Glutenfree, Gut Microbiota and Metabolic Regulation

NCT05135923 | Completed

• 1 other identifier: 20/02822
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Concentration of blood cholesterol, triglycerides, fatty acids, C-peptide

  3 weeks

• Concentration of blood inflammatory markers

  3 weeks

• Feces microbiota analyses performed with Bio-Me's Precision Microbiome Profiling platform (PMP)

  3 weeks

• Gastrointestinal Symptoms Rating Scale-Irritable bowl syndrome (GSRS-IBS)

  3 weeks

• Concentration of satiety hormones in blood

  3 weeks

Study Arms (2)

Benchmark gluten-free products

ACTIVE COMPARATOR

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

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

Optimised gluten-free products

EXPERIMENTAL

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

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

Interventions

Randomized, controlled trial (RCT) with parallel arms and double blinded DIETARY_SUPPLEMENT

Experiment group receive optimized gluten free products (high in fiber and whole grain) compared to comparable benchmark gluten free products (control group).

Benchmark gluten-free products; Optimised gluten-free products

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals with celiac disease
• BMI 18.5-27
• years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• University of Oslo: collaborator
• Det Glutenfrie Verksted: collaborator

Study Sites (1)

Oslo Metropolitan University

Oslo, 0130, Norway

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Random Allocation; Double-Blind Method

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 26, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

NO (1)