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Glutenfree, Gut Microbiota and Metabolic Regulation (GRAIN)

Primary Purpose

Celiac Disease

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Randomized, controlled trial (RCT) with parallel arms and double blinded
Sponsored by
Oslo Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Celiac Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Oslo Metropolitan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Benchmark gluten-free products

Optimised gluten-free products

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Concentration of blood inflammatory markers
Blood analyses of inflammatory markers (fasting) before and after intervention with benchmark versus optimized gluten-free products.
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.
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)
Concentration of satiety hormones in blood
Blood analyses of satiety hormones (fasting) before and after intervention with benchmark versus optimized gluten-free products.
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).

Full Information

First Posted
October 12, 2021
Last Updated
April 18, 2022
Sponsor
Oslo Metropolitan University
Collaborators
University of Oslo, Det Glutenfrie Verksted
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1. Study Identification

Unique Protocol Identification Number
NCT05135923
Brief Title
Glutenfree, Gut Microbiota and Metabolic Regulation
Acronym
GRAIN
Official Title
The Effect of Gluten-free Diet on Gut Microbiota and Metabolic Regulation in People With Coeliac Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo Metropolitan University
Collaborators
University of Oslo, Det Glutenfrie Verksted

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Benchmark gluten-free products
Arm Type
Active Comparator
Arm Description
Products containing less than 6g fibre per 100g product.
Arm Title
Optimised gluten-free products
Arm Type
Experimental
Arm Description
Products containing less than 6g fibre per 100g product.
Intervention Type
Dietary Supplement
Intervention Name(s)
Randomized, controlled trial (RCT) with parallel arms and double blinded
Intervention Description
Experiment group receive optimized gluten free products (high in fiber and whole grain) compared to comparable benchmark gluten free products (control group).
Primary Outcome Measure Information:
Title
Concentration of blood glucose
Description
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 Outcome Measure Information:
Title
Concentration of blood cholesterol, triglycerides, fatty acids, C-peptide
Description
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
Title
Concentration of blood inflammatory markers
Description
Blood analyses of inflammatory markers (fasting) before and after intervention with benchmark versus optimized gluten-free products.
Time Frame
3 weeks
Title
Feces microbiota analyses performed with Bio-Me's Precision Microbiome Profiling platform (PMP)
Description
Feces analyses of microbiota before and after intervention with benchmark versus optimized gluten-free products.
Time Frame
3 weeks
Title
Gastrointestinal Symptoms Rating Scale-Irritable bowl syndrome (GSRS-IBS)
Description
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
Title
Concentration of satiety hormones in blood
Description
Blood analyses of satiety hormones (fasting) before and after intervention with benchmark versus optimized gluten-free products.
Time Frame
3 weeks
Title
Bristol Stool Chart (BSC)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vibeke H Telle-Hansen, PhD
Phone
+4793048873
Email
vtelle@oslomet.no
First Name & Middle Initial & Last Name or Official Title & Degree
Mari Myhrstad, PhD
Phone
+4791392176
Email
mmyhrsta@oslomet.no
Facility Information:
Facility Name
Oslo Metropolitan University
City
Oslo
ZIP/Postal Code
0130
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vibeke Telle-Hansen, PhD
Phone
47 67 23 68 19
Email
vtelle@oslomet.no
First Name & Middle Initial & Last Name & Degree
Vibeke Telle-Hansen, PhD

12. IPD Sharing Statement

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Glutenfree, Gut Microbiota and Metabolic Regulation

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