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

NCT06421194 | Recruiting

• 1 other identifier: 2023/00944
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Nutrition, Healthy

Keywords

plant-based protein; Asian; diet; health outcomes; animal-based protein

Outcome Measures

Primary Outcomes (5)

• Free amino acids

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

  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.

• Protein utilization

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

  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.

• Glucose homeostasis

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

  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.

• Gut hormones

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

  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.

• Markers related to general metabolic health

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

  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.

Secondary Outcomes (3)

• 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.

• 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.

Study Arms (4)

Treatment 1 Animal-based protein meal

EXPERIMENTAL

Animal-based protein meal; Isoproteic at \~30g of total protein per meal. Siew mai (6 pieces) - steamed Ngoh Hiang (2 pieces) - oven baked

Other: Investigational meal 1 - Commercial animal-based protein foods [Siew mai (6 pieces) and Ngoh hiang (2 pieces)]

Treatment 2 Animal-based protein meal

EXPERIMENTAL

Animal-based protein meal; Isoproteic at \~30g of total protein per meal. Gyoza (11 pieces) - steamed Luncheon meat (5 pieces) - oven baked

Other: Investigational meal 2- Commercial animal-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)]

Treatment 3 Plant-based protein meal

EXPERIMENTAL

Plant-based protein meal; Isoproteic at \~30g of total protein per meal. Siew mai (6 pieces) - steamed Ngoh Hiang (1 piece cut into 2) - oven baked

Other: Investigational meal 3- Formulated plant-based protein foods [Siew mai (6 pieces) and Ngoh hiang (1 piece cut into 2)]

Treatment 4 Plant-based protein meal

EXPERIMENTAL

Plant-based protein meal; Isoproteic at \~30g of total protein per meal. Gyoza (11 pieces) - steamed Luncheon meat (5 pieces) - oven baked

Other: Investigational meal 4- Formulated plant-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)]

Interventions

Investigational meal 1 - Commercial animal-based protein foods [Siew mai (6 pieces) and Ngoh hiang (2 pieces)] OTHER

Participants consume a meal consisting of commercial animal-based protein foods (steamed Siew mai and oven-baked Ngoh hiang) in a fasted state.

Treatment 1 Animal-based protein meal

Investigational meal 2- Commercial animal-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)] OTHER

Participants consume a meal consisting of commercial animal-based protein foods (steamed Gyoza and oven-baked Luncheon meat) in a fasted state.

Treatment 2 Animal-based protein meal

Investigational meal 3- Formulated plant-based protein foods [Siew mai (6 pieces) and Ngoh hiang (1 piece cut into 2)] OTHER

Participants consume a meal consisting of formulated plant-based protein foods (steamed Siew mai and oven-baked Ngoh hiang) in a fasted state.

Treatment 3 Plant-based protein meal

Investigational meal 4- Formulated plant-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)] OTHER

Participants consume a meal consisting of formulated plant-based protein foods (Gyoza and Luncheon meat) in a fasted state.

Treatment 4 Plant-based protein meal

Eligibility Criteria

• Age: 21 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Chinese ethnicity
• Age between 21 to 45 years
• Body Mass Index (BMI) between 18.5 to 27.5 kg/m2
• English-literate

You may not qualify if:

• Smoking
• 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
• Having glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
• Having alcohol consumption on \> 4 days per week with ≥ 6 alcoholic drinks per week
• Having sustained elevation of blood pressure (\>160/95 mm Hg)
• HbA1c reading ≥ 6.5% (raised non-fasted/random HbA1c as defined by WHO/ IDF)
• Having previously undergone any gastrointestinal surgery or having history of gastrointestinal disorders
• Having a history of heart, liver, kidney, blood disorders (e.g., thalassemia) or thyroid dysfunctions
• Diabetic
• Having history of tuberculosis, HIV, Hepatitis B or Hepatitis C infections
• Having any prescription medication or any other alternative medicines or supplements (amino acids supplements, e.g. L-carnitine, glutamine and arginine) which may interfere with study measurements in the opinion of the study investigators

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

RECRUITING

Study Officials

• Melvin Leow, Professor

  Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melvin Leow, Professor

CONTACT

melvin_leow@sifbi.a-star.edu.sg

Wu Jia Yee, PhD

CONTACT

6407 0778; wu_jia_yee@sifbi.a-star.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized controlled crossover trial, where participants will undergo four sessions, each followed by a six-day wash-out period.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 20, 2024
• Study Start: February 23, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)