Glutenfree, Gut Microbiota and Metabolic Regulation

Oslo Metropolitan University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Celiac Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Glutenfree, Gut Microbiota and Metabolic Regulation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes