A Study of Biochemical Response to Alternative Proteins (COBRA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity; Postprandial Hyperglycemia; Type2diabetes
• Intervention / Treatment: Dietary supplement: High fiber and protein meal; Dietary supplement: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marjukka Kolehmainen, Professor; Phone Number: 0403553617; Email: marjukka.kolehmainen@uef.fi
• Study Contact Backup: Name: Moona Partanen, Msc; Phone Number: +358 504759536; Email: moona.partanen@uef.fi

Study Locations

• Finland
  • Kuopio, Finland, 70211
    • Recruiting
    • University of Eastern Finland
    • Contact: Moona Partanen; Phone Number: +358440101198; Email: moona.partanen@uef.fi
    • Contact: Marjukka Kolehmainen; Phone Number: 0403553617; Email: marjukka.kolehmainen@uef.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meal 1; Meal with plant protein and fiber in an intact structure	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.
Experimental: Meal 2; Meal with plant protein and fiber, where the cell structure is broken	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.
Placebo Comparator: Meal 3; Low protein and low fiber cereal	Dietary supplement: Control; The control meal is low fiber and low protein meal.
Experimental: Meal 4; High protein and low carbohydrate bread with animal proteins	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.
Experimental: Meal 5; High protein and low carbohydrate bread with plant protein	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose	Plasma glucose is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.	0-4 hours
Inflammation marker	Plasma IL-22 is measured at 0, 60, 240 minutes after consuming the study meal.	0-4 hours
Plasma triglycerides	Plasma triglycerides are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.	0-4 hours
Urine para-cresol	The amount of para-cresol is measured from urine sample at 24 hours after consuming the study meal.	24 hours
Plasma insulin	Plasma insulin is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.	0-4 hours
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

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Investigators: Principal Investigator: Marjukka Kolehmainen, Professor, University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): June 3, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Hyperglycemia; Overweight
• Other Study ID Numbers: A80406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No