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Pre-diabetesNCT02933424

Project Plant Protein: the P3 Study in Humans

A study testing Protein Powder in people with Pre-diabetes and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

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

The objective of this study is to compare the effects of adding three plant-based proteins (rice, oats and pea proteins) to a breakfast beverage on the glycemic response, appetite and subsequent food intake of healthy adults. Read more about this study

Who is it for?
Ages 21 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pre-diabetes, Obesity
What is being tested?
Protein Powder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSingapore
Study dates
Sep 2016to 26 Oct 2017
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 21 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males
  • BMI 18.5-24.9kgm-2
  • eating all meals (5 days/week)

Who cannot join

  • major chronic disease such as heart disease, cancer, hypertension or diabetes mellitus
  • have gout
  • have food allergies
  • are taking insulin or drugs known to affect metabolism, appetite and body fat distribution,
  • have weight change of >5kg in the past 3 months
  • have major medical or surgical event requiring hospitalisation within the preceding three months
Show all 9Show fewer
  • are on a weight loss regime, and presence of disease or drugs which influence digestion and absorption of nutrients
  • smokers,
  • individuals who take part in sports at competitive/endurance levels

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Clinical Nutrition Research Centre

    Singapore

Other trials in Singapore

About this study

Official title: The Effects of Plant Proteins on Blood Glucose & Amino Acid Levels and Satiety in Humans

The objective of this study is to compare the effects of adding three plant-based proteins (rice, oats and pea proteins) to a breakfast beverage on the glycemic response, appetite and subsequent food intake of healthy adults.

Read the detailed description

A diet or a meal higher in dietary protein has been reported to promote satiety and suppress food intake in humans in several previous studies. It was suggested that the presence of amino acid in the blood as a result of higher protein intake served as signals that suppress appetite in humans. More recently, it has been observed that incomplete or lower quality proteins, i.e. those missing one or more essential amino acids, may suppress hunger more than complete proteins, as the ingestion of incomplete proteins in the long term may lead to deficiency of essential amino acids. Plant proteins are generally considered incomplete protein when compared to animal proteins, which mean that plant protein may have higher appetite-suppressing effects.

Dietary carbohydrates are the most potent stimuli of insulin secretion. However, the addition of dietary protein in a carbohydrate-rich meal has been shown to further stimulate insulin release.The insulinotropic effect of dietary protein is thought to be attributed to the branched-chain amino acid (BCAA) content of the protein-rich meal. Interestingly, there is a hierarchy of effects induced by protein from different sources. For example, milk protein has been shown to be superior to fish or plant protein in stimulating insulin secretion following a meal.Even within milk protein, whey protein stimulated insulin secretion more than casein protein. One of the factors that distinguish whey from casein proteins was the digestibility or the digestion rate of these proteins. Protein that is digested faster appear to increase blood amino acid levels faster, and increase insulin release faster.This implies that plant proteins that have lower digestibility rate relative to animal proteins may have lower insulinotropic effects, and the effective dose required to achieve optimal insulin secretion may be different from animal protein and warrants further investigation. In addition, the amino acid profile (in addition to lower digestibility) of plant proteins may differ from animal protein, especially the BCAA content that is associated with the stimulation of insulin secretion.

Dietary patterns and cuisines vary between countries and cultures. Unlike in the Western countries, plant-based foods are more commonly consumed in an Asian cuisine. Based on the statistics released by Food and Agriculture Organization, cereals and meat are the top two protein sources in both Western (29.1% and 26.4% respectively) and Asian (58.8% and 8.6% respectively) countries. The third major source of protein is dairy (16.7%) in Western countries, and pulses in Asia (7.4%). In addition, vegetarianism is widely practiced in Asian countries. Studies investigating the appetitive and the blood glucose regulating effects of dietary protein have been focused predominantly in animal protein, with a number of studies included plant-based protein such as soy protein. Since cereals and pulses are an important part of an Asian cuisine, it is important to understand and compare the effects of proteins from these sources on blood glucose and appetite regulation. Since the amino acid profile and the digestibility of these plant-based proteins differ from animal protein, it is important to also understand the effective dose that exerts optimal effects.

Being tested
Protein Powder
Medical subject headings
Glucose Intolerance, Obesity

What participants receive

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

  • Protein PowderDietary supplement

Study groups in NCT02933424
Study groupRoleWhat they receive
Control beverage with no protein powderNo interventionStandard breakfast drink with no protein powder added
Beverage with Rice protein powder 25 gramsExperimentalStandard breakfast drink with 25 grams of rice protein powder.
Receives: Dietary Supplement: Protein Powder
Beverage with Pea protein powder 25 gramsExperimentalStandard breakfast drink with 25 grams of pea protein powder.
Receives: Dietary Supplement: Protein Powder
Beverage with Oats protein powder 25 gramsExperimentalStandard breakfast drink with 25 grams of Oats protein powder.
Receives: Dietary Supplement: Protein Powder

What is being measured

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

  1. Change in blood glucose

    Blood glucose measured up to 180 minutes

    Measured: Up to 180 minutes

  2. Change in blood insulin

    Blood insulin measured up to 180 minutes

    Measured: Up to 180 minutes

  3. Change in gut hormones

    Blood gut hormones measured up to 180 minutes

    Measured: Up to 180 minutes

  4. Change in body weight

    Body weight measured with a Bio-electrical impedance scale

    Measured: At baseline

  5. Change in body composition

    Fat% measured with a Bio-electrical impedance scale

    Measured: At baseline

Secondary outcomes (3)
  1. Change in subjective appetite ratings

    Appetite ratings measured up to 180 minutes

    Measured: Up to 180 minutes

  2. Change in plasma amino acid

    Blood amino acid profile measured up to 180 minutes

    Measured: Up to 180 minutes

  3. Meal challenge

    Ad libitum meal challenge at 180-minutes

    Measured: At 180 minutes

Timeline

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

  1. First posted14 Oct 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion26 Oct 2017
  4. Study completion26 Oct 2017

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
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02933424
Sponsor's protocol ID
2016/00796
Other IDs
2016
Status last verified
Jan 2018
First submitted
27 Sep 2016
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • Tan SY, Siow PC, Peh E, Henry CJ. Influence of rice, pea and oat proteins in attenuating glycemic response of sugar-sweetened beverages. Eur J Nutr. 2018 Dec;57(8):2795-2803. doi: 10.1007/s00394-017-1547-3. Epub 2017 Sep 30.

    PubMed 28965176

Questions about this trial

What is this clinical trial studying?

A study testing Protein Powder in people with Pre-diabetes and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

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 3 inclusion and 9 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 25 Jan 2018. 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 Singapore. 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?

Change in blood glucose (time frame: Up to 180 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02933424, which also lists 1 linked publication.

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 25 Jan 2018.

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