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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Det Glutenfrie Verksted | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benchmark gluten-free products | Active Comparator | Products containing less than 6g fibre per 100g product. |
|
| Optimised gluten-free products | Experimental | Products containing less than 6g fibre per 100g product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo Metropolitan University | Oslo | 0130 | Norway |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011897 | Random Allocation |
| D004311 | Double-Blind Method |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008722 | Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |