临床试验/NCT07104461

NCT07104461已完成不适用

A Single-blind Randomised Study to Test the Effects of Protein-enriched Breakfast Meals With Varying Protein Sources Compared to a Standard Meal on the Regulation of Appetite and Satiety in Healthy Human Volunteers

University of Westminster1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2023年6月9日最近更新: 2025年8月21日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Westminster
入组人数: 12
试验地点: 1
主要终点: To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate and meal replacement shake on glucose levels (T30)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

INTRODUCTION: Obesity is a global epidemic, with over 2.5 billion adults being classified as overweight and 890 million of these classified as obese. Overweight and obesity are the 5th cause of mortality globally, with an estimated 2.8 million related deaths among adults. The rising prevalence of obesity in adults is leading to a rise in the prevalence of type 2 diabetes, with an estimated 462 million individuals affected globally. At present, the most effective non-surgical obesity treatments offered by the National Health Service (NHS) are the subcutaneously administered GLP-1 receptor agonists. However, they may present potentially serious side effects following short-term use, and there are still uncertainties around long-term use side effects. Therefore, a dietary approach to weight loss or maintenance seems preferable.

Increasing protein intake is a commonly applied nutritional approach to appetite regulation. The increase in protein intake is often achieved by supplementation, using proteins isolated from dairy, such as whey and casein. However, with more individuals following plant-based diets over recent years, the interest in plant-based protein supplements has increased. While dairy-based proteins are well-characterised, the appetite regulatory characteristics of plant-based proteins have not yet been fully elucidated.

The main aim of this study is to investigate the effects of protein-enriched food items on appetite regulation compared to a standard carbohydrate-rich meal. Furthermore, this study will investigate whether there are any differences in appetite-related hormonal responses to a plant protein-containing meal replacement shake (containing rice and pea protein) or a potato protein-enriched standard carbohydrate-based meal compared to a whey protein-enriched standard carbohydrate-based meal.

详细描述

Intervention study with four treatment groups in a randomised, single-blind, quadruple crossover design.

Healthy male participants (between the ages of 18 to 50 years) will receive four different isocaloric intervention meals with the same mass, on separate visit days, following a minimum of 8 hours overnight fast. The four meals will contain oat porridge prepared with coconut milk as a control, oat porridge prepared with coconut milk with added whey or potato protein isolates, and a complete meal replacement shake containing plant-based pea and rice proteins. The intervention meals will be followed by a standardised pasta-based ready meal after the 3-hour observation period. All participants will observe at least a two-day washout period between the differing treatments.

Biological samples (blood) will be collected at various times during the visit. Blood samples will be collected at baseline 0 min prior (T0), then at 30 min (T30), 60 min (T60), 120 min (T120) and 180 min (T180) after the intervention meal consumption.

In addition, pertinent questionnaires, Visual Analogue Scale [VAS] for assessing satiety and VAS for assessing intervention meals' perception and palatability will be collected. VAS for the assessment of satiety will be collected at T0, T30, T60, T120 and T180 and VAS assessing the perception and palatability of the intervention meals will be collected immediately following meal consumption.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Single (Participant)

盲法说明

Single

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Males (18-50 years of age)
•Lean and Overweight subjects (BMI 18.5 - 30 kg/m2)
•Sedentary and physically active subjects
•Healthy subjects

排除标准

•<18, >50 years
•Consumption of >14 units of alcohol/week
•Allergies to test foods/drinks
•Illnesses or on medication (with a possible effect on taste and/or appetite)
•Devices such as pacemakers
•Gastrointestinal disorders
•Eating disorders

研究组 & 干预措施

Meal replacement shake

Active Comparator

(total protein 40 g, mostly from pea protein and brown rice protein isolates)

干预措施: Meal replacement shake (Dietary Supplement)

Oat porridge

Sham Comparator

Control Meal (9.5 g total protein)

干预措施: Oat porridge (Other)

Oat porridge with whey protein

Active Comparator

(total protein 40.5 g; of which whey protein isolate contributed 34.2 g of protein)

干预措施: Whey protein isolate (Dietary Supplement)

Oat porridge with potato protein

Active Comparator

(total protein 40.6 g; of which potato protein isolate contributed 34.39 g of protein)

干预措施: Potato protein isolate (Dietary Supplement)

结局指标

主要结局

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate and meal replacement shake on glucose levels (T30)

时间窗: Glucose measured 30 minutes post meal consumption

Glucose (mmol/L)

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucose levels (T60)

时间窗: Glucose measured 60 minutes post meal consumption

Glucose (mmol/L)

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucose levels (T120)

时间窗: Glucose measured 120 minutes post meal consumption

Glucose (mmol/L)

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucose levels (T180)

时间窗: Glucose measured 180 minutes post meal consumption

Glucose (mmol/L)

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on insulin levels (T30)

时间窗: Insulin measured 30 minutes post meal consumption

Insulin (pmol/L)

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on insulin levels (T60)

时间窗: Insulin measured 160 minutes post meal consumption

Insulin (pmol/L)

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on insulin levels (T120)

时间窗: Insulin measured 120 minutes post meal consumption

Insulin (pmol/L)

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on insulin levels (T180)

时间窗: Insulin measured 180 minutes post meal consumption

Insulin (pmol/L)

To assess the acute effects of oat porridge, whey protein isolate, potato protein isolate, and meal replacement shake on glucagon-like peptide 1 levels (T30)

时间窗: Glucagon-like peptide 1 measured 30 minutes post meal consumption