The Effects of Commercially Available High Protein Drink on Amino Acid Bioavailability and Recovery From Muscle Fatiguing Exercise in 18-45-year-old Male and Female Participants.
Phase: NA
Conditions: Healthy Participants
Sponsor: Anglia Ruskin University

 
 
 
 
Title of project:  
 
• 
BOLT Part A: The effects of commercially available high protein drink on amino acid 
bioavailability in 18-45-year-old male and female participants. 
 
• 
BOLT Part B: The effects of commercially available high protein drink on recovery from 
muscle fatiguing exercise in 18-45-year-old male and female participants. 
 
 
NCT Number: 
• TBC 
 
Date: 
• 01.2.25  
 

2 
 
PARTICIPANT INFORMATION SHEET 
Please take the time to review this document and ask any questions you may 
have about the study before volunteering to take part. 
Section A:  The Research Project 
 
1. 
Title of project: BOLT Part A: The effects of commercially available high protein drink on amino 
acid bioavailability in 18-45-year-old male and female participants. 
 
2. 
Purpose of study 
 
Part A of the BOLT study will focus on characterising the total and essential amino acid 
concentrations for 4 hours following the consumption of a single serving of: 1) commercially 
available high-protein yoghurt drink, 2) a micellar casein drink, and 3) a flavoured water-based 
placebo drink. This is called a bioavailability study.  
 
The results will provide novel insights into protein sources and may enable future application in 
products available to the consumer. Therefore, the main aim of this study is to compare changes 
in blood proteins (amino acids) following the consumption of a high protein yoghurt drink to a 
micellar casein drink and a flavoured water-based placebo drink. 
 
This research study is being undertaken by Anglia Ruskin University, in Cambridge in 
collaboration with a nutrition company, Danone Global Research & Innovation Center, in the 
Netherlands.  
 
3. 
Who is the researcher?  
 
This project is led by Dr Ash Willmott with support from Dr Sanjoy Deb and the research team 
at the Cambridge Centre for Sport and Exercise Sciences at Anglia Ruskin University. 
 
4. 
Why have I been asked to participate? 
 
You are invited to participate in this research study based on your interest in the area and as a 
generally healthy adult. Before you decide whether to do so, it is important that you understand 
the research that is being undertaken and what your involvement will include. Please take the 
time to read the following information carefully and discuss it with others if you wish. Feel free 
to ask us anything that needs to be clarified or for any further information that will help make 
your decision. Please take your time to decide whether or not you wish to take part. Thank you 
for reading this.   
 
There are a number of key inclusion criteria listed below; please check that all apply to you: 
 
Inclusion criteria 
• 
Age ≥ 18 and ≤ 45 years. 
• 
Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2 (measured at the first assessment). 
• 
Written informed consent (undertaken at the first assessment). 
• 
Willingness and ability to comply with the protocol in the opinion of the 
investigator. 
• 
Judged by the investigator to be in good health as assessed by a health 
screening questionnaire. 
• 
Currently identifies as the same biological sex as at birth. 
 

3 
 
As with any study, there are also important exclusion criteria which will prevent you from being 
able to take part in this study – please check that none of these apply to you. Unfortunately if 
any criteria apply to you, you will be unable to participate in this research study.  
 
Exclusion criteria: 
• 
Any known ongoing medical condition that might interfere with absorption and 
digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel 
disease, gastroesophageal reflux disease, celiac disease, diaphragmatic 
hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, 
pancreatitis, GI cancer, oesophageal and/or gastric surgery). 
• 
Known musculoskeletal or soft tissue injury. 
• 
Known cardiovascular disease, disease related to the immune system and/or 
the respiratory system.  
• 
Known renal or hepatic failure or known thyroid dysfunction. 
• 
Known Diabetes Mellitus type I or type II, insulin resistance or metabolic 
syndrome. 
• 
Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment.  
• 
Known anaemia or low haemoglobin or low iron status.  
• 
Any known bleeding disorder or reaction to withdrawal of blood samples. 
• 
Use of oral and systemic use of prokinetics, laxatives, antidiarrheals, 
anticoagulants within 2 weeks prior to screening. 
• 
Use of systemic antibiotics within 4 weeks prior to screening. 
• 
Any known dietary allergies. 
• 
Any known intolerances to ingredients of the study product, i.e. dairy, cow’s 
milk allergies or lactose intolerance. 
• 
Self-reported adherence to a strict dietary regime (e.g. vegetarian/ vegan/ 
paleo/ketogenic/intermittent fasting/ high protein diet (>1.6 g/kg body 
weight/day), or protein supplementation or a weight loss program, as confirmed 
via the screening process. 
• 
Use of any nutritional supplements or additional protein supplements or 
nutritional support within 4 weeks prior to screening. 
• 
Engage (on average) in more than 2 resistance exercise sessions and/or more 
than 4 exercise sessions in total weekly within 2 months before screening. 
• 
Considered as endurance trained, competitive athletes or trained weightlifters, 
powerlifters or bodybuilders, in the opinion of the investigator. 
• 
Known pregnancy and/or lactating,  
• 
Current smoking or stopped smoking for <1 month prior to screening (except 
for incidental smoking of ≤3 cigarettes/cigars/pipes per week on average in the 
last month). 
• 
Average alcohol use of >21 glasses* per week for men or >14 glasses per week 
for women (on average during the last 6 months) or drug/ medicine abuse in 
opinion of the investigator, 
• 
Participation in any other clinical study with investigational or marketed 
products concomitantly or within 4 weeks before screening, 
• 
Major medical or surgical event requiring hospitalization within the preceding 3 
months and/or scheduled in the period of study participation relevant in the 
opinion of the investigator.  
 
Note: *1 glass of alcohol is a standard serving per type of alcohol. According to the 
Centres for Disease Control and Prevention 1 drink is defined as 340 ml of 5% ABV 
beer, 142 ml of 12% ABV wine, 43 ml of 40% ABV distilled spirits or liquor. 
 
 

4 
 
5. 
How many people will be asked to participate? 
 
Approximately 12 people will be invited to participate in this part of the study.  
 
6. 
Do I have to take part? 
 
Participation is completely voluntary, and you have the right to withdraw at any time without 
providing reason or judgment. To withdraw, please use the form at the bottom of the consent 
form provided or contact the Principal Investigator - Dr Ash Willmott via email: 
ash.willmott@aru.ac.uk.  
 
7. 
Has the study got ethical approval?  
 
This study has been approved by the Faculty of Science and Engineering Research Ethics 
Committee, Anglia Ruskin University. 
 
8. 
Has the organisation where the research is being carried out given permission? 
Yes, the project will be predominantly undertaken at Anglia Ruskin University, with the analysis 
of amino acids undertaken at the Danone Global Research & Innovation Center site (project 
funder).  
 
9. 
Legislation relating to this study 
 
In this study, whole blood samples will be collected via cannulation by a trained researcher or 
phlebotomist (i.e. blood collector). The serum part of the whole blood samples will then be 
transferred into 2 separate tubes (Sample 1 and Sample 2), before being frozen and stored in 
accordance with the Human Tissue Act (2004) at Anglia Ruskin University, Compass House 
010b and/or the Human Biomarker Laboratory. Upon completion of the data collection period, 
all Sample 1 tubes will be shipped to the Analytical Laboratory Danone Global Research & 
Innovation center, Utrecht, the Netherlands, for storage and the analysis of the amino acid 
bioavailability. All Sample 2 tubes will continue to be stored at Anglia Ruskin University, 
Compass House 010b and/or the Human Biomarker Laboratory. Upon the completion and 
confirmation of amino acid bioavailability analysis at the Analytical Laboratory Danone Global 
Research & Innovation center, Utrecht, the Netherlands, all material/samples, whether used or 
unused, will be disposed of in accordance with local legislation for both Sample 1 and Sample 
2.  
 
 
10. 
What will happen to the results of the study?  
 
If you agree to take part, your data will be password-protected and pseudo-anonymised via a 
coding system known only by the research team. Your results will be stored on a password-
protected computer and portable disk drive, and your name and other details will be removed. 
All paper data will be kept securely by the research team at Anglia Ruskin University. The 
average data for all participants will be used for research purposes only, e.g., research 
publications or conference presentations, with no reference to individual personal information 
(names, contact details etc.). 
 
11. 
Contact for further information  
 
For further information, please do not hesitate to contact the lead researcher: 
ash.willmott@aru.ac.uk. 

5 
 
Section B:  Your Participation in the Research Project 
 
1. 
What will I be asked to do? 
 
This study has two parts: 1) an initial pre-screening assessment and 2) complete 3 separate 
trials where you will be asked to ingest a nutritional test or control product drink. All lab-based 
sessions will take place at Compass House on East Road, Anglia Ruskin University, Cambridge.  
 
The study design is a three-way, single-blind, randomised, cross-over study design for 
bioavailability assessment of the amino acid profile of 3 nutritional drinks as outlined below, 
whereby you will receive either 1 serving of the: 
• 
Test product: high protein yoghurt drink (1 serving = 25g protein, 300ml),  
• 
Control product 1: micellar casein drink (1 serving = 25g protein, 300 ml),  
• 
Control product 2: flavoured water-based placebo drink (1 serving = 0g protein, 300 
ml), at each visit, in a randomised order. 
 
Part 1 – Pre-screening assessment:  
• 
This will involve a full study briefing presentation, in which we will go over the outline of 
the study, including expectations, lab visits and product information. 
• 
Study staff will collect food and exercise diaries from volunteers (a 3-day food and 
exercise diaries, comprising of 1 weekend day, 1 rest day, and 1 exercise day within a 
week). If the inclusion criteria are met, participants will continue into the trial.  
• 
Once you have had a chance to ask any questions and should you wish to volunteer, we 
will ask you to complete 2 consent forms (one for the main study and one for collection 
of samples as part of our internal processes). 
• 
Next, we will check you meet our study criteria via a standard health screen form as 
outlined above, along with assessment of your body composition, body mass and height 
(for body mass index). We will also collect data including, biological sex at birth 
(male/female), age (years) and lifestyle parameters (alcohol consumption is classified as 
[on average during the last 6 months] none, ≤ 7 units per week, 8-14 units per week, 15-
21 units per week, > 21 units per week, training history including amount of exercise 
undertaken per week/month [time and frequency] and general information from the 
health screen questionnaire, and then relevant medical history, prior and concomitant 
medication, and nutritional supplements. If exclusion criteria are met, participants will be 
withdrawn from the study.  
• 
Assuming you fully meet our criteria and are willing to take part, we will then provide you 
with key information and instructions for food diary assessment. 
• 
Following this first assessment, we will then provide you with details to book in for each 
of the 3 trials. 
 
 
 

6 
 
Part 2 - Main study trials: 
The main part of this study will involve 3 visits of >4 hours each, with each visit scheduled no 
more than 21 days apart.  
 
Outline of each visit 
 
General – 
You will be required to refrain from physical activity and alcohol consumption 24 hours before 
each study visit. The evening before the lab visit, you will be asked to eat a standardised meal 
to be consumed after 17:00 and arrive the labs after an overnight fast (at least 10 hours). Before 
arriving at the lab (~7-9am), you can drink up to 500 mL of only water in the morning, but no 
sooner than 1 hour before each appointment. You will also be required to complete a habitual 
food diary which will be explained at the briefing session. At the end of each visit, we will 
undertake product/protocol compliance audits to assess study product intake and adherence to 
assessment windows during the study visits. 
 
Visit 1 – Upon arrival we will assess your morning body mass. A member of the research team 
will then fit an intravenous cannula via a short scratch, using a butterfly needle (which is a short, 
flexible tube that is placed into a vein on your arm or back of your hand) and withdraw 10 mL of 
blood as a baseline sample. You will then be asked to consume of 1 of 3 drinks (as outlined 
above), where you will have up to 10 mins to drink the assigned drink. Blood samples will then 
be drawn at time intervals including 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min after the 
study product intake. This will equate to 11 samples of 10 mL blood collection (within 2 x 5 mL 
tubes per timepoint), which equals 110 mL blood collection in total per visit (or 330 mL in total 
over the study). Per trial (110 mL of blood collection) and also over the course of the study (330 
mL of blood collection), the amount of blood drawn is less than the maximum permitted extra 
corporeal volume for male (552-971 mL) and female (486-908 mL) donors of varying body 
masses and heights (50-100kg, 150-183 cm; JPAC, 2013). 
 
This constitutes the ‘bioavailability’ test for this study. We will ask you to rest comfortably (please 
bring something to read or a laptop). Throughout the study visits, you will not be able to eat, but 
will be permitted to drink water ad libitum after the first 2 hours (with a maximum of 250 mL) – 
the volume consumed at visit trial 1 will be replicated on subsequent visits. In addition, you will 
be asked to abstain from any physical exercise other than incidental walking during the study 
visits. 
 
Visits 2 and 3 – will be at least 5 days apart but no more than 21 days between a visit; you will 
undergo the same protocol method as outlined above, with a different study product. 
 
About the nutrition products we will assessing: 
This study is a project being undertaken between Anglia Ruskin University and Danone Global 
Research & Innovation Center, Netherlands. All products will be supplied independently by 
Danone Global Research & Innovation Center as a nutrition company and have been verified for 
human consumption and safety. All ingredients are commonly found in food, with the main test 
product available in supermarkets. For the purposes of this study, we will be using 3 different 
products in a random order: 
 
• 
Test product: high protein yoghurt drink (1 serving = 25g protein, 300ml) that is found 
in supermarkets throughout the UK,  
• 
Control product 1: micellar casein drink (1 serving = 25g protein, 300 ml), which is a 
protein supplement that is the predominant protein in cow’s milk.   
• 
Control product 2: flavoured water-based placebo drink (1 serving = 0g protein, 300 
ml), 
 

7 
 
What are my samples being assessed for? 
We will collect blood samples and analyse them only for the markers listed below. We will be 
assessing your amino acids (the building blocks of proteins) in your blood in response to the test 
drink. Whilst you don’t need to worry about all the names, we have listed them here for 
completeness:  
• 
Essential Amino Acids (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, 
threonine, tryptophan, and valine), 
• 
Total Amino Acids (alanine, arginine, asparagine, aspartic acid, citrulline, cysteine, 
glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, 
ornithine, phenylalanine, serine, taurine, threonine, tryptophan, tyrosine, valine, and 
proline) 
 
These markers will be assessed at Danone Global Research & Innovation Center, 
Netherlands. All samples count as ‘human tissue’ and will therefore be collected, stored and 
disposed of in accordance with the Human Tissue Act (HTA: 2004) and internal processes at 
Anglia Ruskin University and Danone Global Research & Innovation Center, Netherlands, 
respectively. All samples will be pseudo-anonymous and stored under the participant ID code. 
Only the research team can access the information linking the participant ID and individual. 
This information will be kept on a secure, password-protected ARU laptop and will not be 
shared with anyone else. All signed consent forms will be kept in a locked cabinet located in a 
restricted-access office. 
 
Finally, participants will be contacted within 7 days after completion of the study to follow up 
on any Serious Adverse Events that may have occurred – e.g. incidence, frequency, 
seriousness, severity, and relatedness of any product/method undertaken as part of the study. 
 
2. 
In relation to this specific research project, we need to make you aware of the following: 
 
☐ 
We do not need your personal data at any stage of this research project 
We are responsible for the personal data you give to us as a: 
X 
Data Controller 
(We are in sole control over the 
research) 
Who are we?: 
Dr Ash Willmott 
Dr Sanjoy Deb  
Mr Dirk Dugdale 
Anglia Ruskin University 
X 
Joint Controller 
(Where 
ARU 
and 
another 
organisation 
are 
working 
together on research) 
with: 
Danone Global Research & 
Innovation Center. 
☐ 
Data Processor (Where the 
data will belong to another 
organisation and ARU is being 
engaged 
under 
contract/ 
agreement 
to 
conduct 
the 
research 
and 
provide 
an 
outcome but has no rights over 
the personal data)  
 
on behalf of: 
 
 
 
 
 
 
 

8 
 
3. 
I will be asking you for the following information: 
 
Personal Data 
Sensitive Personal data 
✓ 
Name / Contact details 
(email address) 
☐ 
Image (Photo or video) 
✓ 
Racial/ Ethnicity 
data 
✓ 
Age 
☐ 
Experiences  
☐ 
Political/ Religious 
beliefs 
☐ 
Location data 
☐ 
Opinions  
☐ 
Trade Union 
membership 
☐ Employment & Earnings 
✓ 
Serum amino acids 
☐ Genetic/ Biometric 
data 
☐ ID Numbers (e.g. NHS) 
☐ 
[Other] 
✓ 
Health data as 
outlined below 
☐ 
Online identifier 
 ☐ 
 
[Other] 
☐ 
Sex life/ orientation 
data 
 
The health data we intend to collect will include: 
o Demographics 
• 
Biological sex at birth (male/female), 
• 
Age (years). 
o Anthropometry 
• 
Height (m) via SECA scale, 
• 
Body mass (kg) via SECA scale, 
• 
Lean tissue mass (kg) and fat mass (kg and % body mass) using 
Bod Pod, 4-site skinfold thickness and/or Bioelectrical Impedance 
scales, 
• 
BMI (kg/m2) via equation: dividing body mass (kg) by height (m2). 
o Lifestyle parameters 
• 
Alcohol consumption is classified as (on average during the last 6 
months) none, ≤ 7 units per week, 8-14 units per week, 15-21 units 
per week, > 21 units per week, 
• 
Training history including amount of exercise undertaken per 
week/month (time and frequency).  
• 
General information from the health screen questionnaire, and then 
relevant medical history, prior and concomitant medication, and 
nutritional supplements. 
• 
Participants will be asked to complete a 3-day food and exercise 
diaries, comprising of 1 weekend day, 1 rest day, and 1 exercise 
day within a week. 
o Serum amino acids 
• 
Essential Amino Acids (histidine, isoleucine, leucine, lysine, 
methionine, phenylalanine, threonine, tryptophan, and valine), 
• 
Total Amino Acids (alanine, arginine, asparagine, aspartic acid, 
citrulline, cysteine, glutamic acid, glutamine, glycine, histidine, 
isoleucine, leucine, lysine, methionine, ornithine, phenylalanine, 
serine, taurine, threonine, tryptophan, tyrosine, valine, and proline) 
 
 

9 
 
4. 
What will happen to your data? 
 
All data, samples and information collected from you as part of this study will be pseudo-
anonymous and stored under the participant ID code, current legislation and Anglia Ruskin 
University policy. Only the research team can access the information linking the participant ID 
and individual. This information will be kept on a secure, password-protected ARU laptop and 
will not be shared with anyone else. All signed consent forms will be kept in a locked cabinet 
located in a restricted-access office.  
 
Serum blood samples (Sample 1 and Sample 2), will be frozen and stored in accordance with 
the Human Tissue Act (2004) at Anglia Ruskin University, Compass House 010b and/or the 
Human Biomarker Laboratory. Upon completion of the data collection period, all Sample 1 tubes 
will be shipped to the Analytical Laboratory Danone Global Research & Innovation center, 
Utrecht, the Netherlands, for storage and the analysis of the amino acid bioavailability. All 
Sample 2 tubes will continue to be stored at Anglia Ruskin University, Compass House 010b 
and/or the Human Biomarker Laboratory. Upon the completion and confirmation of amino acid 
bioavailability analysis at the Analytical Laboratory Danone Global Research & Innovation 
center, Utrecht, the Netherlands, all material/samples, whether used or unused, will be disposed 
of in accordance with local legislation for both Sample 1 and Sample 2. The study will be written 
up using the information and data collected as part of a research publication in a scientific 
journal.  
 
5. 
Will I be reimbursed travel expenses?  
 
No – we unfortunately will not fund travel expenses for this study. 
 
6. 
Will I receive any payment to take part in the research?  
 
Yes – participants will receive food vouchers (£45 in total) to undertake recommended diets over 
testing period. This includes 3 standardised dinners which are to be consumed after 17:00 the 
evening prior to each study visit. These vouchers will be used within regular supermarkets (e.g. 
Tesco) for the purchasing of the recommended diets. Support, information and guidance will be 
provided to the participants for the recommended diets.  
 
In addition, upon completion of all 3 trials there is an individual subsidy of £75 Amazon vouchers 
per person based on the recognised commitment for this study. 
 
7. 
Are there any possible disadvantages or risks to taking part?   
 
Research of this nature has a number of potential risks. However, every effort has been made 
to minimise the nature of these risks and ensure your wellbeing. Risk assessments have been 
carried out for all procedures in this study. Whilst we highlight the exclusion criteria above and 
key risks associated with this study below, we would also like to remind/bring these points to the 
reader’s attention here when considering their participation for this study –  
 
1) Any participants with known dietary allergies will be excluded. 
2) Any participants with known intolerances to ingredients of the study product, i.e. 
dairy, cow’s milk allergies, lactose intolerance, will be excluded. 
3) Participants with distress/fears/negative experience or unsure/uncertain on the 
associated requirements for blood samples and use of needles and/or cannulas, will 
be excluded.  
 
Possible risks associated with this study include: 
• 
Blood collection - possible risks include: dizziness/fainting/ nausea, localised 
bruising/swelling and contamination/infection. Samples will only be collected by qualified 

10 
 
researchers who are highly experienced in taking blood samples. Only in-date, sterilised, 
equipment will be used. 
 
• 
Nutrition products - with any nutrition product, the following risks are possible albeit 
unlikely: contamination of products, acute side effects (nausea, dizziness, bloating 
and/or gastrointestinal distress from consumption) or allergic or adverse reaction to the 
product. Products will only be sourced from a nutrition company for safe public 
consumption. Should you experience any adverse reactions to either food product, 
please advise the researcher or principal investigator immediately (Dr Ash Willmott). 
 
• 
General data – there is the risk of ‘disclosure of personal information’; however, this is 
very unlikely as confidentiality will be maintained for all participants throughout the study 
using number coding instead of personal details. All data associated with this study will 
be password protected and fully anonymised for confidentiality. 
 
 
8. 
What are the likely benefits of taking part?   
 
Whilst this type of research will be used to support/design future studies on recovery strategies 
and the product’s efficacy, we will be providing you with information pertinent to your dietary 
analysis, which you might find useful to your day-to-day lifestyle. Once all the data has been 
compiled, we will share your individual data with you which will let you know more about how 
you responded to the nutritional drinks.  
 
9. 
Can I withdraw at any time, and how do I do this?   
 
You can withdraw from the study at any time and without giving a reason. Should you decide to 
withdraw from the study during or following your participation for any reason, please contact the 
researcher or principle investigators via email - Dr Ash Willmott: ash.willmott@aru.ac.uk. 
 
10. 
What will happen to my data? 
 
Our general privacy notice explaining our use of your personal data for research purposes is 
available here: 
 
https://www.anglia.ac.uk/privacy-and-cookies/research-participants  
 
Please visit this link for information about how long we keep your data, how we keep it secure, 
how you can exercise your rights over your data, and how you can make a complaint about our 
use of your data. 
 
11. 
Can I withdraw my data from the study? 
 
If you wish to withdraw from the research, please speak to the researcher or email them at 
ash.willmott@aru.ac.uk stating the title of the research or send them this withdrawal slip. You 
do not have to give a reason for why you would like to withdraw. Please let the researcher know 
whether or not you are happy for the data collected so far to be used in the research.  You are 
completely free to ask for any data to also be removed should you wish it to be, if the data is not 
anonymised. When data is anonymised upon full data collection (estimated November 2025), it 
means personal data relating to it has been permanently removed, so the researcher will not 
know which belongs to you. You do not have to answer any questionnaire or interview questions 
you do not wish to. 
 
 
 

11 
 
12. 
Whether there are any special precautions you must take before, during or after taking 
part in the study 
 
As outlined above, before each laboratory visit, you will be required to consume a standardised 
meal, which will be provided and outlined at the pre-screening assessment, which needs to be 
consistent prior to all lab visits. You will be asked to refrain from physical activity and alcohol 
consumption 24 hours before each study visit. You will also need to overnight fast (10 hours), 
consuming only water (up to 500 mL) no less than 1 hour before arrival for testing and avoid the 
consumption of any stimulants or protein formulas which may conflict with the study parameters 
(e.g. caffeine, energy drinks or whey protein shakes). If your health status changes, or you start 
taking medication or other supplements during the study, please let us know as soon as 
possible.   
 
13. 
Will I pass onto anyone else what you have told me? 
 
The only people who will be able to access your data (as outlined above), will be the principal 
investigator (Dr Ash Willmott) and members of the immediate research team, as well as Danone 
Global Research & Innovation Center. All data will be pseudo-anonymised and so your name 
will not be stored or shared. Only the immediate research team will have access to participants 
names and ID codes. This will not be shared any further.  
 
14. 
Summary of research findings 
 
A summary of the research findings will be available and can be provided to you, if you wish, 
after the study is completed. This can be arranged after the study is completed. The summary 
of research findings can be sent to you via email.  
 
15. 
Contact details for complaints 
 
If you have any complaints about the study, please contact ash.willmott@aru.ac.uk in the first 
instance. There are also, however, details about ARU’s complaints procedure should you wish 
to use it. Email address: complaints@aru.ac.uk. Postal address: Office of the Secretary and 
Clerk, Anglia Ruskin University, Bishop Hall Lane, Chelmsford, Essex, CM1 1SQ. 
 
Version control = Date 01.2.25 V1.2 
Your participant information sheet, consent form and other documents should have a version 
number and date. This is in order that should any changes be required by the ethics committee, 
it is clear which documentation has ethical approval.  
 
 

12 
 
PARTICIPANT CONSENT FORM 
 
 
 
 
Th 
 
NAME OF PARTICIPANT: 
 
Title of the project: BOLT STUDY Part A: The effects of commercially available high protein 
drink on amino acid bioavailability in 18-45-year-old male and female participants 
 
Main investigator and contact details: Dr Ash Willmott (ash.willmott@aru.ac.uk)  
 
Members of the research team: Dr Sanjoy Deb, Mr Dirk Dugdale.  
 
1. 
I agree to take part in the above research. I have read the Participant Information Sheet 
(Date 01.02.25 V2) for the study. I understand what my role will be in this research, and 
all my questions have been answered to my satisfaction. 
 
2. 
I understand that I am free to withdraw from the research at any time, without giving a 
reason. To do this I understand I can use the withdrawal slip below or email the main 
investigator. 
 
3. 
I understand I am free to ask any questions at any time before and during the study. 
 
4.  
I understand what information will be collected from me for the study. 
 
5. 
I understand what will happen to the data collected from me for the research. All blood 
samples will be collected, analysed and disposed of in accordance with the Human 
Tissue Act. 
 
6.  
For the purposes of the General Data Protection Regulation (2018), if this project 
requires me to produce personal data, I have read and understood how Anglia Ruskin 
University will process it. 
 
7.  
I have been told about any disadvantages or risks regarding me taking part.  
 
8.   
I have been informed how my data will be processed, how long it will be kept and when 
it will destroyed.  
 
9.  
I have been provided with a copy of this form and the Participant Information Sheet (Date 
01.02.25 V2). 
 
 
Name of participant (print)………………………… 
 
Signed………………..…. 
 
Date……………… 
 
 
 
 
 
 
 
 
 

13 
 
I WISH TO WITHDRAW FROM THIS STUDY. 
 
Title of the project: BOLT STUDY: The effects of commercially available high protein drink 
on amino acid bioavailability in 18-45-year-old male and female participants 
 
If you wish to withdraw from the research, please speak to the researcher or email 
them Dr Ash Willmott - ash.willmott@aru.ac.uk, stating the title of the research or send 
them this withdrawal slip. 
  
You do not have to give a reason for why you would like to withdraw. 
 
Date 01.02.25  
V2 
 
 

14 
 
PARTICIPANT INFORMATION SHEET 
Please take the time to review this document and ask any questions you may 
have about the study before volunteering to take part. 
Section A:  The Research Project 
 
12. 
Title of project: BOLT Part B: The effects of commercially available high protein drink on 
recovery from muscle fatiguing exercise in 18-45-year-old male and female participants. 
 
13. 
Purpose of study 
 
Part B of the BOLT study will examine the effect of a twice-daily ingestion of 1) high protein 
yoghurt drink (test product), or 2) flavoured water based drink (control drink) on biomarkers of 
1) muscle damage/stress, 2) physical function, 3) self reported pain and muscle soreness, and 
4) range of motion, sleep, and recovery assessments, at 24, 48, and 72 hours following acute 
muscle fatiguing exercise in 18-45-year-old male and female participants. Participants will be 
randomly allocated to the test product or control drink groups prior to beginning the first visit. 
 
The results will provide novel insights into the efficacy of protein drinks on markers of exercise 
and may enable future application in products available to the consumer. Therefore, the main 
aim of this study is to compare the effectiveness of the consumption of a high protein yoghurt 
drink to a flavoured water-based placebo drink on changes in blood biomarkers and markers of 
recovery 24, 48, and 72 hours after a fatiguing exercise protocol. 
 
This research study is being undertaken by Anglia Ruskin University, in Cambridge in 
collaboration with a world-leading nutrition company, Danone Global Research & Innovation 
Center, in the Netherlands.  
 
14. 
Who is the researcher?  
 
This project is being undertaken by Dr Ash Willmott, Mr Dirk Dugdale and Dr Sanjoy Deb at the 
Cambridge Centre for Sport and Exercise Sciences at Anglia Ruskin University. 
 
15. 
Why have I been asked to participate? 
 
You are being invited to take part in this research study based on your interest in the area and 
as a generally healthy adult. Before you decide whether to do so, it is important that you 
understand the research that is being undertaken and what your involvement will include. Please 
take the time to read the following information carefully and discuss it with others if you wish. Do 
not hesitate to ask us anything that is not clear or for any further information you would like to 
help you would like to help make your decision. Please do take your time to decide whether or 
not you wish to take part. Thank you for reading this.   
 
There are a number of key inclusion criteria listed below, please check that all apply to you: 
 
Inclusion criteria 
• 
Age ≥ 18 and ≤ 45 years. 
• 
Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2 (measured at the first assessment), 
• 
Written informed consent (undertaken at the first assessment). 
• 
Willingness and ability to comply with the protocol in the opinion of the 
investigator. 
• 
Judged by the investigator to be in good health as assessed by a health 
screening questionnaire. 
• 
Currently identifies as the same biological sex as at birth. 

15 
 
 
As with any study, there are also important exclusion criteria which will prevent you from being 
able to take part in this study – please check that none of these apply to you. Unfortunately, if 
any criteria apply to you, you will be unable to participate in this research study.  
 
Exclusion criteria: 
• 
Any known ongoing medical condition that might interfere with absorption and 
digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel 
disease, gastroesophageal reflux disease, celiac disease, diaphragmatic 
hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, 
pancreatitis, GI cancer, oesophageal and/or gastric surgery).), in opinion of the 
investigator, 
• 
Known musculoskeletal or soft tissue injury. 
• 
Known cardiovascular disease, disease related to the immune system and/or 
the respiratory system. 
• 
Known renal or hepatic failure or known thyroid dysfunction. 
• 
Known Diabetes Mellitus type I or type II, insulin resistance or metabolic 
syndrome. 
• 
Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment,  
• 
Known anaemia or low haemoglobin or low iron status.  
• 
Any known bleeding disorder or reaction to withdrawal of blood samples. 
• 
Use of oral and systemic use of prokinetics, laxatives, antidiarrheals, 
anticoagulants within 2 weeks prior to screening. 
• 
Use of systemic antibiotics within 4 weeks prior to screening. 
• 
Any known dietary allergies. 
• 
Any known intolerances to ingredients of the study product, i.e. dairy, cow’s 
milk allergies, lactose intolerance. 
• 
Self-reported adherence to a strict dietary regime (e.g. vegetarian/ vegan/ 
paleo/ketogenic/intermittent fasting/ high protein diet (>1.6 g/kg body 
weight/day), or protein supplementation or a weight loss program, as confirmed 
via the screening process. 
• 
Use of any nutritional supplements or additional protein supplements or 
nutritional support within 4 weeks prior to screening. 
• 
Engage (on average) in more than 2 resistance exercise sessions and/or more 
than 4 exercise sessions in total weekly within 2 months before screening, 
• 
Considered as endurance trained, competitive athletes or trained weightlifters, 
powerlifters or bodybuilders, in the opinion of the investigator. 
• 
Known pregnancy and/or lactating.  
• 
Current smoking or stopped smoking for <1 month prior to screening (except 
for incidental smoking of ≤3 cigarettes/cigars/pipes per week on average in the 
last month). 
• 
Average alcohol use of >21 glasses* per week for men or >14 glasses per week 
for women (on average during the last 6 months) or drug/ medicine abuse in 
opinion of the investigator. 
• 
Participation in any other clinical study with investigational or marketed 
products concomitantly or within 4 weeks before screening. 
• 
Major medical or surgical event requiring hospitalization within the preceding 3 
months and/or scheduled in the period of study participation relevant in the 
opinion of the investigator.  
 
Note: *1 glass of alcohol is a standard serving per type of alcohol. According to the 
Centres for Disease Control and Prevention 1 drink is defined as 340 ml of 5% ABV 
beer, 142 ml of 12% ABV wine, 43 ml of 40% ABV distilled spirits or liquor. 

16 
 
 
16. 
How many people will be asked to participate? 
 
For this part of the study, approximately 50 people will be invited to participate. Whilst this is an 
acute short-term study, it involves 4 visits of ~2 hours each, across 4 consecutive days, we are 
looking for reliable individuals who will be willing to complete all aspects of the study based on 
the nature of the project. 
 
17. 
Do I have to take part? 
 
Participation is completely voluntary, and you have the right to withdraw at any time without 
providing reason or judgment. To withdraw, please use the form at the bottom of the consent 
form provided or contact the Principal Investigator - Dr Ash Willmott via email: 
ash.willmott@aru.ac.uk.  
 
18. 
Has the study got ethical approval?  
 
This study has been approved by the Faculty of Science and Engineering Research Ethics 
Committee, Anglia Ruskin University. 
 
19. 
Has the organisation where the research is being carried out given permission? 
 
All research will be undertaken with approval from the Laboratory Director/Manager, within 
Anglia Ruskin University, Sport and Exercise Science Human Physiology Laboratory, Compass 
House, in Cambridge. In addition, this project will be carried out under human tissue authority 
regulations in compliance with university guidelines to ensure your blood samples collected 
within this study are kept confidential and secure. 
 
20. 
Legislation relating to this study 
 
In this study, 5 x 10 mL whole blood samples will be collected via venepuncture by a trained 
researcher or phlebotomist (i.e. blood collector) - twice on visit 2 and once on visits 3-5 (= 50 
mL of whole blood in total per participant). The amount of blood drawn is less than the maximum 
permitted extra corporeal volume for male (552-971 mL) and female (486-908 mL) donors of 
varying body masses and heights (50-100kg, 150-183 cm; JPAC, 2013). The serum/plasma part 
of the whole blood samples will then be transferred into separate tubes for each biomarker. We 
will be assessing 5 biomarkers in total - creatine kinase, cortisol, myoglobin, C-reactive protein 
and interleukin-6. For each serum/plasma tube there will be 2 separate samples = Sample 1 
and Sample 2, which will be frozen and stored in accordance with the Human Tissue Act (2004) 
at Anglia Ruskin University, Compass House 010b and/or the Human Biomarker Laboratory. 
Upon completion of the data collection period, all Sample 1 tubes will be analysed for muscle 
damage/inflammatory and stress biomarkers at Anglia Ruskin University or shipped to the Core 
Biochemical Assay Laboratory at Addenbrookes Hospital, Cambridge, UK, for storage and the 
analysis of the muscle damage/inflammatory and stress biomarkers. All Sample 2 tubes will 
continue to be stored at Anglia Ruskin University, Compass House 010b and/or the Human 
Biomarker Laboratory. Upon the completion of muscle damage/inflammatory and stress 
biomarker analysis at Anglia Ruskin University or the completion and confirmation of the muscle 
damage/inflammatory and stress biomarkers analysis at the Core Biochemical Assay Laboratory 
at Addenbrookes Hospital, Cambridge, UK, all material/samples, whether used or unused, will 
be disposed of in accordance with local legislation for both Sample 1 and Sample 2.  
 
 
 
 

17 
 
21. 
What will happen to the results of the study?  
 
If you agree to take part, your data will be password protected and pseudo-anonymised via a 
coding system known only by the lead researcher. Your results will be stored on a password 
protected computer and portable disk drive, with your name and other details removed. All paper 
data will be kept securely by the research team at Anglia Ruskin University. The average data 
for all participants will be used for research purposes only e.g. research publication or 
conference presentation, with no reference to individual personal information (names etc.). 
 
22. 
Contact for further information  
 
For further information, please do not hesitate to contact the lead researcher: 
ash.willmott@aru.ac.uk. 
Section B:  Your Participation in the Research Project 
 
3. 
What will I be asked to do? 
 
This study has two parts: 1) an initial pre-screening assessment and 2) complete 4 separate 
trials where you will be asked to ingest a nutritional test or control product drink. All lab-based 
sessions will take place at Compass House on East Road, Anglia Ruskin University, Cambridge.  
 
The study is an exploratory interventional study, utilising double blind, randomised, parallel 
group design for the assessment of a nutritional drink as outlined below on the recovery from 
acute muscle fatiguing exercise protocol. Participants will receive 2 servings of a Test product: 
high protein yoghurt drink (1 serving = 25g protein, 300 ml) or a Control product: flavoured 
water-based placebo drink (1 serving = 0g protein, 300 ml), per day for 3 days over the course 
of the study.  
 
Participants will receive a copy of this information on the study, to read over and decide upon 
their voluntary participation. If interest, participants will be requested to complete 3-day food and 
exercise diaries (as outlined/provided below), comprising of 1 weekend day, 1 rest day, and 1 
exercise day within a week before attending the pre-screening assessments where they will be 
asked to provide their consent for participation. 
 
Having read this form and followed the procedure above, we will ask you to attend a full study 
briefing and pre-screening assessment as follows: 
 
Visit 1: 
Part 1 – Pre-screening assessment:  
• 
This will involve a full study briefing presentation, in which we will go over the outline of 
the study, including expectations, lab visits and product information. Participants will 
refrain from physical activity and alcohol consumption 24 hours before the familiarisation 
visit.  
• 
Study staff will collect food and exercise diaries from volunteers. If the inclusion criteria 
are met, participants will continue into the trial.  
• 
Once you have had a chance to ask any questions and should you wish to volunteer, we 
will ask you to complete 2 consent forms (one for the main study and one for collection 
of samples as part of our internal processes). 
• 
Next, we will check you meet our study criteria via a standard health screen form as 
outlined above, along with assessment of your body composition, body mass and height 
(for body mass index). We will also collect data including, biological sex at birth 
(male/female), age (years) and lifestyle parameters (alcohol consumption is classified as 
[on average during the last 6 months] none, ≤ 7 units per week, 8-14 units per week, 15-

18 
 
21 units per week, > 21 units per week, training history including amount of exercise 
undertaken per week/month [time and frequency] and general information from the 
health screen questionnaire, and then relevant medical history, prior and concomitant 
medication, and nutritional supplements. If exclusion criteria are met, participants will be 
withdrawn from the study.  
• 
Assuming you fully meet our criteria and are willing to take part, we will then provide you 
with key information and instructions for food diary assessment. 
• 
Participants will then undergo familiarisation of the primary dependent measures and 
exercises (as outlined below) that will be completed during the study. Study staff will 
measure participants’ body mass and hydration status, and maximal voluntary 
contraction (MVC) of knee extension/flexion. Study staff will familiarise participants with 
the perceived pain threshold test, range of motion (ROM) test, 75% of MVC, drop jumps, 
30 second counter movement jump (CMJ30), and 6 second peak power test (PPT6).  
• 
Participants will be informed of the set standardised meals for breakfast, lunch and 
dinner across visit 2-5 and will be asked to keep their habitual physical activity pattern of 
no more than 4 exercise sessions per week, of which no more than 2 sessions are light 
resistance exercise sessions. Between visit 2-5 participants will be asked not engage in 
exercise, except for the exercise that is part of this study. Participants will record any 
deviations from the standardised meal plan in a food compliance diary throughout. 
• 
Participants will be randomly allocated to receive either the test product or the control 
product. 
• 
Following this first assessment, we will then provide you with details to book in for each 
of the 4 trials. 
 
Part 2 - Main study trials: 
The main part of this study will involve 4 visits of ~2 hours each, across 4 consecutive days, 
occurring at the same time of day.  
 
Outline of each visit 
 
General – Participants will be required to refrain from physical activity and alcohol consumption 
24 hours before each study visit. Participants will be asked to adhere to the recommended 
standardised meals for breakfast, lunch and dinner across visit 2-5. Between visit 2-5, 
participants will be asked not engage in exercise, except for the exercise that is part of this study. 
Participants will record any deviations from the standardised meal plan in a food compliance 
diary throughout. 
 
After an overnight fast (at least 10 hours) for each visit, participants will come to the study site 
to participate in the study visit. Before arriving to our lab, you can drink up to 500 mL of only 
water in the morning. You will also be required to complete a habitual food diary which will be 
explained at the briefing session. At the end of each visit, we will undertake product/protocol 
compliance audits to assess study product intake at the study visits and adherence to 
assessment windows. 
 
Visit 2 – Upon arrival to the laboratories, participants will be asked to provide their completed 
food compliance diary. Study staff will then measure participants body mass, hydration status 
and collect one 10 mL whole blood sample via venepuncture by a trained researcher or 
phlebotomist (i.e. blood collector). Participants will complete the sleep quality questionnaire, 
recovery questionnaires, perceived pain threshold test, record heart rate variability (HRV) and 
range of motion (ROM) test. Next, participants will complete maximal voluntary contraction 
(MVC), 75% of MVC, 30 second countermovement jump (CMJ30) test and a 6 second peak 
power output test (PPT6). Participants will then complete the muscle fatiguing exercise protocol 
(6 sets, whilst wearing a weighted vest) of 25 drop jumps, with passive rest between sets. Study 
staff will measure the participants’ rating of perceived exertion (RPE) and heart rate before, 

19 
 
during and after the protocol, as well as a capillary blood lactate concentration from the 
participants’ fingertip immediately before and after the protocol. Participants will then repeat the 
baseline protocol (e.g. blood sample, perceived pain threshold, ROM, MVC, CMJ30 and PPT6 
tests). Within 30-min after the acute muscle fatiguing exercise protocol, participants will consume 
the first serving of the study product at the site.  
 
Before leaving the study site, participants will receive recommendations for standardised meals 
for the next 3 days, the second serving of the study product, and study product compliance 
diaries. In the afternoon, participants will consume standardised lunch, test or control product 
and dinner (described below).  
 
Visit 3, 4 and 5 – On visit 3-5, participants will attend the laboratory once again and return 
completed food compliance diaries and study product intake compliance diaries from the 
previous day and receive the same empty diaries for the next day. On visit 3-5 study staff will 
again measure the participants’ body mass, hydration status and draw a 10 mL venous blood 
sample. Participants will then complete the sleep quality questionnaire, recovery questionnaire, 
perceived pain threshold test, record HRV and range of motion test. Next, participants will 
complete MVC, 75% of MVC, CMJ30, and PPT6 tests. Within 30-min testing, participants will 
consume the study product at the site. Participants will consume a standardised lunch, the 
second serving of the study product, and dinner at home. On visit 5, participants will end the 
study after the performance and fatigue measures followed by lunch. 
 
About the nutrition products we will assessing: 
This study is a major project being undertaken between Anglia Ruskin University and Danone 
Global Research & Innovation Center, in the Netherlands. All products will be supplied 
independently by Danone Global Research & Innovation Center as a world-leading nutrition 
company and have been verified for human consumption and safety. For the purposes of this 
study, there will be 2 parallel groups undertaking 1 of 2 different products: 
 
• 
Test product: high protein yoghurt drink (1 serving = 25g protein, 300 ml), 
• 
Control product: flavoured water-based placebo drink (1 serving = 0g protein, 300 ml) 
 
What are my samples being assessed for? 
For this study we will be collecting 5 x 10 mL blood samples – 2 x 10 mL per visit 2 and 1 x 10 
mL per visits 3-5. We will only be analysing for the markers listed below.  
 
• 
Venous blood for muscle damage/stress biomarkers – creatine kinase, cortisol, 
myoglobin, C-reactive protein and interleukin-6. 
 
We will also be collecting 2 x fingertip capillary blood for metabolic changes pre-to-post 
exercise. This sample will be analysed for blood glucose and lactate at the point of collection 
and immediately disposed of. 
 
These markers will be assessed at Anglia Ruskin University or Addenbrookes hospital Core 
Biochemical Assay Laboratory, Cambridge (for venous blood) and ARU laboratories (for 
capillary blood). The samples you provide count as ‘human tissue’ and will therefore be 
collected, stored and disposed of in accordance with the human tissue act and our internal 
processes here at Anglia Ruskin University. All samples are coded (only known to the research 
team) so it will not be possible to identify you specifically. 
 
Finally, participants will be contacted within 7 days after completion of the study to follow up 
on any Serious Adverse Events that may have occurred– e.g. Incidence, frequency, 
seriousness, severity, and relatedness of any product/method undertaken as part of the study. 
 
 

20 
 
 
4. 
In relation to this specific research project, we need to make you aware of the following: 
 
☐ 
We do not need your personal data at any stage of this research project 
We are responsible for the personal data you give to us as a: 
☐ 
Data Controller 
(We are in sole control over the 
research) 
Who are we?: 
Dr Ash Willmott 
Dr Sanjoy Deb  
Mr Dirk Dugdale 
Anglia Ruskin University 
 
Blood sampling only:  
Anglia Ruskin University or 
Addenbrookes 
hospital 
Core 
biochemical 
assay 
laboratory 
X 
Joint Controller 
(Where 
ARU 
and 
another 
organisation 
are 
working 
together on research) 
with: 
Danone Global Research & 
Innovation Center, in the 
Netherlands 
 
 
☐ 
Data Processor (Where the 
data will belong to another 
organisation and ARU is being 
engaged 
under 
contract/ 
agreement 
to 
conduct 
the 
research 
and 
provide 
an 
outcome but has no rights over 
the personal data)  
 
on behalf of: 
 
 
16. 
I will be asking you for the following information: 
 
Personal Data 
Sensitive Personal data 
✓ 
Name/ Contact details 
(email address) 
☐ 
Image (Photo or video) 
✓ 
Racial/ Ethnicity 
data 
✓ 
Age 
☐ 
Experiences  
☐ 
Political/ Religious 
beliefs 
☐ 
Location data 
☐ 
Opinions  
☐ 
Trade Union 
membership 
☐ Employment & Earnings 
✓ 
Exercise test data as 
outlined below 
☐ Genetic/ Biometric 
data 
☐ ID Numbers (e.g. NHS) 
☐ 
[Other] 
✓ 
Health data as 
outlined below 
☐ 
Online identifier 
 ☐ 
 
[Other] 
☐ 
Sex life/ orientation 
data 
 
 
 

21 
 
The health data we intend to collect will include: 
o Demographics 
• 
Biological sex at birth (male/female), 
• 
Age (years). 
o Anthropometry 
• 
Height (m) via SECA scale, 
• 
Body mass (kg) via SECA scale, 
• 
Lean tissue mass (kg) and fat mass (kg and % body mass) using 
Bod Pod, 4-site skinfold thickness and/or Bioelectrical Impedance 
scales, 
• 
BMI (kg/m2) via equation: dividing body mass (kg) by height (m2). 
o Lifestyle parameters 
• 
Alcohol consumption is classified as (on average during the last 6 
months) none, ≤ 7 units per week, 8-14 units per week, 15-21 units 
per week, > 21 units per week, 
• 
Training history including amount of exercise undertaken per 
week/month (time and frequency).  
• 
General information from the health screen questionnaire, and then 
relevant medical history, prior and concomitant medication, and 
nutritional supplements. 
o Product/Protocol Compliance 
• 
Study product intake at the study visits,  
• 
Adherence to assessment windows. 
 
The exercise test data we intend to collect will include: 
 
o The change from baseline in peak torque [Nm] assessed by isometric/isokinetic 
maximum voluntary contraction (MVC) of knee extension/flexion at 120 
degrees/second using an isokinetic dynamometer,  
o The change from baseline in the number of repetitions to failure assessed by 
75% of isokinetic MVC of knee extension/flexion using an isokinetic 
dynamometer,  
o The change from baseline in relative mean power [W/kg of body mass] and 
fatigue index [n/%] assessed by countermovement jumps for 30s (CMJ30), 
o The change from baseline in a peak power output [W], fatigue index [%] and 
time to reach peak power [s] assessed by the 6-second peak power test (PPT6) 
on a cycle ergometer, 
o The change from baseline in perceived recovery [score] assessed using the 
Perceived Recovery Status (PRS) scale and visual analogue scale to evaluate 
fatigue severity (VAS-F), 
o The change in subjective pain (DOMS) as assessed by a visual analogue over 
time between and within the two groups, 
o The change from baseline in blood biomarker concentrations 
o serum/plasma CK concentration [IU/L or another unit],   
o serum/plasma myoglobin concentration [ng/mL or another unit], 
o serum/plasma interleukin-6 (IL-6) concentration [pg/mL or another unit], 
o serum/plasma C-reactive protein (CRP) concentration [mg/L or another 
unit], 
o serum/plasma cortisol [nmol/L or another unit], 
o Change from baseline in main muscle group and total perceived pain threshold 
[kgf] assessed using an algometer, 
o Change from baseline in stiffness and mobility [°flexion] of the knee extensors 
of the dominant leg assessed by ROM using a goniometer, 
o The change from baseline in sleep quality via the Consensus Sleep Diary.  

22 
 
o Heart rate variability (HRV). 
o Heart rate, RPE and blood lactate/glucose pre, during and after the fatiguing 
protocol.  
 
17. 
What will happen to your data? 
 
Any information/data collected from you as part of the study will pseudo-anonymised and stored 
in accordance with current legislation and Anglia Ruskin University policy. The serum and 
plasma part of the whole blood samples will be transferred into 2 separate tubes (Sample 1 and 
Sample 2), before being frozen and stored in accordance with the Human Tissue Act (2004) at 
Anglia Ruskin University, Compass House 010b and/or the Human Biomarker Laboratory. Upon 
completion of the data collection period, all Sample 1 tubes will be analysed for muscle 
damage/inflammatory and stress biomarkers at Anglia Ruskin University or shipped to the Core 
Biochemical Assay Laboratory at Addenbrookes Hospital, Cambridge, UK, for storage and the 
analysis of the muscle damage/inflammatory and stress biomarkers. All Sample 2 tubes will 
continue to be stored at Anglia Ruskin University, Compass House 010b and/or the Human 
Biomarker Laboratory. Upon the completion of muscle damage/inflammatory and stress 
biomarker analysis at Anglia Ruskin University or the completion and confirmation of the muscle 
damage/inflammatory and stress biomarkers analysis at the Core Biochemical Assay Laboratory 
at Addenbrookes Hospital, Cambridge, UK, all material/samples, whether used or unused, will 
be disposed of in accordance with local legislation for both Sample 1 and Sample 2. The study 
will be written up using the information and data collected as part of a research publication in a 
scientific journal. It will not be possible to identify individual participants from any outputs. As 
part of the study collaboration with Danone Global Research & Innovation Center, in the 
Netherlands, essential data will be shared with the Clinical Nutrition Team, generically, i.e. it will 
not be possible to identify you personally in any of the datasets.  
 
18. 
Will I be reimbursed travel expenses?  
 
No. 
 
19. 
Will I receive any payment to take part in the research?  
 
Yes – Participants will receive food vouchers (£120 in total) to undertake recommended diets 
over the 4 day testing period: Breakfast x 1, Lunch x 4, Dinner x 4. These vouchers will be used 
within regular supermarkets for the purchasing of the recommended diets. Support, information 
and guidance will be provided to the participants for the recommended diets. On completion of 
the study, participants will also receive a gift voucher (£100) as an incentive for participation. 
Time will be allocated to understand participation, to answer questions and discuss these 
incentives. 
 
20. 
Are there any possible disadvantages or risks to taking part?   
 
Research of this nature has a number of potential risks, however every effort has been made to 
minimise the nature of these risks and ensure your wellbeing. Risk assessments have been 
carried out for all procedures in this study.  
Whilst we highlight exclusion criteria above and key risks associated with this study below, we 
would also like to remind/bring these points to the readers attention here when considering their 
participation for this study: 
1) Participants with known dietary allergies will be excluded,  
2) Participants with known intolerances to ingredients of the study product, i.e. dairy, 
cow’s milk allergies, lactose intolerance, will be excluded,  
3) Participants with distress/fears/negative experience or unsure/uncertain on the 
associated requirements for blood samples and use of needles and/or cannulas, will be 
excluded, and  

23 
 
4) Participants injured/unbale to complete exercise testing will be excluded.  
 
Possible risks associated with this study include: 
• 
Exercise testing – possible risks include localised muscle soreness/damage/swelling, 
moderate fatigue, tiredness, dehydration, dizziness,  
 
• 
Blood collection - possible risks include: dizziness/fainting/ nausea, localised 
bruising/swelling and contamination/infection. Samples will only be collected by qualified 
researchers who are highly experienced in taking blood samples. Only in-date, sterilised, 
equipment will be used. 
 
• 
Nutrition products - with any nutrition product the following risks are possible albeit 
unlikely: contamination of products, acute side effects (nausea, dizziness, bloating 
and/or gastrointestinal distress from consumption) or allergic or adverse reaction to 
product. Products will only be sourced from a world leading nutrition company for safe 
public consumption. Should you experience any adverse reactions to either food product 
please advise the principal investigator immediately (Dr Ash Willmott). 
 
• 
Food diary collation/ and general data – there is the risk of ‘disclosure of personal 
information’; however, this is very unlikely as confidentiality will be maintained for all 
participants throughout the study using number coding instead of personal details. All 
data associated with this study will be password protected and fully anonymised for 
confidentiality. 
 
 
21. 
What are the likely benefits of taking part?   
 
Whilst this type of research will be used to support/design future studies on recovery strategies 
and the product’s efficacy, we will be providing you with information pertinent to your dietary 
analysis, which you might find useful to your day-to-day lifestyle, and your exercise testing data, 
which you might find useful for your own training interest. Once all the data has been compiled, 
we will share your individual data with you which will let you know more about how you 
responded to the nutritional drinks.  
 
22. 
Can I withdraw at any time, and how do I do this?   
 
You can withdraw from the study at any time and without giving a reason. Should you decide to 
withdraw from the study during or following your participation for any reason, please contact the 
principle investigators via email - Dr Ash Willmott: ash.willmott@aru.ac.uk. 
 
23. 
What will happen to my data? 
 
Our general privacy notice explaining our use of your personal data for research purposes is 
available here: 
 
https://www.anglia.ac.uk/privacy-and-cookies/research-participants  
 
Please visit this link for information about how long we keep your data, how we keep your data 
secure, how you can exercise your rights over your data, and make a complaint over our use of 
your data. 
 
 

24 
 
24. 
Can I withdraw my data from the study? 
 
If you wish to withdraw from the research, please speak to the researcher or email them at 
ash.willmott@aru.ac.uk stating the title of the research or send them this withdrawal slip. You 
do not have to give a reason for why you would like to withdraw. Please let the researcher know 
whether or not you are happy for the data that has been collected up to this point to still be used.   
You are completely free to ask for any data to also be removed should you wish it to be, if the 
data is not anonymised. When data is anonymised, it means personal data relating to it has 
been permanently removed, so the researcher will not know which belongs to you. You do not 
have to answer any questionnaire or interview questions you do not wish to. 
 
25. 
Whether there are any special precautions you must take before, during or after taking 
part in the study 
 
As outlined above and explained at the pre-screening assessment, you will be required to 
consume the provided standardised meals across the duration of the study. Participants will be 
required to refrain from physical activity and alcohol consumption 24 hours before each study 
visit too. You will also need to overnight fast (10 hours), consuming only water (up to 500 mL) 
before arrival for testing and avoid the consumption of any stimulants or protein formulas which 
may conflict with the study parameters (e.g. caffeine, energy drinks or whey protein shakes). If 
your health status changes, or you start taking medication, or other supplements during the time 
of the study, please let us know asap.   
 
Two servings of either the test or control product will be consumed after exercise on the following 
days - acute muscle fatigue exercise protocol day, two consecutive recovery days following 
acute muscle fatigue exercise protocol. The first serving will be consumed immediately after 
exercise and the second serving will be consumed in the afternoon between two meals (~2.5 
hours apart from each meal). Intake of the servings on subsequent recovery days will be at the 
same times as on the exercise day. 
 
26. 
Will I pass onto anyone else what you have told me? 
 
Your data will not be passed on to anybody internal or external that is not listed above. The only 
people who will be able to access the data, will be the principal investigator (Dr Ash Willmott) 
and members of the immediate research team, Addenbrookes Hospital Core Biochemical Assay 
Laboratory (for blood analysis) and Danone Global Research & Innovation Center, in the 
Netherlands. All data will be stored on a password protected hard drive. 
 
27. 
Summary of research findings 
 
A summary of the research findings will be available and can be provided to you, if you wish, 
following the completion of the study. This can be arranged after the completion of the study. 
The summary of research findings can be sent to you via email if you would like to provide these 
contact details. 
 
28. 
Contact details for complaints 
 
If you have any complaints about the study, please contact ash.willmott@aru.ac.uk in the first 
instance. There are also, however, details about ARU’s complaints procedure should you wish 
to use it. Email address: complaints@aru.ac.uk. Postal address: Office of the Secretary and 
Clerk, Anglia Ruskin University, Bishop Hall Lane, Chelmsford, Essex, CM1 1SQ. 
 
Version control = Date 01.5.25 V4 
 
 

25 
 
PARTICIPANT CONSENT FORM 
 
 
 
 
Th 
 
NAME OF PARTICIPANT: 
 
Title of the project: BOLT STUDY Part B: The effects of commercially available high protein 
drink on recovery from muscle fatiguing exercise in 18-45-year-old male and female 
participants 
 
Main investigator and contact details: Dr Ash Willmott (ash.willmott@aru.ac.uk)  
 
Members of the research team: Dr Sanjoy Deb, Mr Dirk Dugdale,  
 
1. 
I agree to take part in the above research. I have read the Participant Information Sheet 
(Date 01.5.25 V4) for the study. I understand what my role will be in this research, and 
all my questions have been answered to my satisfaction. 
 
2. 
I understand that I am free to withdraw from the research at any time, without giving a 
reason. To do this I understand I can use the withdrawal slip below or email the main 
investigator. 
 
3. 
I understand I am free to ask any questions at any time before and during the study. 
 
4.  
I understand what information will be collected from me for the study  
 
5. 
I understand what will happen to the data collected from me for the research. All blood 
samples will be collected, analysed and disposed of in accordance with the Human 
Tissue Act. 
 
6.  
For the purposes of the General Data Protection Regulation (2018), if this project 
requires me to produce personal data, I have read and understood how Anglia Ruskin 
University will process it. 
 
7.  
I have been told about any disadvantages or risks regarding me taking part.  
 
8.   
I have been informed how my data will be processed, how long it will be kept and when 
it will destroyed.  
 
9.  
I have been provided with a copy of this form and the Participant Information Sheet (Date 
01.5.25 V4) 
 
 
Name of participant (print)………………………… 
 
Signed………………..…. 
 
Date……………… 
 
 
 
 
 
 
 
 

26 
 
I WISH TO WITHDRAW FROM THIS STUDY. 
 
Title of the project: BOLT STUDY Part B: The effects of commercially available high protein 
drink on recovery from muscle fatiguing exercise in 18-45-year-old male and female 
participants. 
 
If you wish to withdraw from the research, please speak to the researcher or email 
them Dr Ash Willmott - ash.willmott@aru.ac.uk, stating the title of the research or send 
them this withdrawal slip. 
  
You do not have to give a reason for why you would like to withdraw. 
 
Date 01.5.25 V4