Alternative ProtEin Satiety Study (APES Study)

Официальное название

Satiety Responses of Meals Consisting of Different Protein Sources

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Post-Prandial Sensor Glucose Readings [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06623812 · 2024-089

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗