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OpenTrials
Completed

NCT Number: NCT04876495

The Effects of Whey, Rice and Potato pRotein isOlates on 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.

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Key information

Conditions

Appetite and General Nutritional Disorders Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Westminster

London, Greater London, W1W 6UW, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey protein isolate

Dietary 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.

Potato protein isolate

Dietary 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.

Rice protein isolate

Dietary 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.

Primary outcomes

  1. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T-10)

    Time frame: Glucose measured 10 minutes prior to protein shake consumption

    Marker: glucose (mmol/L)

  2. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T30)

    Time frame: Glucose measured 30 minutes post protein shake consumption

    Marker: glucose (mmol/L)

  3. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T60)

    Time frame: Glucose measured 60 minutes post protein shake consumption

    Marker: glucose (mmol/L)

  4. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T120)

    Time frame: Glucose measured 120 minutes post protein shake consumption

    Marker: glucose (mmol/L)

  5. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T180)

    Time frame: Glucose measured 180 minutes post protein shake consumption

    Marker: glucose (mmol/L)

  6. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T-10)

    Time frame: Insulin measured 10 minutes prior to protein shake consumption

    Marker: insulin (ng/mL)

  7. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T30)

    Time frame: Insulin measured 30 minutes post protein shake consumption

    Marker: insulin (ng/mL)

  8. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T60)

    Time frame: Insulin measured 60 minutes post protein shake consumption

    Marker: insulin (ng/mL)

  9. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T120)

    Time frame: Insulin measured 120 minutes post protein shake consumption

    Marker: insulin (ng/mL)

  10. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T180)

    Time frame: Insulin measured 180 minutes post protein shake consumption

    Marker: insulin (ng/mL)

  11. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T-10)

    Time frame: Glucagon-like peptide 1 measured 10 minutes prior to protein shake consumption

    Markers: glucagon-like peptide 1 (pM)

  12. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T30)

    Time frame: Glucagon-like peptide 1 measured 30 minutes post protein shake consumption

    Markers: glucagon-like peptide 1 (pM)

  13. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T60)

    Time frame: Glucagon-like peptide 1 measured 60 minutes post protein shake consumption

    Markers: glucagon-like peptide 1 (pM)

  14. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T120)

    Time frame: Glucagon-like peptide 1 measured 120 minutes post protein shake consumption

    Markers: glucagon-like peptide 1 (pM)

  15. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T180)

    Time frame: Glucagon-like peptide 1 measured 180 minutes post protein shake consumption

    Markers: glucagon-like peptide 1 (pM)

  16. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T-10)

    Time frame: Peptide tyrosine tyrosine measured 10 minutes prior to protein shake consumption

    Markers: peptide tyrosine tyrosine (pg/mL)

  17. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T30)

    Time frame: Peptide tyrosine tyrosine measured 30 minutes post protein shake consumption

    Markers: peptide tyrosine tyrosine (pg/mL)

  18. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T60)

    Time frame: Peptide tyrosine tyrosine measured 60 minutes post protein shake consumption

    Markers: peptide tyrosine tyrosine (pg/mL)

  19. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T120)

    Time frame: Peptide tyrosine tyrosine measured 120 minutes post protein shake consumption

    Markers: peptide tyrosine tyrosine (pg/mL)

  20. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T180)

    Time frame: Peptide tyrosine tyrosine measured 180 minutes post protein shake consumption

    Markers: peptide tyrosine tyrosine (pg/mL)

  21. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T-10)

    Time frame: Ghrelin (pg/mL) measured 10 minutes prior to protein shake consumption

    Markers: ghrelin (pg/mL)

  22. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T30)

    Time frame: Ghrelin (pg/mL) measured 30 minutes post protein shake consumption

    Markers: ghrelin (pg/mL)

  23. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T60)

    Time frame: Ghrelin (pg/mL) measured 60 minutes post protein shake consumption

    Markers: ghrelin (pg/mL)

  24. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T120)

    Time frame: Ghrelin (pg/mL) measured 120 minutes post protein shake consumption

    Markers: ghrelin (pg/mL)

  25. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T180)

    Time frame: Ghrelin (pg/mL) measured 180 minutes post protein shake consumption

    Markers: ghrelin (pg/mL)

  26. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T-10)

    Time frame: Visual Analogue Scale for Appetite (VAS-A) collected immediately prior to protein shake consumption

    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)

  27. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T30)

    Time frame: Visual Analogue Scale for Appetite (VAS-A) collected 30 minutes after protein shake consumption

    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)

  28. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T60)

    Time frame: Visual Analogue Scale for Appetite (VAS-A) collected 60 minutes after protein shake consumption

    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)

  29. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T90)

    Time frame: Visual Analogue Scale for Appetite (VAS-A) collected 90 minutes after protein shake consumption

    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)

  30. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T120)

    Time frame: Visual Analogue Scale for Appetite (VAS-A) collected 120 minutes after protein shake consumption

    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)

  31. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T150)

    Time frame: Visual Analogue Scale for Appetite (VAS-A) collected 150 minutes after protein shake consumption

    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)

  32. To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T180)

    Time frame: Visual Analogue Scale for Appetite (VAS-A) collected 180 minutes after protein shake consumption

    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 outcomes

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

    Time frame: VAS for Palatability collected immediately after protein shake consumption

    Subjective analysis including: Visual Analogue Scale for Palatability (VAS-P). Scores range from 0 to 100 (the higher the score the lower the palatability)

Sponsors and collaborators

Lead sponsor

University of Westminster

Other

Collaborators

  • Coventry University

Registry information

Official study title

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

Acronym: PROTEIN

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 6, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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