Alternative ProtEin Satiety Study (APES Study) (APES)

Satiety Responses of Meals Consisting of Different Protein Sources

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Male Adults Participants
• Intervention / Treatment: Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pey Sze Teo, PhD; Phone Number: +65 64070497; Email: Teo_Pey_Sze@sifbi.a-star.edu.sg
• Study Contact Backup: Name: Amanda Lim, BSc; Phone Number: 64070423; Email: amanda_lim@sifbi.a-star.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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
Active Comparator: 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.	Other: 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
Active Comparator: 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Prandial Sensor Glucose Readings	A continuous monitoring glucose sensor will be used to measure participants sensor glucose readings. The post-prandial sensor glucose readings 2-3h post meal will be used as an objective indicator of postprandial self-reported hunger and subsequent energy intake.	During the test day 2, 5, 8, up to 48 hours per test day. There is a one-week wash-out period between test days
Oral processing behaviour	Participants will be video recorded during the lunch sessions to measure oral processing behavior (e.g., derived from number of bites, chews, swallows and eating duration) of the fixed portion test meals using an annotation software	During test day 2, 5 and 8, up to 20 minutes per test day. There is a one-week wash-out period between test days
Change in Post breakfast satiety responses	Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at: Not at all (0) to Extremely (100), where a higher score will indicate greater intensity.	During test day 2, 5 and 8, at 15- or 30-minutes intervals, up to 4 hours each test day. There is a one-week wash-out period between test days
Ad-libitum snack intake	Participants will be asked to eat an ad-libitum amount of snack 2h post lunch. The amount of food consumed will be weighed.	During test day 2, 5, and 8, up to 15 minutes per test day. There is a one-week wash-out period between test days
Subsequent food intake post test meal	Participants will be asked to bring a food dairy home to record their food and beverage intake for the rest of the test day. This is to assess participants calorie intake for the remaining day on the test session.	During test day 2, 5 and 8, up to participant's bedtime per test day (before 12am midnight of the next day). There is a one-week wash-out period between test days
Change in Post lunch satiety responses	Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at: Not at all (0) to Extremely(100), where a higher score will indicate greater intensity.	During test day 2, 5 and 8, at 15- or 30-minutes intervals, up to 2 hours each test day. There is a one-week wash-out period between test days

Collaborators and Investigators

• Sponsor: Singapore Institute of Food and Biotechnology Innovation
• Investigators: Principal Investigator: Pey Sze Teo, PhD, Singapore Institute of Food and Biotechnology Innovation (SIFBI)

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Satiety; Protein Quality; Alternative Protein
• Other Study ID Numbers: 2024-089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No