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A Study of Biochemical Response to Alternative Proteins

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06253728
Acronym
COBRA
Enrollment
24
Registered
2024-02-12
Start date
2024-01-18
Completion date
2025-12-31
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity, Postprandial Hyperglycemia, Type2diabetes

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.

Interventions

DIETARY_SUPPLEMENTHigh 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_SUPPLEMENTControl

The control meal is low fiber and low protein meal.

Sponsors

University of Eastern Finland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma amino acids0-4 hoursPlasma free amino acids were measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Gut derived metabolites0-24 hoursGut 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

MeasureTime frameDescription
Plasma triglycerides0-4 hoursPlasma triglycerides are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Urine para-cresol24 hoursThe amount of para-cresol is measured from urine sample at 24 hours after consuming the study meal.
Plasma glucose0-4 hoursPlasma glucose is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Plasma free fatty acids0-4 hoursPlasma free fatty acids are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Plasma insulin0-4 hoursPlasma insulin is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Inflammation marker0-4 hoursPlasma IL-22 is measured at 0, 60, 240 minutes after consuming the study meal.

Countries

Finland

Contacts

Primary ContactMarjukka Kolehmainen, Professor
marjukka.kolehmainen@uef.fi0403553617
Backup ContactMoona Partanen, Msc
moona.partanen@uef.fi+358 504759536

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026