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

NCT07104461 | Completed

• 1 other identifier: ETH2223-1377
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Appetite and General Nutritional Disorders

Keywords

nutraceutical; protein; whey; potato protein; rice protein; pea protein; appetite; satiety; insulin; glucose; ghrelin; appetite hormone; GLP-1; PYY; GIP; supplement

Outcome Measures

Primary Outcomes (28)

• 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)

  Glucose measured 30 minutes post meal consumption

• 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)

  Glucose measured 60 minutes post meal consumption

• 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)

  Glucose measured 120 minutes post meal consumption

• 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)

  Glucose measured 180 minutes post meal consumption

• 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)

  Insulin measured 30 minutes post meal consumption

• 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)

  Insulin measured 160 minutes post meal consumption

• 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)

  Insulin measured 120 minutes post meal consumption

• 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)

  Insulin measured 180 minutes post meal consumption

• 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)

  Glucagon-like peptide 1 measured 30 minutes post meal consumption

• 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)

  Glucagon-like peptide 1 measured 60 minutes post meal consumption

• 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)

  Glucagon-like peptide 1 measured 120 minutes post meal consumption

• 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)

  Glucagon-like peptide 1 measured 180 minutes post meal consumption

• 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)

  Gastric inhibitory polypeptide measured 30 minutes post meal consumption

• 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)

  Gastric inhibitory polypeptide measured 60 minutes post meal consumption

• 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)

  Gastric inhibitory polypeptide measured 120 minutes post meal consumption

• 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)

  Gastric inhibitory polypeptide measured 180 minutes post meal consumption

• 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)

  Peptide tyrosine tyrosine measured 30 minutes post meal consumption

• 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)

  Peptide tyrosine tyrosine measured 60 minutes post meal consumption

• 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)

  Peptide tyrosine tyrosine measured 120 minutes post meal consumption

• 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)

  Peptide tyrosine tyrosine measured 180 minutes post meal consumption

• 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)

  Ghrelin measured 30 minutes post meal consumption

• 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)

  Ghrelin measured 60 minutes post meal consumption

• 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)

  Ghrelin measured 120 minutes post meal consumption

• 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)

  Ghrelin measured 180 minutes post meal consumption

• 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)

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

• 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)

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

• 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)

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

• 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)

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

Secondary Outcomes (2)

• 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).

  VAS for Perception and Palatability collected immediately after meal consumption

• 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.

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

Study Arms (4)

Oat porridge

SHAM COMPARATOR

Control Meal (9.5 g total protein)

Other: Oat porridge

Oat porridge with whey protein

ACTIVE COMPARATOR

(total protein 40.5 g; of which whey protein isolate contributed 34.2 g of protein)

Dietary Supplement: Whey protein isolate

Oat porridge with potato protein

ACTIVE COMPARATOR

(total protein 40.6 g; of which potato protein isolate contributed 34.39 g of protein)

Dietary Supplement: Potato protein isolate

Meal replacement shake

ACTIVE COMPARATOR

(total protein 40 g, mostly from pea protein and brown rice protein isolates)

Dietary Supplement: Meal replacement shake

Interventions

Oat porridge OTHER

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.

Oat porridge

Whey protein isolate DIETARY_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

Oat porridge with whey protein

Potato protein isolate DIETARY_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.

Oat porridge with potato protein

Meal replacement shake DIETARY_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.

Meal replacement shake

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)
• Devices such as pacemakers
• Smokers
• Gastrointestinal disorders
• Eating disorders

Sponsors & Collaborators

• University of Westminster: lead

Study Sites (1)

Centre for Nutraceuticals School of Life Sciences, University of Westminster

London, W1W 6UW, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 32175717 BACKGROUND

• 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.

  PMID: 39605914 BACKGROUND

• 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.

  PMID: 32292920 BACKGROUND

• 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.

  PMID: 28244632 BACKGROUND

• 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.

  PMID: 26884639 BACKGROUND

• 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.

  PMID: 22510792 BACKGROUND

• 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.

  PMID: 39547251 BACKGROUND

Related Links

• NHS. (2023). Obesity - Treatment
• WHO. (2024). Obesity and overweight. World Health Organization.
• WHO. (2015). World health statistics 2015. World Health Organization

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohammed Gulrez Zariwala, PhD

  University of Westminster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Physiology

Model Details: Crossover Assignment, single-blind, randomised, quadruple crossover

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: June 9, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 21, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)