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DiabetesNCT05894746

Gfree - For Improved Blood Sugar and Reduced Inflammation.

A study testing gluten-free, probiotic and gluten in people with Diabetes and Celiac Disease, run by Göteborg University at 2 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to reduce inflammation and improve glycemic control in healthy volunteers, parents, as well as children, adolescents and adults with or without diabetes. Read more about this study

Who is it for?
Ages 6 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes, Celiac Disease, Autoimmunity
What is being tested?
gluten-free, probiotic and gluten
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSweden
Study dates
4 May 2023to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • none

Who cannot join

  • A diagnosis of celiac disease

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Åsa Torinsson Naluai, PhD contact

(0046)768-979149

asa.torinsson.naluai@gu.se

Katarina Ejeskär Ejeskär, PhD contact

Katarina.Ejeskar@his.se

Sweden2 sites, 2 recruiting
  • Sahlgrenska University Hospital

    Gothenburg

    Åsa Torinsson Naluai, PhD, +46768979149, asa@clingen.gu.se

    Åsa Torinsson Naluai, PhD

    Not yet recruiting
  • University of Skövde

    Skövde

    Katarina Ejeskär, PhD, Katarina.Ejeskar@his.se

    Katarina Ejeskär, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: GFREE - A Study for Improved Blood Sugar Levels, Reduced Inflammation and for Increasing Knowledge of the Connection Between Diabetes and COVID-19.

The goal of this clinical trial is to reduce inflammation and improve glycemic control in healthy volunteers, parents, as well as children, adolescents and adults with or without diabetes. The main questions it aims to answer are: • does a reduction wheat gluten improve glycemic control and/or inflammatory biomarkers • does a reduction in certain amino acids (which is most common in wheat gluten) improve glycemic control and/or inflammatory biomarkers • can we identify individuals with an inflammatory response, which leads to poor glycemic control. Participants will eat gluten-free products as well as similar products containing gluten. They will also eat gluten together with probiotics to see if an effect of gluten can be reduced. Researchers will compare everyone with themselves (cross-over design) and if possible individuals with and without diabetes.

Read the detailed description

BACKGROUND AND PURPOSE Many diseases, which are common in high-income countries, have an inflammatory component. In the world's rich countries, about 10% of the population will be diagnosed with a traditional inflammatory autoimmune disease during their lifetime. In an autoimmune disease, the body produces auto-antibodies against the body's own protein and the immune system destroys the body's own tissues. There are hundreds of different types of autoimmune diseases where some of the most common are; celiac disease (gluten intolerance), psoriasis, type 1 diabetes (T1D), multiple sclerosis, rheumatic diseases or thyroid diseases. Diseases such as cardiovascular disease, type 2 diabetes (T2D) and Alzheimer's disease are now also considered to have inflammatory components, and so-called auto-antibodies have been identified that indicate autoimmunity also in these diseases. Autoantibodies have also been identified in COVID-19 patients.

To try to understand the biology behind autoimmunity and inflammatory disease, the investigators have analyzed the entire genome of patients with celiac disease as a model for autoimmunity. Celiac disease is a good so-called model disease for autoimmunity because the autoimmune reaction can be switched on and off with the help of gluten in the diet. With a strict gluten-free diet, virtually all signs of illness disappear and the inflammation ceases. The results from our whole genome analysis showed that genes involved in amino acid signaling were important for disease development and pointed to associations between celiac disease, T2D and anorexia. These results were somewhat surprising and the investigators began to look at the role of nutritional signaling and amino acids in inflammatory processes further.

The purpose of this study is to test whether a reduction in certain amino acids (which is most common in wheat gluten) can improve glycemic control in healthy volunteers, parents, as well as children, adolescents and adults with diabetes and whether levels of inflammatory amino acids may be one of the factors behind the link between diabetes and severe COVID-19 infection.

The participants will, for 4 weeks, eat one week as usual, eat one week wheat gluten-free, one week wheat gluten and one week with gluten and probiotics. The participants will be provided with continuous glucose monitors and activity-tracking bracelets. The investigators will analyze the efficiency of glucose uptake using continuous glucose monitors (CGM). During these four weeks, the research subjects will be admitted for 4 clinical visits (baseline, after 1 week, 2 weeks, 3 weeks) where blood samples will be taken. Also, during these weeks the participant will take capillary blood samples, faeces, urine, buccal swabs and saliva at home and fill out a questionnaire based on diet and risk factors for diabetes and questions about COVID-19.

Total number of participants: 60 Sampling occasions per participant: 15 Follow-up period per participant: 4 weeks Number of years for inclusion: 2 years (20221201-20241201)

Being tested
gluten-free, probiotic, gluten
Keywords
gluten, probiotics, diet
Medical subject headings
Diabetes Mellitus, Celiac Disease, Autoimmune Diseases, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gluten-freeDietary supplement

    see info in arm description

  • probioticDietary supplement

    see info in arm description

  • glutenDietary supplement

    see info in arm description

Study groups in NCT05894746
Study groupRoleWhat they receive
gluten-freeExperimentalThe study participants will start the gluten-free diet and be asked to exchange any products they normally buy with similar products. Three days in the week they will eat a meal with gluten free pasta. Two to six hours after the meal they will take samples at home and store until they return to the clinic.
Receives: Dietary Supplement: gluten-free
glutenActive comparatorThe study participants will continue the gluten-free diet and be asked to exchange any products they normally buy with similar products. Three days however, in the week they will eat a meal with regular gluten containing pasta. Two to six hours after the meal they will take samples at home and store until they return to the clinic.
Receives: Dietary Supplement: gluten-free; Dietary Supplement: gluten
probioticActive comparatorThe study participants will continue the gluten-free diet and be asked to exchange any products they normally buy with similar products. During the week they will also take probiotic (Probion, Active) every morning and every evening. Three days however, in the week they will eat a meal with regular gluten containing pasta. Two to six hours after the meal they will take samples at home and store until they return to the clinic.
Receives: Dietary Supplement: gluten-free; Dietary Supplement: probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stabilizing of blood sugar levels

    Continuous glucose monitoring (CGM) data will be analysed together with activity level data, lower glucose peaks after a meal, adjusted for activity level.

    Measured: 0 days to 4 weeks

  2. Amino acid metabolism

    Lowering of the aminoacid proline

    Measured: 0 days to 4 weeks

Secondary outcomes (3)
  1. Blood Lipids

    LDL, improved apolipoprotein B (APOB)

    Measured: 0 days to 4 weeks

  2. Glutathione S Transferases

    Relative Glutathione S Transferases expression levels

    Measured: 0 days to 4 weeks

  3. Fibrinogen

    Relative Fibrinogen expression levels

    Measured: 0 days to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2023
  2. Study start4 May 2023
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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
Non-randomised
Intervention model
Crossover
Model description
Four week crossover trial with three arms, gluten-free, gluten and gluten with probiotic
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05894746
Sponsor's protocol ID
GFREE
Status last verified
Oct 2024
First submitted
5 May 2023
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan at the moment but the aim is to share data as much as possible.

Questions about this trial

What is this clinical trial studying?

A study testing gluten-free, probiotic and gluten in people with Diabetes and Celiac Disease, run by Göteborg University at 2 sites in Sweden.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Åsa Torinsson Naluai, PhD ((0046)768-979149, asa.torinsson.naluai@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stabilizing of blood sugar levels (time frame: 0 days to 4 weeks). The study lists 2 primary outcomes in all. 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 15 Oct 2024.

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