NCT04876495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

2.6 years

First QC Date

April 28, 2021

Last Update Submit

May 2, 2021

Conditions

Appetite and General Nutritional Disorders

Keywords

nutraceuticalproteinwheypotato proteinrice proteinappetitesatietyinsulinglucoseappetite hormoneGLP-1PYYsupplement

Outcome Measures

Primary Outcomes (32)

  • 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 Outcomes (1)

  • To assess the perception of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO®

    VAS for Palatability collected immediately after protein shake consumption

Study Arms (3)

Whey protein

ACTIVE COMPARATOR

Whey protein isolate (45.5g total protein content)

Dietary Supplement: Whey protein isolate

Potato protein

ACTIVE COMPARATOR

Potato protein isolate (45.3g total protein content)

Dietary Supplement: Potato protein isolate

Rice protein

ACTIVE COMPARATOR

Rice protein isolate (45.5g total protein content)

Dietary Supplement: Rice protein isolate

Interventions

Whey protein isolateDIETARY_SUPPLEMENT

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.

Whey protein
Potato protein isolateDIETARY_SUPPLEMENT

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.

Potato protein
Rice protein isolateDIETARY_SUPPLEMENT

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.

Rice protein

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipants' eligibility is based on self-representation of gender identity
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Westminster

London, Greater London, W1W 6UW, United Kingdom

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional 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
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: single-blind, randomised, triple crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Translational Physiology

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 6, 2021

Study Start

July 20, 2018

Primary Completion

February 19, 2021

Study Completion

February 19, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)