NCT06253728

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

January 30, 2024

Last Update Submit

February 9, 2024

Conditions

Postprandial HyperglycemiaOverweight and ObesityType2diabetes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Plasma glucose

    0-4 hours

  • Inflammation marker

    0-4 hours

  • Plasma triglycerides

    0-4 hours

  • Urine para-cresol

    24 hours

  • Plasma insulin

    0-4 hours

  • +1 more secondary outcomes

Study Arms (5)

Meal 1

EXPERIMENTAL

Meal with plant protein and fiber in an intact structure

Dietary Supplement: High fiber and protein meal

Meal 2

EXPERIMENTAL

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

Dietary Supplement: High fiber and protein meal

Meal 3

PLACEBO COMPARATOR

Low protein and low fiber cereal

Dietary Supplement: Control

Meal 4

EXPERIMENTAL

High protein and low carbohydrate bread with animal proteins

Dietary Supplement: High fiber and protein meal

Meal 5

EXPERIMENTAL

High protein and low carbohydrate bread with plant protein

Dietary Supplement: High fiber and protein meal

Interventions

High fiber and protein mealDIETARY_SUPPLEMENT

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

Meal 1Meal 2Meal 4Meal 5
ControlDIETARY_SUPPLEMENT

The control meal is low fiber and low protein meal.

Meal 3

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • BMI \>25 kg/m2 and \<35 kg/m2
  • Waist circumference with females \>85 cm and with males \>100 cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, 70211, Finland

RECRUITING

MeSH Terms

Conditions

HyperglycemiaOverweightObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marjukka Kolehmainen, Professor

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjukka Kolehmainen, Professor

CONTACT

0403553617marjukka.kolehmainen@uef.fi

Moona Partanen, Msc

CONTACT

+358 504759536moona.partanen@uef.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 12, 2024

Study Start

January 18, 2024

Primary Completion

June 3, 2024

Study Completion

December 31, 2025

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)