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Appetite and General Nutritional DisordersPROTEINNCT04876495

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

A study testing Whey protein isolate, Potato protein isolate and Rice protein isolate in people with Appetite and General Nutritional Disorders, run by University of Westminster at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
What is being tested?
Whey protein isolate, Potato protein isolate and Rice protein isolate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
20 Jul 2018to 19 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • <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
Show all 10Show fewer
  • Any gastrointestinal disorders
  • Any eating disorders
  • Any depression/mental disorders
  • Smoking

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Westminster

    London, Greater London, W1W 6UW

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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

Being tested
Whey protein isolate, Potato protein isolate, Rice protein isolate
Keywords
nutraceutical, protein, whey, potato protein, rice protein, appetite, satiety, insulin, glucose, appetite hormone, GLP-1, PYY, supplement
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

Study groups in NCT04876495
Study groupRoleWhat they receive
Whey proteinActive comparatorWhey protein isolate (45.5g total protein content)
Receives: Dietary Supplement: Whey protein isolate
Potato proteinActive comparatorPotato protein isolate (45.3g total protein content)
Receives: Dietary Supplement: Potato protein isolate
Rice proteinActive comparatorRice protein isolate (45.5g total protein content)
Receives: Dietary Supplement: Rice protein isolate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Marker: glucose (mmol/L)

    Measured: Glucose measured 10 minutes prior to protein shake consumption

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

    Marker: glucose (mmol/L)

    Measured: Glucose measured 30 minutes post protein shake consumption

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

    Marker: glucose (mmol/L)

    Measured: Glucose measured 60 minutes post protein shake consumption

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

    Marker: glucose (mmol/L)

    Measured: Glucose measured 120 minutes post protein shake consumption

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

    Marker: glucose (mmol/L)

    Measured: Glucose measured 180 minutes post protein shake consumption

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

    Marker: insulin (ng/mL)

    Measured: Insulin measured 10 minutes prior to protein shake consumption

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

    Marker: insulin (ng/mL)

    Measured: Insulin measured 30 minutes post protein shake consumption

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

    Marker: insulin (ng/mL)

    Measured: Insulin measured 60 minutes post protein shake consumption

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

    Marker: insulin (ng/mL)

    Measured: Insulin measured 120 minutes post protein shake consumption

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

    Marker: insulin (ng/mL)

    Measured: Insulin measured 180 minutes post protein shake consumption

  11. 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)

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

  12. 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)

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

  13. 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)

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

  14. 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)

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

  15. 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)

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

  16. 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)

    Measured: Peptide tyrosine tyrosine measured 10 minutes prior to protein shake consumption

  17. 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)

    Measured: Peptide tyrosine tyrosine measured 30 minutes post protein shake consumption

  18. 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)

    Measured: Peptide tyrosine tyrosine measured 60 minutes post protein shake consumption

  19. 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)

    Measured: Peptide tyrosine tyrosine measured 120 minutes post protein shake consumption

  20. 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)

    Measured: Peptide tyrosine tyrosine measured 180 minutes post protein shake consumption

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

    Markers: ghrelin (pg/mL)

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

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

    Markers: ghrelin (pg/mL)

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

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

    Markers: ghrelin (pg/mL)

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

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

    Markers: ghrelin (pg/mL)

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

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

    Markers: ghrelin (pg/mL)

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

  26. 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)

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

  27. 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)

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

  28. 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)

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

  29. 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)

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

  30. 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)

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

  31. 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)

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

  32. 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)

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

Secondary outcomes (1)
  1. 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)

    Measured: VAS for Palatability collected immediately after protein shake consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start20 Jul 2018
  3. Primary completion19 Feb 2021
  4. Study completion19 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
single-blind, randomised, triple crossover
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04876495
Sponsor's protocol ID
VRE1516-1375
Acronym
PROTEIN
Status last verified
May 2021
First submitted
28 Apr 2021
Last updated
6 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Whey protein isolate, Potato protein isolate and Rice protein isolate in people with Appetite and General Nutritional Disorders, run by University of Westminster at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.

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