Glutenfree, Gut Microbiota and Metabolic Regulation (GRAIN)

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

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 Overview

• Status: Completed
• Conditions: Celiac Disease
• Intervention / Treatment: Dietary supplement: Randomized, controlled trial (RCT) with parallel arms and double blinded

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0130
    • Oslo Metropolitan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Benchmark gluten-free products; 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).
Experimental: Optimised gluten-free products; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Collaborators: University of Oslo; Det Glutenfrie Verksted

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: 20/02822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No