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Project Plant Protein: the P3 Study in Humans

Primary Purpose

Pre-diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Protein Powder
Sponsored by
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pre-diabetes

Eligibility Criteria

21 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control beverage with no protein powder

Beverage with Rice protein powder 25 grams

Beverage with Pea protein powder 25 grams

Beverage with Oats protein powder 25 grams

Arm Description

Standard breakfast drink with no protein powder added

Standard breakfast drink with 25 grams of rice protein powder.

Standard breakfast drink with 25 grams of pea protein powder.

Standard breakfast drink with 25 grams of Oats protein powder.

Outcomes

Primary Outcome Measures

Change in blood glucose
Blood glucose measured up to 180 minutes
Change in blood insulin
Blood insulin measured up to 180 minutes
Change in gut hormones
Blood gut hormones measured up to 180 minutes
Change in body weight
Body weight measured with a Bio-electrical impedance scale
Change in body composition
Fat% measured with a Bio-electrical impedance scale

Secondary Outcome Measures

Change in subjective appetite ratings
Appetite ratings measured up to 180 minutes
Change in plasma amino acid
Blood amino acid profile measured up to 180 minutes
Meal challenge
Ad libitum meal challenge at 180-minutes

Full Information

First Posted
September 27, 2016
Last Updated
January 24, 2018
Sponsor
Clinical Nutrition Research Centre, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT02933424
Brief Title
Project Plant Protein: the P3 Study in Humans
Official Title
The Effects of Plant Proteins on Blood Glucose & Amino Acid Levels and Satiety in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
October 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control beverage with no protein powder
Arm Type
No Intervention
Arm Description
Standard breakfast drink with no protein powder added
Arm Title
Beverage with Rice protein powder 25 grams
Arm Type
Experimental
Arm Description
Standard breakfast drink with 25 grams of rice protein powder.
Arm Title
Beverage with Pea protein powder 25 grams
Arm Type
Experimental
Arm Description
Standard breakfast drink with 25 grams of pea protein powder.
Arm Title
Beverage with Oats protein powder 25 grams
Arm Type
Experimental
Arm Description
Standard breakfast drink with 25 grams of Oats protein powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein Powder
Primary Outcome Measure Information:
Title
Change in blood glucose
Description
Blood glucose measured up to 180 minutes
Time Frame
Up to 180 minutes
Title
Change in blood insulin
Description
Blood insulin measured up to 180 minutes
Time Frame
Up to 180 minutes
Title
Change in gut hormones
Description
Blood gut hormones measured up to 180 minutes
Time Frame
Up to 180 minutes
Title
Change in body weight
Description
Body weight measured with a Bio-electrical impedance scale
Time Frame
At baseline
Title
Change in body composition
Description
Fat% measured with a Bio-electrical impedance scale
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Change in subjective appetite ratings
Description
Appetite ratings measured up to 180 minutes
Time Frame
Up to 180 minutes
Title
Change in plasma amino acid
Description
Blood amino acid profile measured up to 180 minutes
Time Frame
Up to 180 minutes
Title
Meal challenge
Description
Ad libitum meal challenge at 180-minutes
Time Frame
At 180 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
28965176
Citation
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.
Results Reference
derived

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Project Plant Protein: the P3 Study in Humans

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