Alternative ProtEin Satiety Study (APES Study)

NCT ID: NCT06623812

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2024-12-31

Brief Summary

This project aims to study the effects of different protein quality (i.e. high vs. low) and protein sources (i.e. plant protein vs. conventional animal protein) on post-meal satiety and satisfaction. The protein quality score of meals will be calculated using the published digestible indispensable amino acid score (DIAAS). The proposed study will investigate the link between protein quality, protein source, and the post-meal satiety responses, using a realistic lunch meal approach, in humans. Other than the self-reported visual analogue scale (VAS) satiety response, the postprandial glucose dips (i.e. 2-3hours post-meal) will be collected by continuous glucose monitoring (CGMS) as an objective indicator of postprandial self-reported hunger and subsequent energy intake. In addition, the oral processing behaviours of participants will be captured and compared between the test meals.

Detailed Description

Aim: To investigate how differences in protein quality (i.e. high vs low quality) and protein sources (i.e. plant vs animal proteins) influence the satisfaction, satiety responses (fullness over the time) and subsequent food intake.

Conditions

Healthy Male Adults Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Animal Protein

A standardized typical lunch test meal consists of an animal-based protein source (Animal Protein). The total weight of meal, total energy served, as well as energy from macronutrients are standardized across the three test meals.

Group Type: ACTIVE_COMPARATOR

Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake

Intervention Type: OTHER

Investigate differences in post meal satiety and subsequent post meal energy intake after consuming fixed portion meals with different protein source and/ or different protein quality

Plant Protein 1 with lower DIAAS Score (lower protein quality)

A standardized typical lunch test meal consists of a plant-based protein source with a lower DIAAS Score (Plant protein 1- lower protein quality). The total weight of meal, total energy served, as well as energy from macronutrients are standardized across the three test meals.

Group Type: ACTIVE_COMPARATOR

Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake

Intervention Type: OTHER

Investigate differences in post meal satiety and subsequent post meal energy intake after consuming fixed portion meals with different protein source and/ or different protein quality

Plant Protein 2 with higher DIAAS Score (higher protein quality)

A standardized typical lunch test meal consists of a plant-based protein source with a higher DIAAS Score (Plant protein 2- higher protein quality). The total weight of meal, total energy served, as well as energy from macronutrients are standardized across the three test meals.

Group Type: ACTIVE_COMPARATOR

Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake

Intervention Type: OTHER

Investigate differences in post meal satiety and subsequent post meal energy intake after consuming fixed portion meals with different protein source and/ or different protein quality

Interventions

Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake

Investigate differences in post meal satiety and subsequent post meal energy intake after consuming fixed portion meals with different protein source and/ or different protein quality

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy male
• Aged between 21 and 50-year-old
• Are of normal weight (BMI 18-25kg/m2)
• Stable weight for the previous 12 months (<5kg weight fluctuation in the previous year)
• Healthy dentition and ability to bite, chew and swallow normally
• No history of pain or discomfort in jaw movements or excessive teeth clenching or grinding
• No dental carries or periodontal disease
• Own a mobile device with Apple iOS Operating System version 15.0 -17.3 or Android Operating System version 10-14
• Have access to a data plan
• Comfortable with needles and insertion of a Continuous Glucose Monitoring System device for 3-7 days

Exclusion Criteria

• Are a smoker
• Have any dislikes, intolerances or allergies to foods or common food ingredients e.g. nuts, soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colourings or flavourings (e.g. MSG), etc.
• Have any specific dietary requirements and/ or restrictions (e.g. Vegan/ vegetarian, religious beliefs, lactose intolerance, calorie restricted diet etc.)
• Known sensitivity to medical-grade adhesives
• Bleeding disorders (e.g Hemophilia, von Willebrand disease etc.)
• Have sinus problems that affect your taste and smell
• Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Are taking insulin or medication known to affect your appetite or metabolism
• Have major chronic diseases such as heart disease, cancer or diabetes mellitus etc.
• Have active Tuberculosis (TB) or currently receiving treatment for TB
• Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
• Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
• Are enrolled in a concurrent research study judged not to be scientifically or medically compatible with this study

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore Institute of Food and Biotechnology Innovation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Teo Pey Sze

Senior Scientist I

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pey Sze Teo, PhD

Role: PRINCIPAL_INVESTIGATOR

Singapore Institute of Food and Biotechnology Innovation (SIFBI)

Central Contacts

Pey Sze Teo, PhD

Role: CONTACT

Teo_Pey_Sze@sifbi.a-star.edu.sg

+65 64070497

Amanda Lim, BSc

Role: CONTACT

amanda_lim@sifbi.a-star.edu.sg

64070423

Other Identifiers

2024-089

Identifier Type: -

Identifier Source: org_study_id