Celiac DiseaseGRAINNCT05135923
Glutenfree, Gut Microbiota and Metabolic Regulation
A study of Celiac Disease, run by Oslo Metropolitan University at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals with celiac disease
- BMI 18.5-27
- 18-65 years
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Celiac Disease
- Being tested
- Randomized, controlled trial (RCT) with parallel arms and double blinded
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized, controlled trial (RCT) with parallel arms and double blindedDietary supplement
Experiment group receive optimized gluten free products (high in fiber and whole grain) compared to comparable benchmark gluten free products (control group).
| Study group | Role | What they receive |
|---|---|---|
| Benchmark gluten-free products | Active comparator | Products containing less than 6g fibre per 100g product. Receives: 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. Receives: Dietary Supplement: Randomized, controlled trial (RCT) with parallel arms and double blinded |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (6)
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.
Measured: 3 weeks
Concentration of blood inflammatory markers
Blood analyses of inflammatory markers (fasting) before and after intervention with benchmark versus optimized gluten-free products.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Det Glutenfrie Verksted
- Responsible party
- Principal investigator, Vibeke Telle-Hansen, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135923
- Sponsor's protocol ID
- 20/02822
- Acronym
- GRAIN
- Status last verified
- Aug 2024
- First submitted
- 12 Oct 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gluten-free Diet on Gut Microbiota and Metabolic Regulation in People With Coeliac Disease
- ClinicalTrials.gov ID
- NCT05135923
- Acronym / sponsor ID
- GRAIN / 20/02822
- Conditions
- Celiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of Oslo, Det Glutenfrie Verksted
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benchmark gluten-free products | Active comparator | Dietary Supplement: Randomized, controlled trial (RCT) with parallel arms and double blindedProducts containing less than 6g fibre per 100g product. |
| Optimised gluten-free products | Experimental | Dietary Supplement: Randomized, controlled trial (RCT) with parallel arms and double blindedProducts containing less than 6g fibre per 100g product. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy individuals with celiac disease
- BMI 18.5-27
- 18-65 years
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomized, controlled trial (RCT) with parallel arms and double blindedExperiment group receive optimized gluten free products (high in fiber and whole grain) compared to comparable benchmark gluten free products (control group). | Dietary supplement | Benchmark gluten-free products, Optimised gluten-free products |
Primary outcome
Concentration of blood glucose
Time frame: 3 weeks
Blood analyses of glucose (fasting and post-prandial (after an OGTT)) before and after intervention with benchmark versus optimized gluten-free products.
6 secondary outcomes
Concentration of blood cholesterol, triglycerides, fatty acids, C-peptide
Time frame: 3 weeks
Concentration of blood inflammatory markers
Time frame: 3 weeks
Feces microbiota analyses performed with Bio-Me's Precision Microbiome Profiling platform (PMP)
Time frame: 3 weeks
Gastrointestinal Symptoms Rating Scale-Irritable bowl syndrome (GSRS-IBS)
Time frame: 3 weeks
Concentration of satiety hormones in blood
Time frame: 3 weeks
Bristol Stool Chart (BSC)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Celiac Disease, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of blood glucose (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.