A Study of Biochemical Response to Alternative Proteins

NCT ID: NCT06253728

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-18

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Postprandial Hyperglycemia Overweight and Obesity Type2diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Meal 1

Meal with plant protein and fiber in an intact structure

Group Type EXPERIMENTAL

High fiber and protein meal

Intervention Type DIETARY_SUPPLEMENT

In the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure.

Meal 2

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

Group Type EXPERIMENTAL

High fiber and protein meal

Intervention Type DIETARY_SUPPLEMENT

In the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure.

Meal 3

Low protein and low fiber cereal

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

The control meal is low fiber and low protein meal.

Meal 4

High protein and low carbohydrate bread with animal proteins

Group Type EXPERIMENTAL

High fiber and protein meal

Intervention Type DIETARY_SUPPLEMENT

In the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure.

Meal 5

High protein and low carbohydrate bread with plant protein

Group Type EXPERIMENTAL

High fiber and protein meal

Intervention Type DIETARY_SUPPLEMENT

In the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Control

The control meal is low fiber and low protein meal.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marjukka Kolehmainen, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

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University of Eastern Finland

Kuopio, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Marjukka Kolehmainen, Professor

Role: CONTACT

0403553617

Moona Partanen, Msc

Role: CONTACT

+358 504759536

Facility Contacts

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Moona Partanen

Role: primary

+358440101198

Marjukka Kolehmainen

Role: backup

0403553617

Other Identifiers

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A80406

Identifier Type: -

Identifier Source: org_study_id

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