A Study of Biochemical Response to Alternative Proteins
- Conditions
- Postprandial HyperglycemiaOverweight and ObesityType2diabetes
- Interventions
- Dietary Supplement: High fiber and protein mealDietary Supplement: Control
- Registration Number
- NCT06253728
- Lead Sponsor
- University of Eastern Finland
- 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:
1. 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.
2. 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.
3. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 30-65 years of age
- BMI >25 kg/m2 and <35 kg/m2
- Waist circumference with females >85 cm and with males >100 cm
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Meal 1 High fiber and protein meal Meal with plant protein and fiber in an intact structure Meal 3 Control Low protein and low fiber cereal Meal 2 High fiber and protein meal Meal with plant protein and fiber, where the cell structure is broken Meal 4 High fiber and protein meal High protein and low carbohydrate bread with animal proteins Meal 5 High fiber and protein meal High protein and low carbohydrate bread with plant protein
- Primary Outcome Measures
Name Time Method Plasma amino acids 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 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 Outcome Measures
Name Time Method Plasma glucose 0-4 hours Plasma glucose is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Inflammation marker 0-4 hours Plasma IL-22 is measured at 0, 60, 240 minutes after consuming the study meal.
Plasma triglycerides 0-4 hours Plasma triglycerides are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Plasma free fatty acids 0-4 hours Plasma free fatty acids are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Plasma insulin 0-4 hours Plasma insulin is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Urine para-cresol 24 hours The amount of para-cresol is measured from urine sample at 24 hours after consuming the study meal.
Trial Locations
- Locations (1)
University of Eastern Finland
🇫🇮Kuopio, Finland