Glutenfree, Gut Microbiota and Metabolic Regulation

Celiac Disease Clinical Trial

— GRAIN  

Official title:

The Effect of Gluten-free Diet on Gut Microbiota and Metabolic Regulation in People With Coeliac Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135923
• Other study ID #: 20/02822
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: April 2022
• Source: Oslo Metropolitan University
• Contact: Vibeke H Telle-Hansen, PhD
• Phone: +4793048873
• Email: vtelle[@]oslomet.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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).

Locations

Country	Name	City	State
Norway	Oslo Metropolitan University	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo Metropolitan University	Det Glutenfrie Verksted, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Concentration of blood inflammatory markers	Blood analyses of inflammatory markers (fasting) before and after intervention with benchmark versus optimized gluten-free products.	3 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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