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Appetite and General Nutritional DisordersAPPETITENCT07104461

Advanced Protein-based Program for Effective Treatment of Appetite Regulation and Obesity

A study testing Oat porridge, Whey protein isolate and Potato protein isolate in people with Appetite and General Nutritional Disorders, run by University of Westminster at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

INTRODUCTION: Obesity is a global epidemic, with over 2.5 billion adults being classified as overweight and 890 million of these classified as obese. Overweight and obesity are the 5th cause of mortality globally, with an estimated 2.8 million related deaths among adults. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
What is being tested?
Oat porridge, Whey protein isolate and Potato protein isolate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
9 Jun 2023to 31 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males (18-50 years of age)
  • Lean and Overweight subjects (BMI 18.5 - 30 kg/m2)
  • Sedentary and physically active subjects
  • Healthy subjects

Who cannot join

  • Female
  • <18, >50 years
  • Dieting
  • Consumption of >14 units of alcohol/week
  • Allergies to test foods/drinks
  • Illnesses or on medication (with a possible effect on taste and/or appetite)
Show all 10Show fewer
  • Devices such as pacemakers
  • Smokers
  • Gastrointestinal disorders
  • Eating disorders

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Centre for Nutraceuticals School of Life Sciences, University of Westminster

    London, W1W 6UW

Other trials in United Kingdom

About this study

Official title: A Single-blind Randomised Study to Test the Effects of Protein-enriched Breakfast Meals With Varying Protein Sources Compared to a Standard Meal on the Regulation of Appetite and Satiety in Healthy Human Volunteers

INTRODUCTION: Obesity is a global epidemic, with over 2.5 billion adults being classified as overweight and 890 million of these classified as obese. Overweight and obesity are the 5th cause of mortality globally, with an estimated 2.8 million related deaths among adults. The rising prevalence of obesity in adults is leading to a rise in the prevalence of type 2 diabetes, with an estimated 462 million individuals affected globally. At present, the most effective non-surgical obesity treatments offered by the National Health Service (NHS) are the subcutaneously administered GLP-1 receptor agonists. However, they may present potentially serious side effects following short-term use, and there are still uncertainties around long-term use side effects. Therefore, a dietary approach to weight loss or maintenance seems preferable.

Increasing protein intake is a commonly applied nutritional approach to appetite regulation. The increase in protein intake is often achieved by supplementation, using proteins isolated from dairy, such as whey and casein. However, with more individuals following plant-based diets over recent years, the interest in plant-based protein supplements has increased. While dairy-based proteins are well-characterised, the appetite regulatory characteristics of plant-based proteins have not yet been fully elucidated.

The main aim of this study is to investigate the effects of protein-enriched food items on appetite regulation compared to a standard carbohydrate-rich meal. Furthermore, this study will investigate whether there are any differences in appetite-related hormonal responses to a plant protein-containing meal replacement shake (containing rice and pea protein) or a potato protein-enriched standard carbohydrate-based meal compared to a whey protein-enriched standard carbohydrate-based meal.

Read the detailed description

Intervention study with four treatment groups in a randomised, single-blind, quadruple crossover design.

Healthy male participants (between the ages of 18 to 50 years) will receive four different isocaloric intervention meals with the same mass, on separate visit days, following a minimum of 8 hours overnight fast. The four meals will contain oat porridge prepared with coconut milk as a control, oat porridge prepared with coconut milk with added whey or potato protein isolates, and a complete meal replacement shake containing plant-based pea and rice proteins. The intervention meals will be followed by a standardised pasta-based ready meal after the 3-hour observation period. All participants will observe at least a two-day washout period between the differing treatments.

Biological samples (blood) will be collected at various times during the visit. Blood samples will be collected at baseline 0 min prior (T0), then at 30 min (T30), 60 min (T60), 120 min (T120) and 180 min (T180) after the intervention meal consumption.

In addition, pertinent questionnaires, Visual Analogue Scale [VAS] for assessing satiety and VAS for assessing intervention meals' perception and palatability will be collected. VAS for the assessment of satiety will be collected at T0, T30, T60, T120 and T180 and VAS assessing the perception and palatability of the intervention meals will be collected immediately following meal consumption.

Being tested
Oat porridge, Whey protein isolate, Potato protein isolate, Meal replacement shake
Keywords
nutraceutical, protein, whey, potato protein, rice protein, pea protein, appetite, satiety, insulin, glucose, ghrelin, appetite hormone, GLP-1, PYY, GIP, supplement
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oat porridgeOther

    Oat flakes, 81g (equivalent to 9 g of protein), were presented to participants in the form of porridge, prepared with 500 mL coconut milk (equivalent to 0.5 g of protein) and 10 g of zero calorie sugar free syrup.

    The total energy content was equivalent to 400 Kcal.

    Participants were instructed to consume the entire meal presented to them in 15 minutes on an empty stomach when attending the study.

  • Whey protein isolateDietary supplement

    Whey protein isolate, 38g (equivalent to 34.2 g of protein), was presented to participants in the form of a porridge.

    Other ingredients in the whey protein enriched porridge:

    • Oat flakes 54 g (equivalent to 6 g of protein)
    • Coconut milk 300 mL (equivalent to 0.3 g of protein)
    • Water 150 mL
    • Zero calorie sugar free syrup 10 g

    The total energy content was equivalent to 401.74 Kcal.

    Participants were instructed to consume the entire meal presented to them in 15 minutes on an empty stomach when attending the study

  • Potato protein isolateDietary supplement

    Potato protein isolate, 38g (equivalent to 34.39 g of protein), was presented to participants in the form of a porridge.

    Other ingredients in the potato protein enriched porridge:

    • Oat flakes 54 g (equivalent to 6 g of protein)
    • Coconut milk 300 mL (equivalent to 0.3 g of protein)
    • Water 150 mL
    • Zero calorie sugar free syrup 10 g

    The total energy content equiv. 401.36 Kcal.

    Participants were instructed to consume the entire meal presented to them in 15 minutes on an empty stomach when attending the study.

  • Meal replacement shakeDietary supplement

    A meal replacement, 90 g (equivalent to 40 g of total protein), was presented to participants in the form of a shake.

    Other ingredients in the meal replacement shake:

    • Water 500 mL

    The total energy was equivalent to 400 Kcal

    Participants were instructed to consume the entire meal replacement shake presented to them in 15 minutes on an empty stomach when attending the study.

Study groups in NCT07104461
Study groupRoleWhat they receive
Oat porridgeSham comparatorControl Meal (9.5 g total protein)
Receives: Other: Oat porridge
Oat porridge with whey proteinActive comparator(total protein 40.5 g; of which whey protein isolate contributed 34.2 g of protein)
Receives: Dietary Supplement: Whey protein isolate
Oat porridge with potato proteinActive comparator(total protein 40.6 g; of which potato protein isolate contributed 34.39 g of protein)
Receives: Dietary Supplement: Potato protein isolate
Meal replacement shakeActive comparator(total protein 40 g, mostly from pea protein and brown rice protein isolates)
Receives: Dietary Supplement: Meal replacement shake

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate and meal replacement shake on glucose levels (T30)

    Glucose (mmol/L)

    Measured: Glucose measured 30 minutes post meal consumption

  2. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucose levels (T60)

    Glucose (mmol/L)

    Measured: Glucose measured 60 minutes post meal consumption

  3. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucose levels (T120)

    Glucose (mmol/L)

    Measured: Glucose measured 120 minutes post meal consumption

  4. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucose levels (T180)

    Glucose (mmol/L)

    Measured: Glucose measured 180 minutes post meal consumption

  5. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on insulin levels (T30)

    Insulin (pmol/L)

    Measured: Insulin measured 30 minutes post meal consumption

  6. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on insulin levels (T60)

    Insulin (pmol/L)

    Measured: Insulin measured 160 minutes post meal consumption

  7. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on insulin levels (T120)

    Insulin (pmol/L)

    Measured: Insulin measured 120 minutes post meal consumption

  8. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on insulin levels (T180)

    Insulin (pmol/L)

    Measured: Insulin measured 180 minutes post meal consumption

  9. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucagon-like peptide 1 levels (T30)

    Glucagon-like peptide 1 (pmol/L)

    Measured: Glucagon-like peptide 1 measured 30 minutes post meal consumption

  10. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucagon-like peptide 1 levels (T60)

    Glucagon-like peptide 1 (pmol/L)

    Measured: Glucagon-like peptide 1 measured 60 minutes post meal consumption

  11. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucagon-like peptide 1 levels (T120)

    Glucagon-like peptide 1 (pmol/L)

    Measured: Glucagon-like peptide 1 measured 120 minutes post meal consumption

  12. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucagon-like peptide 1 levels (T180)

    Glucagon-like peptide 1 (pmol/L)

    Measured: Glucagon-like peptide 1 measured 180 minutes post meal consumption

  13. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on gastric inhibitory polypeptide (T30)

    Glucagon-like peptide 1 (pmol/L)

    Measured: Gastric inhibitory polypeptide measured 30 minutes post meal consumption

  14. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on gastric inhibitory polypeptide (T60)

    Glucagon-like peptide 1 (pmol/L)

    Measured: Gastric inhibitory polypeptide measured 60 minutes post meal consumption

  15. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on gastric inhibitory polypeptide (T120)

    Glucagon-like peptide 1 (pmol/L)

    Measured: Gastric inhibitory polypeptide measured 120 minutes post meal consumption

  16. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on gastric inhibitory polypeptide (T180)

    Glucagon-like peptide 1 (pmol/L)

    Measured: Gastric inhibitory polypeptide measured 180 minutes post meal consumption

  17. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on peptide tyrosine tyrosine levels (T30)

    Peptide tyrosine tyrosine (pmol/L)

    Measured: Peptide tyrosine tyrosine measured 30 minutes post meal consumption

  18. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on peptide tyrosine tyrosine levels (T60) Markers: peptide tyrosine tyrosine (pmol/L)

    Peptide tyrosine tyrosine (pmol/L)

    Measured: Peptide tyrosine tyrosine measured 60 minutes post meal consumption

  19. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on peptide tyrosine tyrosine levels (T120)

    Peptide tyrosine tyrosine (pmol/L)

    Measured: Peptide tyrosine tyrosine measured 120 minutes post meal consumption

  20. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on peptide tyrosine tyrosine levels (T180)

    Peptide tyrosine tyrosine (pmol/L)

    Measured: Peptide tyrosine tyrosine measured 180 minutes post meal consumption

  21. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on ghrelin levels (T30)

    Ghrelin (pmol/L)

    Measured: Ghrelin measured 30 minutes post meal consumption

  22. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on ghrelin levels (T60)

    Ghrelin (pmol/L)

    Measured: Ghrelin measured 60 minutes post meal consumption

  23. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on ghrelin levels (T120)

    Ghrelin (pmol/L)

    Measured: Ghrelin measured 120 minutes post meal consumption

  24. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on ghrelin levels (T180)

    Ghrelin (pmol/L)

    Measured: Ghrelin measured 180 minutes post meal consumption

  25. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on appetite (T30)

    Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score, the greater the level of appetite)

    Measured: Visual Analogue Scale for Appetite (VAS-A) collected 30 minutes after meal consumption

  26. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on appetite (T60)

    Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score, the greater the level of appetite)

    Measured: Visual Analogue Scale for Appetite (VAS-A) collected 60 minutes after meal consumption

  27. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on appetite (T120)

    Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score, the greater the level of appetite)

    Measured: Visual Analogue Scale for Appetite (VAS-A) collected 120 minutes after meal consumption

  28. To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on appetite (T180)

    Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score, the greater the level of appetite)

    Measured: Visual Analogue Scale for Appetite (VAS-A) collected 180 minutes after meal consumption

Secondary outcomes (2)
  1. To assess the perception of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake. Subjective analysis including Visual Analogue Scale for Perception and Palatability (VAS-P).

    Scores range from 0 to 100 (the higher the score, the lower the palatability)

    Measured: VAS for Perception and Palatability collected immediately after meal consumption

  2. To assess the effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on food intake ad libitum, 3 hours after the intervention meal consumption.

    Consecutive meal intake was assessed by measuring the weight in grams and calculating the energy content in Kcal of the food consumed.

    Measured: Ad libitum food intake was assessed 3 hours post breakfast intervention meal consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start9 Jun 2023
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Crossover Assignment, single-blind, randomised, quadruple crossover
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07104461
Sponsor's protocol ID
ETH2223-1377
Acronym
APPETITE
Status last verified
Jul 2025
First submitted
29 Jul 2025
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.

    PubMed 32175717
  • Guo H, Guo Q, Li Z, Wang Z. Association between different GLP-1 receptor agonists and acute pancreatitis: case series and real-world pharmacovigilance analysis. Front Pharmacol. 2024 Nov 13;15:1461398. doi: 10.3389/fphar.2024.1461398. eCollection 2024.

    PubMed 39605914
  • Ismail I, Hwang YH, Joo ST. Meat analog as future food: a review. J Anim Sci Technol. 2020 Mar;62(2):111-120. doi: 10.5187/jast.2020.62.2.111. Epub 2020 Mar 31.

    PubMed 32292920
  • Monami M, Nreu B, Scatena A, Cresci B, Andreozzi F, Sesti G, Mannucci E. Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): Data from randomized controlled trials. Diabetes Obes Metab. 2017 Sep;19(9):1233-1241. doi: 10.1111/dom.12926. Epub 2017 Jun 20.

    PubMed 28244632
  • Patel S. Emerging trends in nutraceutical applications of whey protein and its derivatives. J Food Sci Technol. 2015 Nov;52(11):6847-58. doi: 10.1007/s13197-015-1894-0. Epub 2015 Jun 9.

    PubMed 26884639
  • Santesso N, Akl EA, Bianchi M, Mente A, Mustafa R, Heels-Ansdell D, Schunemann HJ. Effects of higher- versus lower-protein diets on health outcomes: a systematic review and meta-analysis. Eur J Clin Nutr. 2012 Jul;66(7):780-8. doi: 10.1038/ejcn.2012.37. Epub 2012 Apr 18.

    PubMed 22510792
  • Zushin PH, Wu JC. Evaluating the benefits of the early use of GLP-1 receptor agonists. Lancet. 2025 Jan 18;405(10474):181-183. doi: 10.1016/S0140-6736(24)02255-4. Epub 2024 Nov 12. No abstract available.

    PubMed 39547251

Questions about this trial

What is this clinical trial studying?

A study testing Oat porridge, Whey protein isolate and Potato protein isolate in people with Appetite and General Nutritional Disorders, run by University of Westminster at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate and meal replacement shake on glucose levels (T30) (time frame: Glucose measured 30 minutes post meal consumption). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07104461, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

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