A Study of Biochemical Response to Alternative Proteins

Overweight and Obesity Clinical Trial

— COBRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253728
• Other study ID #: A80406
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of Eastern Finland
• Contact: Marjukka Kolehmainen, Professor
• Phone: 0403553617
• Email: marjukka.kolehmainen[@]uef.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2025
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Overweight
• Overweight and Obesity
• Postprandial Hyperglycemia

Intervention

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.
• Control
The control meal is low fiber and low protein meal.

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma amino acids	Plasma free amino acids were measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.	0-4 hours
Primary	Gut derived metabolites	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.	0-24 hours
Secondary	Plasma glucose	Plasma glucose is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.	0-4 hours
Secondary	Inflammation marker	Plasma IL-22 is measured at 0, 60, 240 minutes after consuming the study meal.	0-4 hours
Secondary	Plasma triglycerides	Plasma triglycerides are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.	0-4 hours
Secondary	Urine para-cresol	The amount of para-cresol is measured from urine sample at 24 hours after consuming the study meal.	24 hours
Secondary	Plasma insulin	Plasma insulin is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.	0-4 hours
Secondary	Plasma free fatty acids	Plasma free fatty acids are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.	0-4 hours