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

Primary Purpose

Appetite and General Nutritional Disorders

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Whey protein isolate
Potato protein isolate
Rice protein isolate
Sponsored by
University of Westminster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Appetite and General Nutritional Disorders focused on measuring nutraceutical, protein, whey, potato protein, rice protein, appetite, satiety, insulin, glucose, appetite hormone, GLP-1, PYY, supplement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Westminster

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Whey protein

Potato protein

Rice protein

Arm Description

Whey protein isolate (45.5g total protein content)

Potato protein isolate (45.3g total protein content)

Rice protein isolate (45.5g total protein content)

Outcomes

Primary Outcome Measures

To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T-10)
Marker: glucose (mmol/L)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T30)
Marker: glucose (mmol/L)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T60)
Marker: glucose (mmol/L)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T120)
Marker: glucose (mmol/L)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T180)
Marker: glucose (mmol/L)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T-10)
Marker: insulin (ng/mL)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T30)
Marker: insulin (ng/mL)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T60)
Marker: insulin (ng/mL)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T120)
Marker: insulin (ng/mL)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T180)
Marker: insulin (ng/mL)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T-10)
Markers: ghrelin (pg/mL)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T30)
Markers: ghrelin (pg/mL)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T60)
Markers: ghrelin (pg/mL)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T120)
Markers: ghrelin (pg/mL)
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T180)
Markers: ghrelin (pg/mL)
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)
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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

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)

Full Information

First Posted
April 28, 2021
Last Updated
May 2, 2021
Sponsor
University of Westminster
Collaborators
Coventry University
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1. Study Identification

Unique Protocol Identification Number
NCT04876495
Brief Title
The Effects of Whey, Rice and Potato pRotein isOlates on appeTite rEgulatIoN in Healthy Men
Acronym
PROTEIN
Official Title
Comparative Effects of Dairy and Plant-based Protein Intake on Acute Glucose Homeostasis and Appetite Regulation in Healthy Men
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Westminster
Collaborators
Coventry University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite and General Nutritional Disorders
Keywords
nutraceutical, protein, whey, potato protein, rice protein, appetite, satiety, insulin, glucose, appetite hormone, GLP-1, PYY, supplement

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
single-blind, randomised, triple crossover
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey protein
Arm Type
Active Comparator
Arm Description
Whey protein isolate (45.5g total protein content)
Arm Title
Potato protein
Arm Type
Active Comparator
Arm Description
Potato protein isolate (45.3g total protein content)
Arm Title
Rice protein
Arm Type
Active Comparator
Arm Description
Rice protein isolate (45.5g total protein content)
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein isolate
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Potato protein isolate
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Rice protein isolate
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T-10)
Description
Marker: glucose (mmol/L)
Time Frame
Glucose measured 10 minutes prior to protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T30)
Description
Marker: glucose (mmol/L)
Time Frame
Glucose measured 30 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T60)
Description
Marker: glucose (mmol/L)
Time Frame
Glucose measured 60 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T120)
Description
Marker: glucose (mmol/L)
Time Frame
Glucose measured 120 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T180)
Description
Marker: glucose (mmol/L)
Time Frame
Glucose measured 180 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T-10)
Description
Marker: insulin (ng/mL)
Time Frame
Insulin measured 10 minutes prior to protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T30)
Description
Marker: insulin (ng/mL)
Time Frame
Insulin measured 30 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T60)
Description
Marker: insulin (ng/mL)
Time Frame
Insulin measured 60 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T120)
Description
Marker: insulin (ng/mL)
Time Frame
Insulin measured 120 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T180)
Description
Marker: insulin (ng/mL)
Time Frame
Insulin measured 180 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T-10)
Description
Markers: glucagon-like peptide 1 (pM)
Time Frame
Glucagon-like peptide 1 measured 10 minutes prior to protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T30)
Description
Markers: glucagon-like peptide 1 (pM)
Time Frame
Glucagon-like peptide 1 measured 30 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T60)
Description
Markers: glucagon-like peptide 1 (pM)
Time Frame
Glucagon-like peptide 1 measured 60 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T120)
Description
Markers: glucagon-like peptide 1 (pM)
Time Frame
Glucagon-like peptide 1 measured 120 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T180)
Description
Markers: glucagon-like peptide 1 (pM)
Time Frame
Glucagon-like peptide 1 measured 180 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T-10)
Description
Markers: peptide tyrosine tyrosine (pg/mL)
Time Frame
Peptide tyrosine tyrosine measured 10 minutes prior to protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T30)
Description
Markers: peptide tyrosine tyrosine (pg/mL)
Time Frame
Peptide tyrosine tyrosine measured 30 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T60)
Description
Markers: peptide tyrosine tyrosine (pg/mL)
Time Frame
Peptide tyrosine tyrosine measured 60 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T120)
Description
Markers: peptide tyrosine tyrosine (pg/mL)
Time Frame
Peptide tyrosine tyrosine measured 120 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T180)
Description
Markers: peptide tyrosine tyrosine (pg/mL)
Time Frame
Peptide tyrosine tyrosine measured 180 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T-10)
Description
Markers: ghrelin (pg/mL)
Time Frame
Ghrelin (pg/mL) measured 10 minutes prior to protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T30)
Description
Markers: ghrelin (pg/mL)
Time Frame
Ghrelin (pg/mL) measured 30 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T60)
Description
Markers: ghrelin (pg/mL)
Time Frame
Ghrelin (pg/mL) measured 60 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T120)
Description
Markers: ghrelin (pg/mL)
Time Frame
Ghrelin (pg/mL) measured 120 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T180)
Description
Markers: ghrelin (pg/mL)
Time Frame
Ghrelin (pg/mL) measured 180 minutes post protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T-10)
Description
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)
Time Frame
Visual Analogue Scale for Appetite (VAS-A) collected immediately prior to protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T30)
Description
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)
Time Frame
Visual Analogue Scale for Appetite (VAS-A) collected 30 minutes after protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T60)
Description
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)
Time Frame
Visual Analogue Scale for Appetite (VAS-A) collected 60 minutes after protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T90)
Description
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)
Time Frame
Visual Analogue Scale for Appetite (VAS-A) collected 90 minutes after protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T120)
Description
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)
Time Frame
Visual Analogue Scale for Appetite (VAS-A) collected 120 minutes after protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T150)
Description
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)
Time Frame
Visual Analogue Scale for Appetite (VAS-A) collected 150 minutes after protein shake consumption
Title
To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T180)
Description
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)
Time Frame
Visual Analogue Scale for Appetite (VAS-A) collected 180 minutes after protein shake consumption
Secondary Outcome Measure Information:
Title
To assess the perception of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO®
Description
Subjective analysis including: Visual Analogue Scale for Palatability (VAS-P). Scores range from 0 to 100 (the higher the score the lower the palatability)
Time Frame
VAS for Palatability collected immediately after protein shake consumption

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participants' eligibility is based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Gulrez Zariwala, PhD
Organizational Affiliation
University of Westminster
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Westminster
City
London
State/Province
Greater London
ZIP/Postal Code
W1W 6UW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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