- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02933424
Project Plant Protein: the P3 Study in Humans
The Effects of Plant Proteins on Blood Glucose & Amino Acid Levels and Satiety in Humans
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Singapore, Singapore
- Clinical Nutrition Research Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males
- BMI 18.5-24.9kgm-2
- eating all meals (5 days/week)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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NO_INTERVENTION: Control beverage with no protein powder
Standard breakfast drink with no protein powder added
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|
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EXPERIMENTAL: Beverage with Rice protein powder 25 grams
Standard breakfast drink with 25 grams of rice protein powder.
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EXPERIMENTAL: Beverage with Pea protein powder 25 grams
Standard breakfast drink with 25 grams of pea protein powder.
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EXPERIMENTAL: Beverage with Oats protein powder 25 grams
Standard breakfast drink with 25 grams of Oats protein powder.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in blood glucose
Time Frame: Up to 180 minutes
|
Blood glucose measured up to 180 minutes
|
Up to 180 minutes
|
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Change in blood insulin
Time Frame: Up to 180 minutes
|
Blood insulin measured up to 180 minutes
|
Up to 180 minutes
|
|
Change in gut hormones
Time Frame: Up to 180 minutes
|
Blood gut hormones measured up to 180 minutes
|
Up to 180 minutes
|
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Change in body weight
Time Frame: At baseline
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Body weight measured with a Bio-electrical impedance scale
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At baseline
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Change in body composition
Time Frame: At baseline
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Fat% measured with a Bio-electrical impedance scale
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At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in subjective appetite ratings
Time Frame: Up to 180 minutes
|
Appetite ratings measured up to 180 minutes
|
Up to 180 minutes
|
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Change in plasma amino acid
Time Frame: Up to 180 minutes
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Blood amino acid profile measured up to 180 minutes
|
Up to 180 minutes
|
|
Meal challenge
Time Frame: At 180 minutes
|
Ad libitum meal challenge at 180-minutes
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At 180 minutes
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/00796
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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