Glutenfree, Gut Microbiota and Metabolic Regulation

Study Overview
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Brief Summary
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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.

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

Conditions
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Celiac Disease

Intervention / Treatment
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* Dietary Supplement: Randomized, controlled trial (RCT) with parallel arms and double blinded


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Benchmark gluten-free products<br>Products containing less than 6g fibre per 100g product. | Dietary Supplement: Randomized, controlled trial (RCT) with parallel arms and double blinded<br>* Experiment group receive optimized gluten free products (high in fiber and whole grain) compared to comparable benchmark gluten free products (control group).<br>|
| Experimental: Optimised gluten-free products<br>Products containing less than 6g fibre per 100g product. | Dietary Supplement: Randomized, controlled trial (RCT) with parallel arms and double blinded<br>* Experiment group receive optimized gluten free products (high in fiber and whole grain) compared to comparable benchmark gluten free products (control group).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of blood glucose | Blood analyses of glucose (fasting and post-prandial (after an OGTT)) before and after intervention with benchmark versus optimized gluten-free products. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of blood cholesterol, triglycerides, fatty acids, C-peptide | Blood analyses of total cholesterol, triglycerides, fatty acids, and C-peptide (fasting) before and after intervention with benchmark versus optimized gluten-free products. | 3 weeks | 
| Concentration of blood inflammatory markers | Blood analyses of inflammatory markers (fasting) before and after intervention with benchmark versus optimized gluten-free products. | 3 weeks | 
| Feces microbiota analyses performed with Bio-Me's Precision Microbiome Profiling platform (PMP) | Feces analyses of microbiota before and after intervention with benchmark versus optimized gluten-free products. | 3 weeks | 
| Gastrointestinal Symptoms Rating Scale-Irritable bowl syndrome (GSRS-IBS) | 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) | 3 weeks | 
| Concentration of satiety hormones in blood | Blood analyses of satiety hormones (fasting) before and after intervention with benchmark versus optimized gluten-free products. | 3 weeks | 
| Bristol Stool Chart (BSC) | 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). | 3 weeks |