Comprehensive Study of Biochemical Response to Alternative Protein Sources in Different Food Matrices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Plasma amino acids
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •30-65 years of age
- •BMI >25 kg/m2 and <35 kg/m2
- •Waist circumference with females >85 cm and with males >100 cm
Exclusion Criteria
- •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
Arms & Interventions
Meal 1
Meal with plant protein and fiber in an intact structure
Intervention: High fiber and protein meal (Dietary Supplement)
Meal 2
Meal with plant protein and fiber, where the cell structure is broken
Intervention: High fiber and protein meal (Dietary Supplement)
Meal 3
Low protein and low fiber cereal
Intervention: Control (Dietary Supplement)
Meal 4
High protein and low carbohydrate bread with animal proteins
Intervention: High fiber and protein meal (Dietary Supplement)
Meal 5
High protein and low carbohydrate bread with plant protein
Intervention: High fiber and protein meal (Dietary Supplement)
Outcomes
Primary Outcomes
Plasma amino acids
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)