Glutenfree, Gut Microbiota and Metabolic Regulation
- Conditions
- Celiac Disease
- Interventions
- Dietary Supplement: Randomized, controlled trial (RCT) with parallel arms and double blinded
- Registration Number
- NCT05135923
- Lead Sponsor
- Oslo Metropolitan University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Healthy individuals with celiac disease
- BMI 18.5-27
- 18-65 years
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Benchmark gluten-free products Randomized, controlled trial (RCT) with parallel arms and double blinded Products containing less than 6g fibre per 100g product. Optimised gluten-free products Randomized, controlled trial (RCT) with parallel arms and double blinded Products containing less than 6g fibre per 100g product.
- Primary Outcome Measures
Name Time Method Concentration of blood glucose 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 Outcome Measures
Name Time Method Concentration of blood cholesterol, triglycerides, fatty acids, C-peptide 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.
Concentration of blood inflammatory markers 3 weeks Blood analyses of inflammatory markers (fasting) before and after intervention with benchmark versus optimized gluten-free products.
Concentration of satiety hormones in blood 3 weeks Blood analyses of satiety hormones (fasting) before and after intervention with benchmark versus optimized gluten-free products.
Bristol Stool Chart (BSC) 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).
Gastrointestinal Symptoms Rating Scale-Irritable bowl syndrome (GSRS-IBS) 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)
Feces microbiota analyses performed with Bio-Me's Precision Microbiome Profiling platform (PMP) 3 weeks Feces analyses of microbiota before and after intervention with benchmark versus optimized gluten-free products.
Trial Locations
- Locations (1)
Oslo Metropolitan University
🇳🇴Oslo, Norway