Alternative ProtEin Satiety Study (APES Study)

NCT06623812 | Not Yet Recruiting

• 1 other identifier: 2024-089
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Male Adults Participants

Keywords

Satiety; Alternative Protein; Protein Quality

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

Animal Protein

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

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

Animal Protein; Plant Protein 1 with lower DIAAS Score (lower protein quality); Plant Protein 2 with higher DIAAS Score (higher protein quality)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Officials

• Pey Sze Teo, PhD

  Singapore Institute of Food and Biotechnology Innovation (SIFBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pey Sze Teo, PhD

CONTACT

+65 64070497; Teo_Pey_Sze@sifbi.a-star.edu.sg

Amanda Lim, BSc

CONTACT

64070423; amanda_lim@sifbi.a-star.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist I

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share