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Clinical Trials/NCT06421194
NCT06421194
Recruiting
Not Applicable

Functional and Nutritional Plant-based Mixed Protein Study (FuN Protein Study)

Clinical Nutrition Research Centre, Singapore1 site in 1 country28 target enrollmentFebruary 23, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition, Healthy
Sponsor
Clinical Nutrition Research Centre, Singapore
Enrollment
28
Locations
1
Primary Endpoint
Gut hormones
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The study aims to investigate the effects of optimized plant protein mixtures versus their animal protein equivalents on satiety, protein metabolism, and overall metabolic health

Detailed Description

The research described in this application is crucial as it addresses a fundamental issue - the nutrition quality of plant-based diets. Plant-based diets are widely acknowledged for their health benefits as they are known to reduce disease risks and all-cause mortality. However, concerns about plant protein quality arise due to disparities in amino acid profiles, particularly their essential amino acid adequacy, which remains a challenge in adopting a plant-based protein diet as part of a healthy diet. Other challenges include low palatability, poor texture, flavor, and mouthfeel. To address this, the Singapore Institute of Food and Biotechnology Innovation (SIFBI) has developed Asian-centric plant-based food products by combining multiple plant-protein sources to emulate the amino acid profile of animal proteins. This approach aims to optimize plant-based diets by ensuring enhanced protein quantity and quality in a mixed meal, not only to encourage adaptation of plant based protein into daily meals for environmental sustainability but also with the long-term objectives to use diet as a means to improve metabolic health in the Asian demographics. This human study is designed to explore the effects of consuming optimized plant-protein-based products compared to conventional animal protein- based products on postprandial metabolism and overall metabolic health. The study is structured around several specific objectives: 1. Evaluate Nutritional Impact: The study aims to assess the nutritional efficacy of the investigational food products. This will involve measuring circulating amino acids and protein metabolism markers, such as blood urea and amino acid metabolites. Additionally, the study will examine the effects of these foods on overall metabolic health, including their impact on glycaemic response and inflammatory markers. 2. Investigate Postprandial Satiety: Another key aim is to explore the effects of investigational food items on postprandial appetite and satiety. This will help determine how these foods influence hunger and fullness sensations following consumption, which is crucial for understanding their potential role in weight management and metabolic regulation. 3. Investigate Consumer Acceptance: The study will also assess consumer acceptance of the investigational food products to identify the potential barriers. This includes evaluating the palatability of these products, as their taste, texture, and overall appeal are vital factors in determining their potential integration into regular diets. 4. Gain Mechanistic Insight: The study seeks to gain deeper mechanistic insights by systematically investigating changes in the postprandial circulating proteome. This analysis will enhance our understanding of the biological processes and pathways involved in the body's response to these food products post-consumption.

Registry
clinicaltrials.gov
Start Date
February 23, 2024
End Date
January 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
Clinical Nutrition Research Centre, Singapore
Responsible Party
Principal Investigator
Principal Investigator

Melvin Leow

Principal Investigator

Clinical Nutrition Research Centre, Singapore

Eligibility Criteria

Inclusion Criteria

  • Chinese ethnicity
  • Age between 21 to 45 years
  • Body Mass Index (BMI) between 18.5 to 27.5 kg/m2
  • English-literate
  • Exclusion criteria:
  • Having allergies or intolerances to any common food ingredients including eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, pea, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc.
  • Following special diets or having intentional dietary restrictions (e.g., vegetarians/vegans)
  • Having a dislike towards plant-based or chicken-based foods
  • Not willing to adhere to diet modification as in the study's instructions
  • Not willing to stop any strenuous activity during or within 24 hours of test days

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Gut hormones

Time Frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.

Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)

Glucose homeostasis

Time Frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.

Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (serum)

Free amino acids

Time Frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.

Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)

Protein utilization

Time Frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.

Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)

Markers related to general metabolic health

Time Frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.

Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)

Secondary Outcomes

  • Gastrointestinal Symptoms Questionnaire(The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.)
  • Untargeted proteomics(The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.)
  • Visual Analogue Scale Questionnaire(The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.)

Study Sites (1)

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