Comprehensive Study of Biochemical Response to Alternative Protein Sources in Different Food Matrices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Plasma amino acids
研究概览
简要总结
The overall objective of this research is to determine the digestive faith and health impact of protein and fiber rich foods in different food matrices in type 2 diabetes risk population. This is achieved by controlled postprandial intervention where plasma amino acids, lipids, glucose metabolism, bile acids and microbial metabolites are evaluated as well as fecal microbiota and metabolites.
详细描述
Detailed research aim of this controlled, randomized crossover postprandial clinical study are:
- To study the impact of complex plant- and animal-based foods on glucose metabolism, acute inflammation, and markers of microbial fermentation of fiber and proteins.
- To investigate the difference in the gut mediated metabolism induced by naturally occurring fiber fraction bound plant protein or by plant protein with added fiber when compared to animal protein.
- To conduct in vitro experiments using fecal samples from participants in the meal study to investigate the distinctions between different animal and plant proteins on both host and microbial metabolites, as well as the function of the gut barrier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-65 years of age
- •BMI >25 kg/m2 and <35 kg/m2
- •Waist circumference with females >85 cm and with males >100 cm
排除标准
- •Certain chronic diseases requiring regular medication (e.g., type 2 diabetes, chronic liver, kidney, thyroid, or gastrointestinal diseases)
- •Pregnancy or breastfeeding
- •Gluten-free or vegan diet
- •Use of antibiotics within the last 12 months
- •Gastrointestinal surgery within the last two years
- •High alcohol consumption
结局指标
主要结局
Plasma amino acids
时间窗: 0-4 hours
Plasma free amino acids were measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Gut derived metabolites
时间窗: 0-24 hours
Gut derived metabolites are measured with untargeted metabolomics from plasma at 12 hours after consuming the study meal. From fecal sample, the metabolomics are measured at 24 hours after consuming the study meal. Plasma short chain fatty acids are quantified at 12 hours after consuming the study meal.
次要结局
- Plasma glucose(0-4 hours)
- Inflammation marker(0-4 hours)
- Plasma triglycerides(0-4 hours)
- Plasma free fatty acids(0-4 hours)
- Plasma insulin(0-4 hours)
- Urine para-cresol(24 hours)