Clinical trial NCT04876495: The Effects of Whey, Rice and Potato pRotein isOlates on appeTite rEgulatIoN in Healthy Men
Official title: Comparative Effects of Dairy and Plant-based Protein Intake on Acute Glucose Homeostasis and Appetite Regulation in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite and General Nutritional Disorders
Keywords: nutraceutical
protein
whey
potato protein
rice protein
appetite
satiety
insulin
glucose
appetite hormone
GLP-1
PYY
supplement
Lead sponsor: University of Westminster
Sponsor class: OTHER
Collaborators: name: Coventry University
First posted: 2021-05-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: single-blind, randomised, triple crossover
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T-10)
timeFrame: Glucose measured 10 minutes prior to protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T30)
timeFrame: Glucose measured 30 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T60)
timeFrame: Glucose measured 60 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T120)
timeFrame: Glucose measured 120 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T180)
timeFrame: Glucose measured 180 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T-10)
timeFrame: Insulin measured 10 minutes prior to protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T30)
timeFrame: Insulin measured 30 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T60)
timeFrame: Insulin measured 60 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T120)
timeFrame: Insulin measured 120 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T180)
timeFrame: Insulin measured 180 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T-10)
timeFrame: Glucagon-like peptide 1 measured 10 minutes prior to protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T30)
timeFrame: Glucagon-like peptide 1 measured 30 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T60)
timeFrame: Glucagon-like peptide 1 measured 60 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T120)
timeFrame: Glucagon-like peptide 1 measured 120 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T180)
timeFrame: Glucagon-like peptide 1 measured 180 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T-10)
timeFrame: Peptide tyrosine tyrosine measured 10 minutes prior to protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T30)
timeFrame: Peptide tyrosine tyrosine measured 30 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T60)
timeFrame: Peptide tyrosine tyrosine measured 60 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T120)
timeFrame: Peptide tyrosine tyrosine measured 120 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T180)
timeFrame: Peptide tyrosine tyrosine measured 180 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T-10)
timeFrame: Ghrelin (pg/mL) measured 10 minutes prior to protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T30)
timeFrame: Ghrelin (pg/mL) measured 30 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T60)
timeFrame: Ghrelin (pg/mL) measured 60 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T120)
timeFrame: Ghrelin (pg/mL) measured 120 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T180)
timeFrame: Ghrelin (pg/mL) measured 180 minutes post protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T-10)
timeFrame: Visual Analogue Scale for Appetite (VAS-A) collected immediately prior to protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T30)
timeFrame: Visual Analogue Scale for Appetite (VAS-A) collected 30 minutes after protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T60)
timeFrame: Visual Analogue Scale for Appetite (VAS-A) collected 60 minutes after protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T90)
timeFrame: Visual Analogue Scale for Appetite (VAS-A) collected 90 minutes after protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T120)
timeFrame: Visual Analogue Scale for Appetite (VAS-A) collected 120 minutes after protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T150)
timeFrame: Visual Analogue Scale for Appetite (VAS-A) collected 150 minutes after protein shake consumption
measure: To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T180)
timeFrame: Visual Analogue Scale for Appetite (VAS-A) collected 180 minutes after protein shake consumption
Secondary outcomes:
measure: To assess the perception of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO®
timeFrame: VAS for Palatability collected immediately after protein shake consumption
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University of Westminster
state: Greater London
Study officials:
affiliation: University of Westminster
name: Mohammed Gulrez Zariwala, PhD
role: PRINCIPAL_INVESTIGATOR
References: