An interventional study of Randomized, controlled trial (RCT) with parallel arms and double blinded in Celiac Disease, sponsored by Oslo Metropolitan University. Completed at 1 site in Norway. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Oslo Metropolitan University · Not applicable, Interventional, and Prevention
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.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Oslo Metropolitan University is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Products containing less than 6g fibre per 100g product.
Dietary Supplement: Randomized, controlled trial (RCT) with parallel arms and double blinded
Products containing less than 6g fibre per 100g product.
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).
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.
Time frame: 3 weeks
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.
Time frame: 3 weeks
Concentration of blood inflammatory markers
Blood analyses of inflammatory markers (fasting) before and after intervention with benchmark versus optimized gluten-free products.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 3 weeks
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Oslo Metropolitan University