The Effects of Whey, Rice and Potato pRotein isOlates on appeTite rEgulatIoN in Healthy Men (PROTEIN)

Comparative Effects of Dairy and Plant-based Protein Intake on Acute Glucose Homeostasis and Appetite Regulation in Healthy Men

INTRODUCTION: Global protein consumption has been increasing for decades due to changes in socio-economic demographics and consumer trends towards higher protein intake, which may be related to their health benefits in performance nutrition and appetite regulation. The additional intake of protein often occurs in the form of supplements. One of the main ingredients used in sports and weight loss supplements are animal-derived proteins such as whey, which are of high quality, containing all the essential amino acids required in human nutrition with a high absorption rate. However, whey protein has a high environmental footprint, and it may contribute to insulin resistance in susceptible groups (e.g. obese, T2DM, insulin resistant, or those with sarcopenic obesity).

Rice and potato protein isolates are high-quality plant proteins containing all essential amino acids comparably to whey protein. These plant-derived proteins may provide a more sustainable and accessible alternative to animal-derived proteins for appetite regulation and weight management.

Study Overview

• Status: Completed
• Conditions: Appetite and General Nutritional Disorders
• Intervention / Treatment: Dietary supplement: Whey protein isolate; Dietary supplement: Potato protein isolate; Dietary supplement: Rice protein isolate

Detailed Description

Intervention study with three treatment groups in a randomised, single-blind, triple crossover design.

Study population: Healthy male participants will receive three different isocaloric and -volumetric protein shakes prepared using whey, rice and potato protein powders on different trial days with at least a one-week washout period apart.

Biological samples (blood and saliva samples) are collected at various time points during the visit. Blood samples are collected at baseline 10 min prior (T-10), then at 30 min (T30), 60 min (T60), 120 min (T120) and at 180 min (T180) after protein shake consumption. Saliva samples are collected at baseline (T-10), then at every 30 minutes following protein shake consumption (T30, T60, T90, T120, T150, T180). In addition, pertinent questionnaires Visual Analogue Scale [VAS] for the assessment of satiety and VAS for the assessment of protein shakes' perception will be collected at T-10, T30, T60, T90, T120, T150, T180 and at T0, respectively

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, W1W 6UW
      • University of Westminster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Males (18-65 years of age)
• Healthy subjects

Exclusion Criteria:

• <18 years or >65 years
• Consumption of >21 units of alcohol/week
• Dieters
• Any allergies/health issues related to items being ingested
• Any serious illnesses or those on medication
• Any illness affecting taste or appetite
• Any gastrointestinal disorders
• Any eating disorders
• Any depression/mental disorders
• Smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Whey protein; Whey protein isolate (45.5g total protein content)	Dietary supplement: Whey protein isolate; Instantized BiPRO® 50g (equiv. 45.5g of total protein) presented to participants in a form of a shake. Other ingredients in the whey protein shake: Tropicana Trop50 Orange Juice 207mL; Water 43 mL; Sucralose 0.5g The total energy 233.47Kcal. Participants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study.
Active Comparator: Potato protein; Potato protein isolate (45.3g total protein content)	Dietary supplement: Potato protein isolate; Solanic®100 48g (equiv. 45.3g of total protein) presented to participants in a form of a shake. Other ingredients in the potato protein shake: Tropicana Trop50 Orange Juice 250mL; Sucralose 0.5g The total energy 233.46Kcal Participants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study.
Active Comparator: Rice protein; Rice protein isolate (45.5g total protein content)	Dietary supplement: Rice protein isolate; Oryzatein® Silk 90 50g (equiv. 45.5g of total protein) presented to participants in a form of a shake. Other ingredients in the rice protein shake: Tropicana Trop50 Orange Juice 183mL; Water 67mL; Sucralose 0.5g The total energy 233.43Kcal Participants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T-10)	Marker: glucose (mmol/L)	Glucose measured 10 minutes prior to protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T30)	Marker: glucose (mmol/L)	Glucose measured 30 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T60)	Marker: glucose (mmol/L)	Glucose measured 60 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T120)	Marker: glucose (mmol/L)	Glucose measured 120 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T180)	Marker: glucose (mmol/L)	Glucose measured 180 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T-10)	Marker: insulin (ng/mL)	Insulin measured 10 minutes prior to protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T30)	Marker: insulin (ng/mL)	Insulin measured 30 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T60)	Marker: insulin (ng/mL)	Insulin measured 60 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T120)	Marker: insulin (ng/mL)	Insulin measured 120 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T180)	Marker: insulin (ng/mL)	Insulin measured 180 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T-10)	Markers: glucagon-like peptide 1 (pM)	Glucagon-like peptide 1 measured 10 minutes prior to protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T30)	Markers: glucagon-like peptide 1 (pM)	Glucagon-like peptide 1 measured 30 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T60)	Markers: glucagon-like peptide 1 (pM)	Glucagon-like peptide 1 measured 60 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T120)	Markers: glucagon-like peptide 1 (pM)	Glucagon-like peptide 1 measured 120 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T180)	Markers: glucagon-like peptide 1 (pM)	Glucagon-like peptide 1 measured 180 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T-10)	Markers: peptide tyrosine tyrosine (pg/mL)	Peptide tyrosine tyrosine measured 10 minutes prior to protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T30)	Markers: peptide tyrosine tyrosine (pg/mL)	Peptide tyrosine tyrosine measured 30 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T60)	Markers: peptide tyrosine tyrosine (pg/mL)	Peptide tyrosine tyrosine measured 60 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T120)	Markers: peptide tyrosine tyrosine (pg/mL)	Peptide tyrosine tyrosine measured 120 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T180)	Markers: peptide tyrosine tyrosine (pg/mL)	Peptide tyrosine tyrosine measured 180 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T-10)	Markers: ghrelin (pg/mL)	Ghrelin (pg/mL) measured 10 minutes prior to protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T30)	Markers: ghrelin (pg/mL)	Ghrelin (pg/mL) measured 30 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T60)	Markers: ghrelin (pg/mL)	Ghrelin (pg/mL) measured 60 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T120)	Markers: ghrelin (pg/mL)	Ghrelin (pg/mL) measured 120 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T180)	Markers: ghrelin (pg/mL)	Ghrelin (pg/mL) measured 180 minutes post protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T-10)	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 immediately prior to protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® 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 protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® 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 protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T90)	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 90 minutes after protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® 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 protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T150)	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 150 minutes after protein shake consumption
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® 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 protein shake consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the perception of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO®	Subjective analysis including: Visual Analogue Scale for Palatability (VAS-P). Scores range from 0 to 100 (the higher the score the lower the palatability)	VAS for Palatability collected immediately after protein shake consumption

Collaborators and Investigators

• Sponsor: University of Westminster
• Collaborators: Coventry University
• Investigators: Principal Investigator: Mohammed Gulrez Zariwala, PhD, University of Westminster

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): February 19, 2021
• Study Completion (Actual): February 19, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 2, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: GLP-1; appetite; insulin; supplement; satiety; glucose; protein; PYY; nutraceutical; whey; potato protein; rice protein; appetite hormone
• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: VRE1516-1375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No