Project Plant Protein: the P3 Study in Humans

January 24, 2018 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore
        • Clinical Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
NO_INTERVENTION: Control beverage with no protein powder
Standard breakfast drink with no protein powder added
EXPERIMENTAL: Beverage with Rice protein powder 25 grams
Standard breakfast drink with 25 grams of rice protein powder.
EXPERIMENTAL: Beverage with Pea protein powder 25 grams
Standard breakfast drink with 25 grams of pea protein powder.
EXPERIMENTAL: Beverage with Oats protein powder 25 grams
Standard breakfast drink with 25 grams of Oats protein powder.

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
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
Change in body weight
Time Frame: At baseline
Body weight measured with a Bio-electrical impedance scale
At baseline
Change in body composition
Time Frame: At baseline
Fat% measured with a Bio-electrical impedance scale
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
Change in plasma amino acid
Time Frame: Up to 180 minutes
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
At 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ACTUAL)

October 26, 2017

Study Completion (ACTUAL)

October 26, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (ESTIMATE)

October 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

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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