NCT06253728

A Study of Biochemical Response to Alternative Proteins

Comprehensive Study of Biochemical Response to Alternative Protein Sources in Different Food Matrices

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Eastern Finland · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postprandial Hyperglycemia
• Overweight and Obesity
• Type2diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High fiber and protein meal	In the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure.
DIETARY_SUPPLEMENT	Control	The control meal is low fiber and low protein meal.

Timeline

• Start date: 2024-01-18
• Primary completion: 2024-06-03
• Completion: 2025-12-31
• First posted: 2024-02-12
• Last updated: 2024-02-12

Locations

1 site across 1 country: Finland