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COMPLETEDNA

Glutenfree, Gut Microbiota and Metabolic Regulation

The Effect of Gluten-free Diet on Gut Microbiota and Metabolic Regulation in People With Coeliac Disease

NCT05135923•Oslo Metropolitan University

Summary

High intake of dietary fiber provides health benefits and reduces the risk of developing cardio-metabolic diseases, such as type 2 diabetes (T2D) and cardiovascular disease (CVD). The intake of fiber is below the recommendations worldwide. In Norway, bread and cereals represent a major source of fiber. A low fiber intake is evident for people with celiac disease due to the removal of wheat, rye and barley from the diet. We therefore need to increase our knowledge in relation to fiber-rich food that will be tolerated also by people with celiac disease. The aim of the study is to investigate the effect of fiber rich gluten free products on blood glucose levels compared to benchmark gluten free products.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy individuals with celiac disease
•BMI 18.5-27
•18-65 years

Exclusion Criteria

•chronic metabolic diseases, such as diabetes (type 1 and 2), cardiovascular diseases, cancer the last six months
•gut diseases, including chron's disease, ulcerative colite
•food allergies or intolerance, except for coliac disease
•pregnant and/or lactating
•smokers
•BMI \<18.5 and \>27
•planned weight reduction and/or 5% weight change the last three months
•blood donor the last two months and during the study period
•not willing to stop using dietary supplements, including probiotic products, cod liver oil etc, four weeks before and throughout the study
•use of antibiotics \< three months before study start and throughout the study period
+2 more criteria

Locations (1)

Oslo Metropolitan University

Oslo, Norway

Key Dates

Start Date

September 1, 2021

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2022

Last Updated

August 12, 2024

Enrollment

ACTUAL participants

Conditions

Celiac Disease

Interventions

Randomized, controlled trial (RCT) with parallel arms and double blinded

DIETARY_SUPPLEMENT

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RECRUITINGNA

GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)

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RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Glutenfree, Gut Microbiota and Metabolic Regulation

Inclusion Criteria

Exclusion Criteria

Study of DONQ52 in Active Celiac Disease

GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)

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