Clinical trial NCT06623812: Alternative ProtEin Satiety Study (APES Study)
Official title: Satiety Responses of Meals Consisting of Different Protein Sources
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Male Adults Participants
Keywords: Satiety
Alternative Protein
Protein Quality
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2024-10-02
Enrollment: 50
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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 (\&lt;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

Primary outcomes:
measure: Post-Prandial Sensor Glucose Readings
timeFrame: 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
measure: Oral processing behaviour
timeFrame: 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
measure: Change in Post breakfast satiety responses
timeFrame: 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
measure: Ad-libitum snack intake
timeFrame: 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
measure: Subsequent food intake post test meal
timeFrame: 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
measure: Change in Post lunch satiety responses
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Singapore Institute of Food and Biotechnology Innovation (SIFBI)
name: Pey Sze Teo, PhD
role: PRINCIPAL_INVESTIGATOR
References: