Alternative ProtEin Satiety Study (APES Study)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21-50
SponsorSingapore Institute of Food and Biotechnology Innovation

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

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

    Other intervention

    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

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Animal ProteinActive comparator 1 intervention
Group B: Plant Protein 1 with lower DIAAS Score (lower protein quality)Active comparator 1 intervention
Group C: Plant Protein 2 with higher DIAAS Score (higher protein quality)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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
2

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

Time frame
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
3

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.

Time frame
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
4

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.

Time frame
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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: