intervention at 
bedside, or in a private room at UHS, depending on personal preference.  
 
Data Analysis 
Quantitative data analysis 
Data collected will be double entered into a secured database for analysis. Statistical analysis will be 
conducted using the statistical software SPSS. Descriptive statistics -median (IQR); mean (SD); 
number (%) – will be used to analyse ONS ingested (%), intake of energy (kcal/day), intake of protein 
(g/day), and palatability Likert scores. Palatability Likert scores will be categorised into positive, neutral 
and negative scores and presented in bar charts to illustrate comparisons of each ONS product [47]. 
Compliance rates will be split into comparable groups with low, medium and high compliance 
categorised as ≤ 30%, 31-79%, and ≥ 80%, respectively, and presented in bar charts. Normality tests, 
including skewness and kurtosis, will be conducted to determine suitable statistical analyses for 
measures (i.e., non-parametric vs. parametric tests). Primary outcome measures will be compared 
between groups (treatment vs. control) using a repeated measures t-test, or Wilcoxon test, depending 
upon normality. Total daily energy intake (kcal) will be compared between ONS groups and to control 
(i.e., before testing) with a repeated measures ANOVA with Bonferroni correction to assess the impact 
of ONS on normal meal intake.  
 
Qualitative data analysis 
Interviews will be transcribed verbatim and analysed using reflexive thematic analysis (TA) [48]. TA is 
a method for identifying, analysing and reporting patterns or themes within data and is widely used in 
qualitative research. There are six phases in the process of conducting TA: Phase 1 – familiarising 
with the data, Phase 2 – generating initial codes, Phase 3 – searching for themes, Phase 4 – 
reviewing themes, Phase 5 – defining and naming themes, and Phase 6 – producing the report. 
Analysis of qualitative data will be conducted using either Microsoft Word, or with the help of NVIVO, 
depending on the amount of data collected. Transcribed text will be read and coded separately and 
then together by two researchers. The codes will be analysed to generate concepts and ideas to 
determine the acceptability of the intervention, and to identify facilitators and barriers to the 
implementation process. The codes act as tags or labels to help catalogue key concepts embedded 
within the raw data. From the codes, themes will be developed to reflect the views and experiences of 
the patients and healthcare professionals regarding the intake and use of ONS products in hospital.  
 

 
 
 
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4 
STUDY SETTING 
This is a single-centre study taking place at University Hospital Southampton NHS Foundation Trust. 
Patients with malnutrition will be identified and recruited from acute medical wards at UHS.    
 
5 
SAMPLE AND RECRUITMENT 
5.1  
Eligibility Criteria 
Older adults with malnutrition and staff on acute medical wards in UHS will be invited to participate in 
this study (see details below). 
 
5.1.1 Inclusion criteria  
Patients 
• 
Older adults ≥65 years  
• 
Patients on UHS acute medical wards 
• 
Medium-high risk of malnutrition (MUST score 1-4) 
• 
Able to provide written consent  
 
Health Professionals (interviews) 
• 
Working at UHS on the wards receiving the ONS intervention 
• 
Able to provide written consent 
 
5.1.2 Exclusion criteria  
• 
Patients that have used ONS in previous month 
• 
Receiving enteral or parental nutrition 
• 
Patients with a MUST score >4 (severely malnourished)   
• 
Patients with a BMI ≤15 
• 
Patients with chronic liver disease, renal failure, dysphagia 
• 
Patients who have had major surgery within the preceding month 
• 
Patients with a terminal illness 
• 
Patients receiving end of life care 
• 
Patients unable to eat by mouth (Nil By Mouth [NBM])  
• 
Patients who require alternative ONS as advised by dietetic support 
 
5.2  
Sampling 
 
Participants will be recruited from UHS using purposive sampling techniques (detailed below).  
 
5.2.1  Size of sample 
A sample size of 50 was chosen based upon guidance from previous literature investigating 
compliance and palatability of ONS [22, 29]. In a systematic review of 49 studies assessing ONS 
compliance, studies included 1-4 groups (median 2) with a median of 30 (interquartile range 23-41) 
participants in each group [22]. In the current study a repeated measures two tailed t-test will be 
applied to compare compliance and palatability between 2 conditions (treatment vs. control).  

 
 
 
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To explore acceptability, 10-15 interviews will be conducted among patients (N= 7-9) and health care 
professionals (N= 3-6) to share their thoughts on using the ONS products and to capture their views 
regarding implementation of ONS products on the wards.  
 
5.2.2  Sampling technique 
Older adults admitted to acute medical and orthogeriatric wards, who meet the eligibility criteria, will be 
recruited to the study. Purposive sampling will be used to recruit participants for interview, including a 
representative age range, ethnicity, and inclusion of a range of staff roles, including nurses (N= 2), 
health care assistants (N= 1), meal-time co-ordinators (N= 1), and doctors (N= 2).  
 
5.3 
 Recruitment 
Eligible patients will be identified and approached initially by their clinical care team before being 
approached by the research team (details below). Eligible healthcare professionals will be approached 
directly by the research team.  
 
5.3.1 Sample identification 
Malnourished older adults on UHS acute medical wards will be invited to participate in the study by a 
clinician (Dr Stephen Lim), assisted by a research assistant. Research staff will liaise closely with the 
patient’s clinical care team to identify patients that are eligible to participate in the study, based upon 
screening and inclusion criteria. Invited patients will be given a participant information sheet and time 
to ask any questions and discuss what is involved in the study.  
 
Screening checks to determine patient suitability to participate in the study will include the Malnutrition 
Universal Screening Tool (MUST). The MUST is a screening tool to identify adults who are 
malnourished, at risk of malnutrition, or obese through the assessment of weight status (BMI), change 
in weight, and the presence of an acute disease resulting in no dietary intake for more than 5 days 
[49]. A BMI (kg/m2) of >20 scores 0, 18.5-20 scores 1, and <18.5 scores 2 on the tool. Unplanned 
weight loss in past 3-6 months (%) of <5 scores 0, 5-10 scores 1, and >10 scores 2 on the tool. If the 
patient is acutely ill and there has been or is likely to be no nutritional intake for >5 days an additional 
score of 2 is applied. These three independent scores are then added, and participants are 
categorised into low (score 0), medium (score 1), or high risk (score ≥2) of malnutrition. The MUST is 
valid, reliable and easy to use, and can be applied across patient groups [13, 49-51]. 
 
Eligible participants will then complete an informed consent form and baseline questionnaires. 
 
Eligible staff will be approached directly by the research team. Interested staff will be given a 
participant information sheet to help them fully consider participation in the research.  
 
5.3.2 Consent 
The clinical care team will inform the research team of any interested patients. Interested participants will 
then be approached by the research team to explain the study in more depth and given a participant 
information sheet. Written consent will be obtained for older adults who are keen to participate in the 
study. 

 
 
 
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Participants will be given up to 2 days to decide if they would like to volunteer in the study. This will give 
participants time to consider their involvement in the study, to discuss the study with family and to ask any 
questions, while also enabling recruitment for the study before patients are discharged. All members of 
the study team are adequately trained in Good Clinical Practice (GCP) and have experience taking 
informed consent in previous research.  
 
Following distribution of participant information sheets, staff will be given a week to decide if they 
would like to participate in the study. This time will allow them to fully consider participating in the 
study and to ask any questions they may have. If they are interested in volunteering to be interviewed, 
they will complete written informed consent.  
 
5.4 Randomisation Procedure 
Once participants have completed informed consent each participant will be randomised in a 
crossover procedure to groups using a computer-generated randomization tool, ‘Research 
Randomizer’ [52], to minimise sequence effects and bias (Figure 2). Patients will be allocated to one 
of two sequences at random in a 1:1 allocation to eliminate bias associated with group assignment 
while creating similar sized groups. 
 
Figure 2. Randomisation procedure 
 
 
 
 
 
 
 
 
 
 
 
6 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
6.1 
Assessment and management of risk 
 
The risks involved in this study are minimal. On rare occasions ONS can cause bloating and some 
stomach discomfort. The benefits of using ONS far outweigh risks of consumption, including improving 
the intake of vital energy and protein to help manage malnutrition. Any nutritional products used in the 
study have passed food safety standards and manufacturers (e.g., Huegli) have insurance liability.  
 
N = 50 participants 
Readymade 
Drink (Control) 
Porridge 
(Treatment) 
Readymade 
Drink (Control) 
Porridge 
(Treatment) 
2 Days 
2 Days 
N = 25 
N = 25 

 
 
 
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Products used in the study have been reviewed, verifying the suitability of the ONS content by a 
dietitian specialising in the care of older people (Miss Picton), and are consistent with ESPEN 
guidelines on ONS supplementation for hospitalised older adults. The research team will follow strict 
eligibility criteria, including use of screening tools (e.g., MUST) and will liaise closely with the 
participant’s clinical care team before consent is sought from eligible participants. Participants will 
remain under the supervision of their clinical care team, following standardised nutritional care and 
monitoring of any adverse effects from ONS.  
 
There is perceived to be a low burden to participants volunteering for the study, as the ONS 
supplementation period is low (4 days), and palatability questionnaires will take approximately 10 
minutes to complete with assistance from the research team. The study has been designed to 
optimize benefit and minimize burden to participants. Initially more outcome measures were included, 
such as anthropometric assessment and an increased number of questionnaires, including 
assessment of activities of daily living. After careful consideration and review from co-applicants some 
secondary outcome measures were removed to reduce participant burden while keeping important 
measures in close alignment with the study aims.  
 
Participants that volunteer for interview may find some of the content sensitive, such as exploration of 
their eating habits and the factors that influence dietary consumption. Participants will be made aware 
that the interview can be stopped at any time and that they can skip any of the questions. They will be 
made aware that refusing to answer questions or stopping the interview will in no way impact or 
change their patient care. If participants become upset during the interview they will be asked if they 
would like to continue, or the interview will be stopped. If a participant has a negative emotional 
reaction from an interview, they will be followed up by the research team and asked for permission to 
alert their clinical care team.    
 
Any adverse events will be reported to the CI and PI and recorded in the study site file. The CI or PI 
will report adverse events to the research sponsor. The definition of an adverse event is: “Any 
untoward medical occurrence in a patient which does not necessarily have a causal relationship with 
this study product (i.e., the nutritional supplement)”. This includes “any unfavourable and unintended 
sign (including an abnormal laboratory finding), symptom or disease temporally associated with the 
study intervention (i.e., the nutritional supplement)”. This may include, for example, a cold, or an 
accident. 
 
The definition of a serious adverse event is one that fulfils at least one of the 
following criteria: 
• 
Is fatal – results in death (NOTE: death is an outcome, not an event) 
• 
Is life-threatening 
• 
Requires inpatient hospitalisation or prolongation of existing hospitalisation  
• 
Results in persistent or significant disability/incapacity 
• 
Is a congenital anomaly/birth defect 
 
All serious adverse events should be reported to the study team (CI, or PI) and then onto the study 
sponsor within 24 hours of the investigator becoming aware of the event. 
 
All study staff and clinicians in contact with patients are responsible for noting adverse events that are 
reported by the patient and making them known to appropriate medical staff. Patients entered into the 

 
 
 
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study must be encouraged from the outset of any study to contact their research nurse/team at the 
time of an event occurring. 
 
At each visit, or study assessment, adverse events that might have occurred since the previous visit or 
assessment should be elicited from the patient. For source documentation verification these events 
need to be detailed in the patients’ medical notes including the start dates (if known) of the onset of 
the event as well as the date the event stopped or changed, if applicable. Adverse events ongoing on 
completion of the study should be followed up as required by the protocol and as clinically indicated. 
The clock starts from the time the study team were made aware of the event. The ICH GCP 
Guidelines state that: “All serious adverse events should be reported immediately to the sponsor” (trial 
organisers), and that “immediate reports should be followed promptly by detailed written reports”. 
 
Adverse events will be recorded on the Case Record Form (CRF), including a clear documentation of 
the event, the event start and stop time, the severity of the event, the action taken, and the event 
outcome. All copies of correspondence relating to any adverse event (e.g., emails and telephone 
conversations) will be retained in the main study site file.  
 
6.2  
 Research Ethics Committee (REC) and other Regulatory review & reports 
This study will require ethical approval from the Health Research Authority (HRA). We will submit this 
study for review to the HRA NHS Research Ethics Committee through the Integrated Research 
Application System.  
• 
Substantial amendments that require review by NHS REC will not be implemented until 
that review is in place and other mechanisms are in place to implement at site.   
• 
All correspondence with the REC will be retained. 
• 
It is the Chief Investigator’s responsibility to produce the annual reports as required. 
• 
The Chief Investigator will notify the REC of the end of the study. 
• 
An annual progress report (APR) will be submitted to the REC within 30 days of the 
anniversary date on which the favourable opinion was given, and annually until the 
study is declared ended. 
• 
If the study is ended prematurely, the Chief Investigator will notify the REC, including 
the reasons for the premature termination. 
• 
Within one year after the end of the study, the Chief Investigator will submit a final 
report with the results, including any publications/abstracts, to the REC. 
Discontinuation/Withdrawal of Participants from Study: 
 
Each participant has the right to withdraw from the study at any time and request that any data collected 
be deleted. It will not be possible for the participant to withdraw their data once the analysis has started 
because the data collected will already be pseudonymised and have been used.  
 
Participants can withdraw from the study without giving a reason by contacting the research team. 
 
Withdrawal criteria: 
• 
On the request of the research participant 

 
 
 
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• 
On the advice of the participant’s clinical care team, such as in the event that the oral nutritional 
supplement becomes unsuitable for them  
 
Regulatory Review & Compliance  
Before any site can enrol participants into the study, the Chief Investigator/Principal Investigator will 
ensure that appropriate approvals from participating organisations are in place. Specific arrangements 
on how to gain approval from participating organisations are in place and comply with the relevant 
guidance.  
 
For any amendment to the study, the Chief Investigator/Principal Investigator, in agreement with the 
sponsor will submit information to the appropriate body in order for them to issue approval for the 
amendment. The Chief Investigator/Principle Investigator will work with sites (R&D departments at 
NHS sites as well as the study delivery team) so they can put the necessary arrangements in place to 
implement the amendment to confirm their support for the study as amended. 
 
Amendments  
If the sponsor wishes to make a substantial amendment to the REC application or the supporting 
documents, the sponsor must submit a valid notice of amendment to the REC for consideration. The REC 
will provide a response regarding the amendment within 35 days of receipt of the notice. It is the 
sponsor’s responsibility to decide whether an amendment is substantial or non-substantial for the 
purposes of submission to the REC. 
 
Amendments also need to be notified to the national coordinating function of the UK country where the 
lead NHS R&D office is based and communicated to the participating organisations (R&D office and local 
research team) departments of participating sites to assess whether the amendment affects the NHS 
permission for that site. Note that some amendments that may be considered to be non-substantial for 
the purposes of REC still need to be notified to NHS R&D (e.g. a change to the funding arrangements).  
 
The amendment history will be tracked through allocating version numbers and dates to the protocol and 
any study resources, which will be kept on electronic file by the CI and study sponsors.  
 
6.3  
Peer review 
 
6.4  
Patient & Public Involvement 
 
9 patients (5 male) aged 71-99 years on geriatric wards at UHS completed a pilot palatability survey to 
explore Adams Vital Nutrition Build & Restore fortified oats. The majority of patients chose chocolate 
porridge over golden syrup (8/9). Palatability was measured on a 10-point Likert scale (e.g., 0, not tasty 
at all to 10, very tasty). Patients had a mean taste rating of 7.22, consistency of 7.14 and appearance 
of 7.33. Three patients ate the whole portion, 3 ate half, and 3 ate less than half of the portion. Patients 
were also asked at what time of day they would prefer to eat the product. Four patients preferred to eat 
the product for breakfast, 1 as a mid-afternoon snack, 2 preferred the product in the evening, and 2 
patients would eat the product at any time of day. This pilot helped to inform patient facing materials, 
data collection templates, and gave early indication regarding the palatability of the trial product. 
 

 
 
 
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To help with further development of ONS flavours, a PPI survey was distributed to 25 older adults (age 
86.23 ± 5.93 years; 56% female; 92% White British, 8% Indian) on UHS geriatric medical wards. We 
assessed patients’ likability for porridge and porridge flavours using a 7-point Likert scale from ‘definitely 
like’ (7) to ‘definitely dislike’ (1). Analyses showed a median likability rating of 5 ‘mildly like’ (IQR 3-6) for 
porridge with 60% circling a score in the ‘like’ section of the scale, 8% neither like nor dislike, and 32% 
circling scores in the ‘dislike’ section. Three participants explained they have difficulty swallowing, so 
even though porridge was not their favourite snack they would eat it as they can only manage soft foods. 
When asked ‘what is your favourite type of snack to eat between meals?’ most preferred fruit (n = 7, 
28%), or biscuits (n = 6, 24%), and 16% preferred not to eat any snacks.  
 
The top three flavours of porridge that participants were most likely to eat were golden syrup (44% like, 
8% neither like nor dislike, 48% dislike), strawberries and cream (32% like, 8% neither like nor dislike, 
60% dislike), and apple and cinnamon (32% like, 8% neither like nor dislike, 60% dislike). Participants 
were asked ‘when you make porridge for yourself what flavour do you prefer to eat?’ Participants 
preferred neutral porridge with sugar, strawberry jam, or golden syrup added (n = 18, 72%).  
 
One public and patient representative (PPIR) provided input into this study proposal. They reviewed 
the plain English summary and study proposal and proposed minor changes. Their input will also be 
sought in the development of the study protocol. They will review all patient-facing materials to ensure 
that adequate information is provided to patients and that any written information is understandable 
and jargon-free. PPIR will also be invited to join the study management group. This group will aim to 
meet up quarterly to discuss the study progress and PPIR will be involved throughout the study 
process from development to dissemination of study findings.  
 
In this study, the role of PPI includes: 
 
• 
Reviewing patient-facing materials such as patient information sheet, consent form forms and 
questionnaires. 
• 
Participating in the study steering group to support the delivery of the study. 
• 
Providing input at every stage of the study to ensure that the focus of the study is primarily on 
delivering patient benefit. 
• 
Ensuring that the processes of the study such as data collection, and interviews, are not too 
burdensome for patients. 
• 
Recommending methods or avenues of disseminating research findings to provide a wider 
reach and ensure that patient and the public are informed of the research findings.  
 
 
6.5 Protocol compliance  
 
The Investigator agrees to comply with the requirements of the Protocol and Good Clinical Practice. 
Prospective, planned deviations or waivers to the protocol are not allowed under the UK regulations on 
Clinical Trials and must not be used e.g. it is not acceptable to enrol a subject if they do not meet the 
eligibility criteria or restrictions specified in the trial protocol. 
Accidental protocol deviations can happen at any time. They must be adequately documented on the 
relevant forms and reported to the Chief Investigator and Sponsor immediately.  

 
 
 
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Deviations from the protocol, which are found to frequently recur, are not acceptable and will require 
immediate action by the sponsor. Frequent non-compliances could potentially be classified as a serious 
breach. 
 
 
6.6 
Data protection and patient confidentiality  
The study staff will ensure that the participants’ anonymity is maintained. Data will be identified only by 
a participant ID number. All documents will be stored securely and only accessible by study staff and 
authorised personnel. The study will comply with GDPR and the Data Protection Act 2018, which 
requires data to be anonymised as soon as it is practical to do so. 
 
Participation and all the information collected about participants during the course of the 
research will be kept strictly confidential. Only members of the research team and responsible 
members of the University of Southampton may be given access to participant data for monitoring 
purposes and/or to carry out an audit of the study to ensure that the research is complying with 
applicable regulations. Individuals from regulatory authorities (people who check that we are carrying 
out the study correctly) may require access to participant data. All of these people have a duty to keep 
participant information strictly confidential. 
 
Data collected will be entered electronically on to a computer and stored on the university’s networked 
storage. Access to this information will be password-protected. Hard copies of participant information 
will be stored in a locked filing cabinet in a secure office in our research unit and will be accessible 
only by the research team. Audio recordings for the interviews will be deleted once they have been 
transcribed. Codes are allocated to each participant to ensure that the data is anonymised. Only the 
researchers in this study will have access to the data.  
 
In accordance with regulations we are required to keep participant data secure for 10 years. The data 
may be used in future studies by our research team. If this happens, participant data will be used 
anonymously (non-identifiable participant information) so participants cannot be identified. Any new 
research studies using participant data will be authorised by the local research ethics committee. 
 
All participants will be made aware of the information collected during the research study during 
processes of informed consent through participant information sheets, discussions with the research 
team and completion of consent forms. 
 
ARCHIVING 
 
Archiving will be authorised by the Sponsor following submission of the end of study report.  
Location and duration of record retention for: 
 
• 
Essential documents: Patient case notes will be stored and maintained according to 
standard rules and procedures. Pathology results are stored and maintained according to 
standard procedures. 
• 
Study data will be held for minimum of 5 years 
 
Destruction of essential documents will require authorisation from the Sponsor.   

 
 
 
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 Monitoring, Audits and Inspections 
This study will be monitored and may be participant to monitoring and audit by University Hospital 
Southampton NHS Foundation Trust, under their remit as sponsor and other regulatory bodies to 
ensure adherence to ICH GCP, UK Policy Framework for Health and Social Care Research, 
applicable contracts/agreements and national regulations. All study related documents will be made 
available on request for monitoring and audit by UHS, the relevant REC or other licensing bodies. 
 
6.7 
Indemnity 
The sponsor of the trial is University Hospital Southampton NHS Foundation Trust. For NHS 
sponsored research HSG (96) 48 reference no.2 refers. If there is negligent harm during the clinical 
trial when the NHS body owes a duty of care to the person harmed, NHS Indemnity covers NHS staff, 
medical academic staff with honorary contracts, and those conducting the trial. NHS Indemnity does 
not offer no-fault compensation and is unable to agree in advance to pay compensation for non-
negligent harm. Ex-gratia payments may be considered in the case of a claim. 
 
6.8 
Access to the final study dataset 
Access to data will be granted to relevant members of the research team and authorised 
representatives from the Sponsor for monitoring and/or audit purposes. The data may be used in 
future studies by our research team. If this happens, participant data will be used anonymously (non-
identifiable participant information) so participants cannot be identified. Any new research studies 
using participant data will be authorised by the local research ethics committee. 
 
7 
DISSEMINIATION POLICY 
7.1  
Dissemination policy 
The data arising from the study will be the intellectual property of the University of Southampton. On 
completion of the study, data will be analysed, and a final study report will be prepared. The study report 
can be accessed via clinicaltrials.gov. Research findings will be made available to research participants 
upon request.  
 
The study findings will be presented at national and international scientific meetings. They will also be 
published in peer-reviewed journals to disseminate findings to the scientific community. Social media 
platforms such as Twitter, Facebook and blogs will also be used to disseminate research findings, which 
will achieve a wider reach of scientific and lay communities. Members of PPI in the steering group will 
also provide input on other dissemination methods and ideas.  
 
This ONS acceptability study will provide a basis for future clinical trials working with Adams Vital Nutrition 
Ltd. and could help in the development of future ONS products.  
 
7.2  
Authorship eligibility guidelines and any intended use of professional writers 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and 
any other publications arising from the study. Authorship will be determined per the ICMJE guidelines 
and other contributors will be acknowledged. 

 
 
 
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8 
REFERENCES 
1. 
1. 
Volkert, D., et al., ESPEN guideline on clinical nutrition and hydration in geriatrics. Clin Nutr, 
2019. 38(1): p. 10-47. 
2. 
Cereda, E., et al., Nutritional status in older persons according to healthcare setting: A systematic 
review and meta-analysis of prevalence data using MNA((R)). Clin Nutr, 2016. 35(6): p. 1282-1290. 
3. 
Elia, M., et al., A systematic review of the cost and cost effectiveness of using standard oral nutritional 
supplements in community and care home settings. Clin Nutr, 2016. 35(1): p. 125-137. 
4. 
Sobotka, L., Basics in Clinical Nutrition. 2012: Galen. 
5. 
Elia, M. and R.J. Stratton, Calculating the cost of disease related malnutrition in the UK in 2007 (public 
expenditure only). in Combating Malnutrition: Recommendations for Action A Report from the Advisory 
Group on Malnutrition Led by BAPEN, M. Elia and C.A. Russel, Editors. 2009, Redditch: BAPEN. p. 39-46. 
6. 
Norman, K., et al., Prognostic impact of disease-related malnutrition. Clin Nutr, 2008. 27(1): p. 5-15. 
7. 
Rus, G.E., et al., Nutrition interventions implemented in hospital to lower risk of sarcopenia in older 
adults: A systematic review of randomised controlled trials. Nutr Diet, 2020. 77(1): p. 90-102. 
8. 
Roberts, H.C., et al., The Challenge of Managing Undernutrition in Older People with Frailty. Nutrients, 
2019. 11(4). 
9. 
Pullen, K., et al., Are energy and protein requirements met in hospital? J Hum Nutr Diet, 2018. 31(2): p. 
178-187. 
10. 
Roberts, H.C., et al., The feasibility and acceptability of training volunteer mealtime assistants to help 
older acute hospital inpatients: the Southampton Mealtime Assistance Study. J Clin Nurs, 2014. 23(21-
22): p. 3240-9. 
11. 
Volkert, D., et al., Management of Malnutrition in Older Patients-Current Approaches, Evidence and 
Open Questions. J Clin Med, 2019. 8(7). 
12. 
Cox, N.J., et al., New horizons in appetite and the anorexia of ageing. Age Ageing, 2020. 49(4): p. 526-
534. 
13. 
Cawood, A.L., M. Elia, and R.J. Stratton, Systematic review and meta-analysis of the effects of high 
protein oral nutritional supplements. Ageing Res Rev, 2012. 11(2): p. 278-96. 
14. 
Milne, A.C., et al., Protein and energy supplementation in elderly people at risk from malnutrition. 
Cochrane Database Syst Rev, 2009(2): p. CD003288. 
15. 
Stratton, R.J., X. Hebuterne, and M. Elia, A systematic review and meta-analysis of the impact of oral 
nutritional supplements on hospital readmissions. Ageing Res Rev, 2013. 12(4): p. 884-97. 
16. 
Mullin, G.E., et al., The Association between Oral Nutritional Supplements and 30-Day Hospital 
Readmissions of Malnourished Patients at a US Academic Medical Center. J Acad Nutr Diet, 2019. 
119(7): p. 1168-1175. 
17. 
Zhong, Y., et al., The Cost-Effectiveness of Oral Nutrition Supplementation for Malnourished Older 
Hospital Patients. Appl Health Econ Health Policy, 2017. 15(1): p. 75-83. 
18. 
Baldwin, C., et al., Quality of the Evidence Supporting the Role of Oral Nutritional Supplements in the 
Management of Malnutrition: An Overview of Systematic Reviews and Meta-Analyses. Adv Nutr, 2021. 
12(2): p. 503-522. 
19. 
Darmon, P., et al., Oral nutritional supplements and taste preferences: 545 days of clinical testing in 
malnourished in-patients. Clin Nutr, 2008. 27(4): p. 660-5. 
20. 
Gosney, M., Are we wasting our money on food supplements in elder care wards? J Adv Nurs, 2003. 
43(3): p. 275-80. 

 
 
 
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21. 
Hashizume, N., et al., Adherences to oral nutritional supplementation among hospital outpatients: An 
online cross-sectional survey in Japan. PLoS One, 2019. 14(9): p. e0222972. 
22. 
Hubbard, G.P., et al., A systematic review of compliance to oral nutritional supplements. Clin Nutr, 
2012. 31(3): p. 293-312. 
23. 
Jobse, I., et al., Compliance of nursing home residents with a nutrient- and energy-dense oral nutritional 
supplement determines effects on nutritional status. J Nutr Health Aging, 2015. 19(3): p. 356-64. 
24. 
Hébuterne, X., et al., Effectiveness and tolerance of an oral nutritional supplement highly concentrated 
in protein and energy in elderly subjects at risk of malnutrition. Nutrition clinique et métabolisme 2020. 
34: p. 156-160. 
25. 
Yeomans, M.R., Taste, palatability and the control of appetite. Proc Nutr Soc, 1998. 57(4): p. 609-15. 
26. 
Nieuwenhuizen, W.F., et al., Older adults and patients in need of nutritional support: review of current 
treatment options and factors influencing nutritional intake. Clin Nutr, 2010. 29(2): p. 160-9. 
27. 
den Boer, A., S. Boesveldt, and J.B. Lawlor, How sweetness intensity and thickness of an oral nutritional 
supplement affects intake and satiety. Food Quality and Preference, 2019. 71: p. 406-414. 
28. 
Thomas, A., et al., Alternating temporal dominance of sensations and liking scales during the intake of a 
full portion of an oral nutritional supplement. Food Quality and Preference, 2016. 53: p. 159-167. 
29. 
Thomas, A., et al., Temporal drivers of liking for oral nutritional supplements for older adults 
throughout the day with monitoring of hunger and thirst status. Food Quality and Preference, 2018. 70: 
p. 40-48. 
30. 
Regan, E., et al., 2021. Food Quality and Preference, Exploring how age, medication usage, and 
dentures effect the sensory perception and liking of oral nutritional supplements in older adults. 92. 
31. 
Mills, S.R., et al., Can fortified foods and snacks increase the energy and protein intake of hospitalised 
older patients? A systematic review. J Hum Nutr Diet, 2018. 31(3): p. 379-389. 
32. 
Taib, A., et al., Can an Ice-Cream Based Supplement Help Address Malnutrition in Orthogeriatric 
Patients? J Nutr Gerontol Geriatr, 2021. 40(4): p. 280-289. 
33. 
Correa-Arruda, W.S., et al., Effects of overnight fasting on handgrip strength in inpatients. Einstein (Sao 
Paulo), 2019. 17(1): p. eAO4418. 
34. 
Ansar, W. and S. Ghosh, C-reactive protein and the biology of disease. Immunol Res, 2013. 56(1): p. 
131-42. 
35. 
Treacy, M., et al., Understanding the use of the National Early Warning Score 2 in acute care settings: a 
realist review protocol. BMJ Open, 2022. 12(7): p. e062154. 
36. 
Volkert, D., et al., Development of a Model on Determinants of Malnutrition in Aged Persons: A 
MaNuEL Project. Gerontol Geriatr Med, 2019. 5: p. 2333721419858438. 
37. 
Pilgrim, A.L., et al., Measuring Appetite with the Simplified Nutritional Appetite Questionnaire Identifies 
Hospitalised Older People at Risk of Worse Health Outcomes. J Nutr Health Aging, 2016. 20(1): p. 3-7. 
38. 
Lau, S., et al., The Simplified Nutritional Appetite Questionnaire (SNAQ) as a Screening Tool for Risk of 
Malnutrition: Optimal Cutoff, Factor Structure, and Validation in Healthy Community-Dwelling Older 
Adults. Nutrients, 2020. 12(9). 
39. 
Wilson, M.M., et al., Appetite assessment: simple appetite questionnaire predicts weight loss in 
community-dwelling adults and nursing home residents. Am J Clin Nutr, 2005. 82(5): p. 1074-81. 
40. 
Ida, S., R. Kaneko, and K. Murata, SARC-F for Screening of Sarcopenia Among Older Adults: A Meta-
analysis of Screening Test Accuracy. J Am Med Dir Assoc, 2018. 19(8): p. 685-689. 
41. 
Raiche, M., R. Hebert, and M.F. Dubois, PRISMA-7: a case-finding tool to identify older adults with 
moderate to severe disabilities. Arch Gerontol Geriatr, 2008. 47(1): p. 9-18. 
42. 
Hoogendijk, E.O., et al., The identification of frail older adults in primary care: comparing the accuracy 
of five simple instruments. Age Ageing, 2013. 42(2): p. 262-5. 
43. 
I, I.J., et al., The palatability of oral nutritional supplements: before, during, and after chemotherapy. 
Support Care Cancer, 2016. 24(10): p. 4301-8. 

 
 
 
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44. 
McGough, C., et al., Taste preferences for oral nutrition supplements in patients before and after pelvic 
radiotherapy: a double-blind controlled study. Clin Nutr, 2006. 25(6): p. 906-12. 
45. 
Fiatarone Singh, M.A., et al., The effect of oral nutritional supplements on habitual dietary quality and 
quantity in frail elders. J Nutr Health Aging, 2000. 4(1): p. 5-12. 
46. 
Gariballa, S.E. and S.J. Forster, Dietary intake of older patients in hospital and at home: the validity of 
patient kept food diaries. J Nutr Health Aging, 2008. 12(2): p. 102-6. 
47. 
Ui Dhuibhir, P., N. Collura, and D. Walsh, Complete Oral Nutritional Supplements: Dietitian Preferences 
and Clinical Practice. J Diet Suppl, 2019. 16(1): p. 40-50. 
48. 
Braun, V. and V. Clarke, Thematic analysis: Practical guide. 2022, London: Sage. 
49. 
Elia, M., THE ‘MUST’ REPORT Nutritional screening of adults: a multidisciplinary responsibility. 
Development and use of the ‘Malnutrition Universal Screening Tool’ (‘MUST’) for adults. 2003, The 
British Association for Parenteral and Enteral Nutrition. 
50. 
Elia, M. and R.J. Stratton, Considerations for screening tool selection and role of predictive and 
concurrent validity. Curr Opin Clin Nutr Metab Care, 2011. 14(5): p. 425-33. 
51. 
Stratton, R.J., et al., Malnutrition in hospital outpatients and inpatients: prevalence, concurrent validity 
and ease of use of the 'malnutrition universal screening tool' ('MUST') for adults. Br J Nutr, 2004. 92(5): 
p. 799-808. 
52. 
Urbaniak, G.C. and S. Plous. Research Randomizer. 2022; Available from: https://www.randomizer.org/. 
 

 
 
 
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9.  
APPENDICIES 
 
9.1 
Appendix 1- Required documentation  
Consultant Letter 
Referee’s Report 
Data Collection Booklet 
Interview Schedule 
ONS Product Specification  
 
9.2  
Appendix 2 – Schedule of Procedures  
 
Procedures 
No. received 
per 
participant 
Time 
Who  
Location 
Written consent (patients & staff) 
1 
5-10 
mins 
SL & SM 
Hospital wards 
Baseline questionnaire data 
collection (patients) 
1 
15-20 
mins 
SM 
Hospital wards  
 
Completion of daily food diary/chart  
6 
15-20 
mins 
Nurses 
Hospital wards 
Measurement of ONS intake 
8 
variable 
SM 
Hospital wards 
Assessment of ONS palatability 
(patients) 
2 
10-15 
mins 
SM  
Hospital wards 
Interview (patients & staff) 
1 
25-45 
mins 
SM 
UHS office, hospital ward, 
telephone, or online 
depending on participant 
preference 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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9.3 Appendix 3 - Gantt Chart 
 
2022 
2023 
 
O/N 
D 
J/F 
M/A 
M/J 
J/A 
S/O 
N/D 
Ethical 
Approval 
 
 
 
 
 
 
 
 
Participant 
Recruitment 
 
 
 
 
 
 
 
 
ONS Testing 
(data 
collection) 
 
 
 
 
 
 
 
 
Qualitative 
Interview 
 
 
 
 
 
 
 
 
Data Analysis  
 
 
 
 
 
 
 
Report 
& 
Dissemination 
of Findings 
 
 
 
 
 
 
 
 
 
9.4 
Appendix 4 – Amendment History 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
1 
1.1 
31/05/2024 
S J Meredith 
Eligibility criteria have changed: 
‘Receiving ONS in previous month’ has 
been taken out of the exclusion criteria. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Clinical Care Team Notification Letter 
 
UHS ONS Compliance & Palatability Study: Compliance and palatability of fortified 
porridge compared to standard liquid-based ONS in hospitalised older adults with 
malnutrition 
 
Dear UHS Clinical Care Team                                                                Date: XXX 
 
Your patient, XXX, has agreed to take part in the above study. This is a mixed methods 
randomised controlled crossover design co-ordinated by the study management team at the 
University of Southampton and the research sponsor at University Hospital Southampton 
NHS Foundation Trust.  
 
This study aims to investigate the compliance and palatability of fortified porridge 
(treatment) in malnourished hospitalised older adults compared to a liquid-based ONS 
(control). The acceptability of products will also be assessed through qualitative interviews.  
 
This study will involve your patient consuming two different types of ONS twice per day for 4 
days, in addition to normal meals, in a crossover design. The products will be offered in-
between breakfast and lunch, and after dinner. We will assess your patient’s compliance to 
ONS through measuring ONS leftovers, and we will assess palatability of ONS products using 
Likert scales. We will also assess your patient’s frailty status (PRISMA-7), risk of sarcopenia 
(SARC-F) and appetite (SNAQ) at baseline. They may also be asked for an interview to 
explore their experiences of using the ONS products.  
 
Your patient has been provided with verbal and written information for the study (copy 
enclosed) which explains why s/he has been approached to take part in the research, that the 
participation is entirely voluntary, and emphasises that they are free to withdraw from the 
study at any time without prejudicing their future medical care.  
 
Should you have any questions or require further information about this research, please do 
not hesitate to contact the chief investigator in charge of the local study.  
 
Dr Stephen Lim, Consultant Geriatrician, Academic Geriatric Medicine, University Hospital 
Southampton NHS FT, Tremona Road, Southampton, SO16 6YD Telephone: 02381206131. 
Email: s.e.lim@soton.ac.uk 
 
Yours sincerely,  
 
Dr Samantha Jane Meredith 
 
Research Fellow 
University of Southampton 
Academic Geriatric Medicine 
s.j.meredith@soton.ac.uk  

 
 
 
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University Hospital Southampton NHS Foundation Trust  
Scientific Peer Review Form 
 
PROJECT TITLE 
Compliance and palatability of fortified porridge 
compared to standard liquid-based oral nutritional 
supplementation in hospitalised older adults with 
malnutrition 
 
CHIEF INVESTIGATOR 
Dr Stephen Lim 
 
STUDENT (if applicable) 
 
 
 
All studies which are requesting sponsorship from University Hospital Southampton NHS Foundation 
Trust will require two supporting peer reviews to assist in the verification of the scientific quality and 
robustness of the study. 
 
Please note no internal peer review is required for projects where an external body is 
undertaking a review as part of a funding application but should include confirmation of the 
funding award with the Sponsorship request. 
 
SCIENTIFIC QUALITY PEER REVIEW 
ASSESSMENT CRITERIA 
YES 
NO 
UNCLEAR 
N/A 
1. Study Design 
 
 
 
 
Does the research have a clear protocol? 
 
 
 
 
Is the research question or hypothesis clearly stated? 
 
 
 
 
Are the project objectives described? 
 
 
 
 
Are the objectives realistic? 
 
 
 
 
Has other relevant research been reviewed? 
 
 
 
 
Is the methodology appropriate to the research question? 
 
 
 
 
Have the methods of measurement been described? 
 
 
 
 

 
 
 
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Has the reliability and validity of measurement been 
reviewed? 
 
 
 
 
If available, are validated scales of measurement being 
used? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
 
 
2. Study sample and data analysis 
 
 
 
 
Is the proposed population group appropriately 
representative? 
 
 
 
 
Is the sample size justified and realistic? 
 
 
 
 
Are the methods of data analysis (statistical or otherwise) 
described and appropriate? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
 
3. Impact and importance 
 
 
 
 
Are the expected values and benefits of the research clear? 
 
 
 
 
Will the research add to current knowledge or have training 
value? 
 
 
 
 
Is the research generalisable i.e. have potential application 
beyond the Trust? 
 
 
 
 
Will the findings lead to significant health gains and/or benefit 
the Trust/ NHS/ population? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 

 
 
 
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4. Dissemination 
 
 
 
 
Do the researchers intend to disseminate research findings 
in an appropriate journal ? 
 
 
 
 
Will the results of the research be made available to 
research participants? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
 
5. Feasibility 
 
 
 
 
Is the research feasible within the local context? 
 
 
 
 
Is the project feasible within the timeframe and resources 
proposed? 
 
 
 
 
Is the proposed research likely to put the Trust, Trust staff, 
participants in the research or the applicants at risk, which 
are such that these should specifically be taken into account 
when deciding whether or not to support the research? 
 
 
 
 
Where relevant, has a multidisciplinary and multi-
professional approach to addressing the research question 
been adopted? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
Research is unlikely to put trust/staff/patients at specific risk to be taken into account. 
 
 

 
 
 
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6. Consumer Involvement 
 
 
 
 
Where relevant, have patients or their representatives been 
involved in this project? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
 
 
OVERALL RATING 
(Scale of 1-5 were 1 indicates poor, 3 acceptable and 5 excellent) 
5 
 
Overall Comments 
Please provide comments you may wish to make on the proposal, particularly any suggestions as to 
how the project could be amended.  Your comments will be used to provide feedback to the Principal 
Investigator. 
 
 
This study proposal demonstrates potential for direct patient benefit for older hospital 
inpatients with malnutrition, who’s management poses a significant clinical challenge. The 
project appears feasible and deliverable in the proposed timeframe with no concerns within 
the protocol or intervention identified. 
 
Additional data which might be considered for collection would be markers of acute illness 
such as early warning score and c-reactive protein routinely collected in clinical care, which 
will not add to participant burden but may be useful to determine factors affecting palatability 
and compliance and for future trials. 
 
 
 

 
 
 
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REVIEWER 
RECOMMENDATION 
 
 
Approve: 
 
 
 
Approve with amendments described above: 
 
 
 
 
Resubmit after amendments described above:     
 
 
 
 
Reject: 
 
 
 
Signature: 
(please provide a physical 
signature and not a copy of a 
scanned example) 
 
 
Printed Name:  
 
Dr Natalie Cox 
 
Job Title & 
Organisation:  
 
Visiting research fellow academic geriatric medicine and 
specialist registrar geriatric medicine. 
Date: 
 
05/10/2022 
 
University Hospital Southampton NHS Foundation Trust  
Scientific Peer Review Form 
 
PROJECT TITLE 
Compliance and palatability of fortified porridge 
compared to standard liquid-based oral nutritional 

 
 
 
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supplementation in hospitalised older adults with 
malnutrition 
 
CHIEF INVESTIGATOR 
Dr Stephen Lim 
 
STUDENT (if applicable) 
 
 
 
All studies which are requesting sponsorship from University Hospital Southampton NHS Foundation 
Trust will require two supporting peer reviews to assist in the verification of the scientific quality and 
robustness of the study. 
 
Please note no internal peer review is required for projects where an external body is 
undertaking a review as part of a funding application but should include confirmation of the 
funding award with the Sponsorship request. 
 
SCIENTIFIC QUALITY PEER REVIEW 
ASSESSMENT CRITERIA 
YES 
NO 
UNCLEAR 
N/A 
1. Study Design 
 
 
 
 
Does the research have a clear protocol? 
 
 
 
 
Is the research question or hypothesis clearly stated? 
 
 
 
 
Are the project objectives described? 
 
 
 
 
Are the objectives realistic? 
 
 
 
 
Has other relevant research been reviewed? 
 
 
 
 
Is the methodology appropriate to the research question? 
 
 
 
 
Have the methods of measurement been described? 
 
 
 
 
Has the reliability and validity of measurement been 
reviewed? 
 
 
 
 
If available, are validated scales of measurement being 
used? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
- 
It would be helpful to clarify how and who will prepare the ONS products on wards 
(are these the HCPs that will be interviewed too?). How would the leftovers of ONS 

 
 
 
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will be measured (?visually) to ensure that it is standardised ? Are the food diaries 
part of usual care already on the wards?  
- 
 
2. Study sample and data analysis 
 
 
 
 
Is the proposed population group appropriately 
representative? 
 
 
 
 
Is the sample size justified and realistic? 
 
 
 
 
Are the methods of data analysis (statistical or otherwise) 
described and appropriate? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
3. Impact and importance 
 
 
 
 
Are the expected values and benefits of the research clear? 
 
 
 
 
Will the research add to current knowledge or have training 
value? 
 
 
 
 
Is the research generalisable i.e. have potential application 
beyond the Trust? 
 
 
 
 
Will the findings lead to significant health gains and/or benefit 
the Trust/ NHS/ population? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
 
 
4. Dissemination 
 
 
 
 
Do the researchers intend to disseminate research findings 
in an appropriate journal ? 
 
 
 
 
Will the results of the research be made available to 
research participants? 
 
 
 
 

 
 
 
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If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
 
5. Feasibility 
 
 
 
 
Is the research feasible within the local context? 
 
 
 
 
Is the project feasible within the timeframe and resources 
proposed? 
 
 
 
 
Is the proposed research likely to put the Trust, Trust staff, 
participants in the research or the applicants at risk, which 
are such that these should specifically be taken into account 
when deciding whether or not to support the research? 
 
 
 
 
Where relevant, has a multidisciplinary and multi-
professional approach to addressing the research question 
been adopted? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
As above, some clarity on preparation of the ONS whether if this will be by study team or 
HCP to ensure it’s feasible within a busy ward setting  
 
 
 
6. Consumer Involvement 
 
 
 
 
Where relevant, have patients or their representatives been 
involved in this project? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
 

 
 
 
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OVERALL RATING 
(Scale of 1-5 were 1 indicates poor, 3 acceptable and 5 excellent) 
4 
 
Overall Comments 
Please provide comments you may wish to make on the proposal, particularly any suggestions as to 
how the project could be amended.  Your comments will be used to provide feedback to the Principal 
Investigator. 
 
Clear background and aims of the study with key and relevant outcomes measures. Minor 
clarification on the methods for data collection would be helpful as described above.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REVIEWER 
RECOMMENDATION 
 
 
Approve: 
 
 
 
Approve with amendments described above: 
 
 
 
 
Resubmit after amendments described above:     
 
 
 
 
Reject: 
 
 
 
Signature: 
 

 
 
 
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(please provide a physical 
signature and not a copy of a 
scanned example) 
 
Printed Name:  
 
Qian Yue Tan 
 
Job Title & 
Organisation:  
 
Specialist Registrar Geriatric Medicine and Clinical Research 
Fellow Academic Geriatric Medicine, University Hospital 
Southampton NHS FT  
Date: 
01.09.2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Date Information Collected: 
 
 
 
 
 
 
 
d 
d 
m 
m 
y 
y 
Gender:  
Male = 0 
Female = 
1  
 
 
 
 
 
 
 
Date of Birth: 
 
 
 
 
 
 
 
d 
d 
m 
m 
y 
y 
    
 
SOCIAL CIRCUMSTANCES 
 
 
Marital status: 
Single = 1 
Married = 2 
Divorced or separated = 3  
Widowed = 4 
Cohabiting = 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
Usual Residence: 
Private home living alone = 1 
Private home living with friends or relatives = 2 
Sheltered accommodation = 3 
Residential/Rest Home = 4 
Nursing Home = 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Care provision: 
o No care required     = 0 
o Informal provision = 1 
o Formal provision     = 2 
 
 
 
 
Tobacco and alcohol consumption: 
 
 
 
 
 
 
Smoking 
Never = 
1 
Ex = 2 
Current = 3 
 
 
 
 
 
 
 
 
 
Cigarette pack years 
 
 
 
 
 
 
 
 
Alcohol units per week 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Short Nutritional Assessment Questionnaire (SNAQ) 
1. My appetite is: 
a. Very Poor 
b. Poor 
c. Average 
d. Good 
e. Very Good 
 
2. When I eat: 
a. I feel full after eating only a few mouthfuls 
b. I feel full after eating about a third of a meal 
c. I feel full after eating over half a meal 
d. I feel full after eating most of the meal 
e. I hardly ever feel full 
 
3. Food tastes: 
a. Very bad 
b. Bad 
c. Average 
d. Good  
e. Very good 
 
4. Normally I eat: 
a. Less than one meal a day 
b. One meal a day 
c. Two meals a day 
d. Three meals a day 
e. More than three meals a day 
 
 
Total Score: _________/20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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PRISMA-7 Questionnaire 
 
Patient Questions 
Yes 
No 
1. 
Are you older than 85 years? 
 
 
2. 
Are you male? 
 
 
3. 
In general, do you have any health problems that 
require you to limit your activities? 
 
 
4. 
Do you need someone to help you on a regular 
basis? 
 
 
5. 
In general, do you have any health problems that 
require you to stay at home? 
 
 
6. 
If you need help, can you count on someone 
close to you? 
 
 
7. 
Do you regularly use a stick, walker, or 
wheelchair to move about?  
 
 
 
Total checked:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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SARC–F screening tool 
Component 
Question 
Scoring 
Strength 
How much difficulty do you 
have in lifting and carrying 10lb 
(5 bags of sugar)? 
None = 0 
Some = 1 
A lot or unable = 2 
Assistance in 
walking 
How much difficulty do you 
have walking across a room? 
None = 0 
Some = 1 
A lot, use aids,  or unable = 2 
Rise from a 
chair 
How much difficulty do you 
have transferring from a chair 
or bed? 
None = 0 
Some = 1 
A lot or unable without help = 
2 
Climb stairs 
How much difficulty do you 
have climbing a flight of 10 
stairs? 
None = 0 
Some = 1 
A lot or unable = 2 
Falls 
How many times have you 
fallen in the past year? 
None = 0 
1 – 3 falls = 1 
≥ 4 falls = 2 
Total score  
 
 
 
 
 
 
 

 
 
 
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ONS INTAKE 
 
Date: __________________  Ward: __________________ 
 
ONS Product (please circle & write flavour):    
 
Build & Restore Porridge (____________) / Fortisip (___________) 
 
MORNING ONS 
 
Amount given (g): _______________                      Amount left (g): _________________ 
 
Total Intake (g): _________________ 
 
Total Energy Intake (kcal): ____________              Total Protein Intake (g): _____________ 
 
 
EVENING ONS 
 
Amount given (g): _______________                      Amount left (g): _________________ 
 
Total Intake (g): _________________ 
 
Total Energy Intake (kcal): ____________              Total Protein Intake (g): _____________ 
 
 
 
TOTAL ONS INTAKE 
 
Amount given (g): _______________                      Amount left (g): _________________ 
 
Total Intake (g): _________________ 
 
Total Energy Intake (kcal): ____________              Total Protein Intake (g): _____________ 
 
 
 
 
 
 
 
 
 

 
 
 
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PALATABILITY 
 
Date: ___________________  Ward: ________________ 
 
ONS Product (please circle & write flavour):    
 
Build & Restore Porridge (____________) / Fortisip Compact (___________) 
 
Look at the product. Note: Do not taste yet! Please, answer the following question (circle): 
Based on the sample appearance how much do you expect to like the taste of this product? 
 
 
 
Definitely 
Like 
Moderately 
Like 
Mildly Like 
Neither 
Like nor 
Dislike  
Mildly 
Dislike 
Moderately 
Dislike 
Definitely 
Dislike 
 
Smell the product. Note: Do not taste yet! Please, answer the following question (circle): 
Based on the sample smell, how much do you expect to like the taste of this product? 
 
 
 
Definitely 
Like 
Moderately 
Like 
Mildly Like 
Neither 
Like nor 
Dislike  
Mildly 
Dislike 
Moderately 
Dislike 
Definitely 
Dislike 
 
Please, take a bite/mouthful and answer the following question: 
How much do you like the taste of this product? 
 
 
 
Definitely 
Like 
Moderately 
Like 
Mildly Like 
Neither 
Like nor 
Dislike  
Mildly 
Dislike 
Moderately 
Dislike 
Definitely 
Dislike 
 
 
 
 
 
 
 
 

 
 
 
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Please take another bite/mouthful and answer the following questions: 
How much do you like the sweetness of this product? 
 
 
 
Definitely 
Like 
Moderately 
Like 
Mildly Like 
Neither 
Like nor 
Dislike  
Mildly 
Dislike 
Moderately 
Dislike 
Definitely 
Dislike 
 
How much do you like the texture/mouth feel of this product? 
 
 
 
Definitely 
Like 
Moderately 
Like 
Mildly Like 
Neither 
Like nor 
Dislike  
Mildly 
Dislike 
Moderately 
Dislike 
Definitely 
Dislike 
 
How much do you like the thickness of this product? 
 
 
 
Definitely 
Like 
Moderately 
Like 
Mildly Like 
Neither 
Like nor 
Dislike  
Mildly 
Dislike 
Moderately 
Dislike 
Definitely 
Dislike 
 
 
Please answer the following questions after swallowing the product. 
After swallowing, how much do you like the aftertaste of this product? 
 
 
 
Definitely 
Like 
Moderately 
Like 
Mildly Like 
Neither 
Like nor 
Dislike  
Mildly 
Dislike 
Moderately 
Dislike 
Definitely 
Dislike 
 
 
 
 
 
 
 
 

 
 
 
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After swallowing, how much do you like the feeling in your mouth associated with the product? 
 
 
 
Definitely 
Like 
Moderately 
Like 
Mildly Like 
Neither 
Like nor 
Dislike  
Mildly 
Dislike 
Moderately 
Dislike 
Definitely 
Dislike 
 
Indicate to what extent you agree with this statement: 
 
“I like this product and would be happy to choose this product in future”  
 
 
 
I strongly 
agree 
I largely 
agree 
I agree 
somewhat 
I neither 
agree nor 
disagree 
I disagree 
somewhat 
I largely 
disagree 
I strongly 
disagree 
 
Comments: 
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________ 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Interview Schedule – Patients 
 
A) Explore general eating behaviours and food intake 
1. In general, what do you normally eat during the day? 
2. Is there anything that puts you off from eating, or that you struggle with when eating, or 
getting food? 
• Explore appetite 
• Explore food preparation and cost 
• Explore physical abilities (e.g., teeth, pain) 
3. What kind of things encourage you to eat regularly, or makes eating easier? 
• Explore support from others 
• Taste preferences 
• Food preparation 
B) Explore experiences of eating in hospital 
4. What are your views and experiences of the food you have eaten in the hospital?  
5. Did you need any help/support when eating your food? 
C) Explore experiences using ONS in hospital  
6. What did you think about the drinks (liquid-based ONS) you were given in-between 
your meals?  
• What were the good things about the drink? 
• Were there any bad things about the drink, or anything to improve? 
• What did they taste like?  
• Did you manage to drink both drinks over the day? Explore supplement 
fatigue/boredom 
7. What did you think about the porridge (fortified ONS) you were given between your 
meals?  
• What were the good things about the porridge? 
• Were there any bad things about the porridge, or anything to improve? 
• What did the porridge taste like? (explore palatability when hot and cold) 
• Did you manage to eat both porridge supplements over the day? Explore 
supplement fatigue/boredom 

 
 
 
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8. What are your favourite snacks? Is there anything that you would prefer to eat in-
between your meals in the hospital? 
D) Explore perceived eating/food improvements required in hospital 
9. What could improve your experience of eating food in the hospital? 
10. What kind of food would you like to eat in hospital?  
E) Explore nutrition/diet transition from hospital to community 
11.  When you leave hospital how confident are you that you can eat a healthy diet? 
Explore answer e.g., what makes you this confident? 
12. Would you consider eating anything like the porridge or drinks in-between meals when 
you are at home? Why is this? 
F) Explore any other comments 
13. Do you have anything else to say about your diet/eating? 
14. Do you have anything else to say about the porridge or drinks that you were given in-
between your meals in hospital?   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Interview Schedule – Staff 
 
A) Explore staff role in malnutrition management 
1. Could you explain what your job role is at the hospital? 
2. Within your job role could you explain/describe the input you have regarding an older 
patient’s nutrition and eating? 
3. If you come across a patient with malnutrition what is the process for treatment? In 
what ways does the hospital optimise nutrition for older patients with malnutrition?  
B) Explore general use of ONS in hospital 
4. In general, what is the prescription and management of ONS like in hospital for older 
malnourished patients? 
5. What are your views about the use of ONS for older patients with malnutrition? 
6. What are the benefits of using ONS? 
7. What are your concerns with using ONS? 
8. What are the barriers to using ONS in hospital with patients? In your view, what are the 
things that patients struggle with when using ONS? 
9. How can these things be addressed? What factors facilitate the use of ONS in hospital 
with older patients? 
C) Explore specific ONS products used in the trial 
10. What do you think about the use of liquid-based ONS for malnourished patients in 
hospital?  
• Benefits of the ONS? 
• Disadvantages of the ONS, or anything to improve? 
11. What do you think about the fortified porridge for malnourished older patients? 
• Benefits of the porridge? Good things about the porridge? 
• Disadvantages, or barriers when using the porridge? 
• Would you use the porridge regularly with your patients? Why? 
12. In your view, what are the best types of ONS to use in hospital? Why? 
13. What needs to be changed to optimise patients’ nutrition in hospital? 
D) Explore perceptions of future improvements required for malnourished older 
adults nutritional care/support  

 
 
 
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14. Do you feel you have sufficient support and resources to deliver optimal malnutrition 
management for older patients? 
15. Does anything need to be changed to improve nutrition support for malnourished older 
adults in hospital? 
16. Do you have anything else you would like to say about using ONS to manage 
malnutrition in hospital? 
17. Do you have anything else you would like to add about the porridge or liquid-based 
ONS used in this study?  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Anonymous liquid-based ONS product specification 
 
 
 

 
 
 
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Adams Vital Nutrition Ltd. Vital Daily High Protein Oats - product specification 
P r o d u c t   S p e c i f i c a t i o n  
 
VITAL DAILY PORRIDGE GF GOLDEN SYRUP
Valid in:  
United Kingdom 
Manufactured in: 
UK 
General description: 
Golden Syrup flavour porridge fortified with vitamins and minerals 
  
Product information 
suitable for 
vegans contains 
no yeast extract 
high protein 
gluten free 
According to regulation 828/2014/EU 
Characteristics 
 
Texture: 
powder 
 
Texture (after preparation): 
homogeneous 
 
Convenience: 
instant 
 Preparation 
Cooking time: 0 minutes 
Quantity 
Ingredient 
Temperature 
Instruction 
57.00 g 
100.00 g 
product 
water 
- 
- 
57g powder to 100ml boiling water. Mix well 
Yield ca.: 157.000 g 
 
  
Shelf life (provisional) 
12 Months 
Storage instructions 
Keep in a cool and dry place (8-25°C) and protect from light and frost. Always close the container properly. 
Nutrition Information 
Unit 
Typical 
value 
per 
100g 
GDA 
[%]* 
typical 
value per 
100g 
Per serving 
per 100g 
GDA [%]* 
per serving 
per 100g 
Per serving 
per 157g 
GDA [%]* 
per serving 
per 157g 
Energy 
kJ 
1652  
600  
941  
kcal 
391 
20 
142 
7 
223 
11 
fat 
g 
7.8 
11.1 
2.8 
4.0 
4.4 
6.3 
of which: 
 
 
 
 
 
 
- saturates 
g 
1.6 
8.0 
0.6 
2.9 
0.9 
4.6 
carbohydrate 
g 
55.8 
21.5 
20.3 
7.8 
31.8 
12.2 
of which: 
 
 
 
 
 
 
- sugars 
g 
32.7 
36.3 
11.9 
13.2 
18.6 
20.7 
fibre 
g 
4.5  
1.6  
2.6  

 
 
 
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protein 
g 
21.2 
42.4 
7.7 
15.4 
12.1 
24.2 
salt** 
g 
0.75 
12.51 
0.27 
4.54 
0.43 
7.13 
**Salt calculated from the sodium content * 2.5 
* = % of the daily "reference intake of an average adult (8400 kJ / 2000 kcal)". The nutritional needs of individuals may be 
higher or lower, based on gender, age, level of physical activity and other factors. 
  
Additional Nutrition Information 
Unit 
Typical 
value 
per 
100g 
GDA 
[%]* 
typical 
value per 
100g 
Per serving 
per 100g 
GDA [%]* 
per serving 
per 100g 
Per serving 
per 157g 
GDA [%]* 
per serving 
per 157g 
moisture 
g 
8.0  
 
 
 
 
salt (NaCl) 
g 
0.3  
0.1  
0.2  
calories out of protein 
kcal 
85  
31  
48  
sodium 
g 
0.30  
0.11  
0.17  
  
 
Health&Nutrition 
information value 
Unit 
100% RDA 
Typical value 
per 100g 
%* 
Per serving 
per 100g 
%* 
Per serving 
per 157g 
%* 
calcium 
mg 
800.00 
368.98 
46.12 
133.96 
16.74 
210.32 
26.29 
copper 
mg 
1.00 
0.95 
94.87 
0.34 
34.44 
0.54 
54.07 
iodine 
µg 
150.00 
63.00 
42.00 
22.87 
15.25 
35.91 
23.94 
iron 
mg 
14.00 
11.52 
82.30 
4.18 
29.88 
6.57 
46.91 
magnesium 
mg 
375.00 
133.33 
35.55 
48.41 
12.91 
76.00 
20.27 
phosphorus 
mg 
700.00 
363.71 
51.96 
132.05 
18.86 
207.31 
29.62 
potassium 
mg 
2000.00 
194.21 
9.71 
70.51 
3.53 
110.70 
5.53 
selenium 
µg 
55.00 
37.60 
68.36 
13.65 
24.82 
21.43 
38.97 
zinc 
mg 
10.00 
8.99 
89.91 
3.26 
32.64 
5.13 
51.25 
biotin 
µg 
50.00 
33.91 
67.82 
12.31 
24.62 
19.33 
38.66 
folic acid 
µg 
200.00 
235.10 117.55 
85.35 
42.68 
134.01 
67.00 
niacin 
mg 
16.00 
7.46 
46.64 
2.71 
16.93 
4.25 
26.59 
pantothenic acid 
mg 
6.00 
3.09 
51.57 
1.12 
18.72 
1.76 
29.39 
riboflavin 
mg 
1.40 
0.93 
66.40 
0.34 
24.11 
0.53 
37.85 
thiamin 
mg 
1.10 
1.20 108.68 
0.43 
39.46 
0.68 
61.95 
vitamin A 
µg 
800.00 
360.00 
45.00 
130.70 
16.34 
205.20 
25.65 
vitamin B12 
µg 
2.50 
1.44 
57.60 
0.52 
20.91 
0.82 
32.83 
vitamin B6 
mg 
1.40 
1.01 
72.02 
0.37 
26.15 
0.57 
41.05 
vitamin C 
mg 
80.00 
108.16 135.20 
39.27 
49.09 
61.65 
77.07 
vitamin D 
µg 
5.00 
18.00 360.00 
6.54 130.70 
10.26 205.20 
vitamin E 
mg 
12.00 
7.69 
64.10 
2.79 
23.27 
4.38 
36.54 
vitamin K 
µg 
75.00 
46.80 
62.40 
16.99 
22.65 
26.68 
35.57 
* = % recommended daily allowances