A Study of Biochemical Response to Alternative Proteins (COBRA)

University of Eastern Finland

Status: Enrolling

Conditions: Type2diabetes; Postprandial Hyperglycemia; Overweight and Obesity

Treatments: Dietary Supplement: Control; Dietary Supplement: High fiber and protein meal

Study type: Interventional

Funder types: Other

Identifiers

NCT06253728

A80406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 5 patient groups, including a placebo group

Meal 1

Experimental group

Description:

Meal with plant protein and fiber in an intact structure

Treatment:

Dietary Supplement: High fiber and protein meal

Meal 2

Experimental group

Description:

Meal with plant protein and fiber, where the cell structure is broken

Treatment:

Dietary Supplement: High fiber and protein meal

Meal 3

Placebo Comparator group

Description:

Low protein and low fiber cereal

Treatment:

Dietary Supplement: Control

Meal 4

Experimental group

Description:

High protein and low carbohydrate bread with animal proteins

Treatment:

Dietary Supplement: High fiber and protein meal

Meal 5

Experimental group

Description:

High protein and low carbohydrate bread with plant protein

Treatment:

Dietary Supplement: High fiber and protein meal