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Completed

NCT Number: NCT05135923

Glutenfree, Gut Microbiota and Metabolic Regulation

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo Metropolitan University

Oslo, 0130, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Dietary Supplement

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

Primary outcomes

  1. Concentration of blood glucose

    Time frame: 3 weeks

    Blood analyses of glucose (fasting and post-prandial (after an OGTT)) before and after intervention with benchmark versus optimized gluten-free products.

Secondary outcomes

  1. Concentration of blood cholesterol, triglycerides, fatty acids, C-peptide

    Time frame: 3 weeks

    Blood analyses of total cholesterol, triglycerides, fatty acids, and C-peptide (fasting) before and after intervention with benchmark versus optimized gluten-free products.

  2. Concentration of blood inflammatory markers

    Time frame: 3 weeks

    Blood analyses of inflammatory markers (fasting) before and after intervention with benchmark versus optimized gluten-free products.

  3. Feces microbiota analyses performed with Bio-Me's Precision Microbiome Profiling platform (PMP)

    Time frame: 3 weeks

    Feces analyses of microbiota before and after intervention with benchmark versus optimized gluten-free products.

  4. Gastrointestinal Symptoms Rating Scale-Irritable bowl syndrome (GSRS-IBS)

    Time frame: 3 weeks

    GSRS-IBS analyses before and after intervention with benchmark versus optimized gluten-free products with the following response scale: 1 (no discomfort at all) to 7 (very severe discomfort)

  5. Concentration of satiety hormones in blood

    Time frame: 3 weeks

    Blood analyses of satiety hormones (fasting) before and after intervention with benchmark versus optimized gluten-free products.

  6. Bristol Stool Chart (BSC)

    Time frame: 3 weeks

    BSC analyses before and after intervention with benchmark versus optimized gluten-free products with a scale from 1 (separate hard lumps, like nuts) to 7 (watery, no solid pieces).

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Det Glutenfrie Verksted
  • University of Oslo

Registry information

Official study title

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

Acronym: GRAIN

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2021
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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