Glutenfree, Gut Microbiota and Metabolic Regulation (GRAIN)

Oslo Metropolitan University

Status: Completed

Conditions: Celiac Disease

Treatments: Dietary Supplement: Randomized, controlled trial (RCT) with parallel arms and double blinded

Study type: Interventional

Funder types: Other

Identifiers

NCT05135923

20/02822

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Benchmark gluten-free products

Active Comparator group

Description:

Products containing less than 6g fibre per 100g product.

Treatment:

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

Optimised gluten-free products

Experimental group

Description:

Products containing less than 6g fibre per 100g product.

Treatment:

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