Glutenfree, Gut Microbiota and Metabolic Regulation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

- alcohol consume > 40 g/day.

- hormone treatment (except for contraceptives)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05135923
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oslo Metropolitan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Norway
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease

Arms & Interventions

Arms

Active Comparator: Benchmark gluten-free products

Products containing less than 6g fibre per 100g product.

Experimental: Optimised gluten-free products

Products containing less than 6g fibre per 100g product.

Interventions

Dietary Supplement: - Randomized, controlled trial (RCT) with parallel arms and double blinded

Experiment group receive optimized gluten free products (high in fiber and whole grain) compared to comparable benchmark gluten free products (control group).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Oslo Metropolitan University, Oslo, Norway

Status

Recruiting

Address

Oslo Metropolitan University

Oslo, , 0130

Site Contact

Vibeke Telle-Hansen, PhD

vtelle@oslomet.no

47 67 23 68 19

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