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.
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.
Katarina Ejeskär Ejeskär, PhD contact
Sweden2 sites, 2 recruiting
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg
Åsa Torinsson Naluai, PhD, +46768979149, asa@clingen.gu.se
Åsa Torinsson Naluai, PhD
- Recruiting
University of Skövde
Skövde
Katarina Ejeskär, PhD, Katarina.Ejeskar@his.se
Katarina Ejeskär, PhD
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)
- Conditions
- Diabetes, Celiac Disease, Autoimmunity, Metabolic Disease
- 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 group | Role | What they receive |
|---|---|---|
| gluten-free | Experimental | The 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 |
| gluten | Active comparator | The 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 |
| probiotic | Active comparator | The 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.
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
Amino acid metabolism
Lowering of the aminoacid proline
Measured: 0 days to 4 weeks
Secondary outcomes (3)
Blood Lipids
LDL, improved apolipoprotein B (APOB)
Measured: 0 days to 4 weeks
Glutathione S Transferases
Relative Glutathione S Transferases expression levels
Measured: 0 days to 4 weeks
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.
- First posted8 Jun 2023
- Study start4 May 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Skövde, Sahlgrenska University Hospital, Ekhaga foundation
- Responsible party
- Sponsor
- Investigators
- Åsa Torinsson Naluai, PhD, Principal investigator, Göteborg UniversityKatarina Ejeskär, PhD, Study director, University of Skövde
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GFREE - A Study for Improved Blood Sugar Levels, Reduced Inflammation and for Increasing Knowledge of the Connection Between Diabetes and COVID-19.
- ClinicalTrials.gov ID
- NCT05894746
- Acronym / sponsor ID
- GFREE
- Conditions
- Diabetes, Celiac Disease, Autoimmunity, Metabolic Disease
- Keywords
- gluten, probiotics, diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- University of Skövde, Sahlgrenska University Hospital, Ekhaga foundation
- Study start
- 4 May 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Jun 2023 (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.
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.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Four week crossover trial with three arms, gluten-free, gluten and gluten with probiotic
| Arm | Type | Receives |
|---|---|---|
| gluten-free | Experimental | Dietary Supplement: gluten-freeThe 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. |
| gluten | Active comparator | Dietary Supplement: gluten-free, Dietary Supplement: glutenThe 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. |
| probiotic | Active comparator | Dietary Supplement: gluten-free, Dietary Supplement: probioticThe 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- none
Key exclusion criteria (1 listed)
- A diagnosis of celiac disease
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 |
|---|---|---|
| gluten-freesee info in arm description | Dietary supplement | gluten, gluten-free, probiotic |
| probioticsee info in arm description | Dietary supplement | probiotic |
| glutensee info in arm description | Dietary supplement | gluten |
Primary outcome
Stabilizing of blood sugar levels
Time frame: 0 days to 4 weeks
Continuous glucose monitoring (CGM) data will be analysed together with activity level data, lower glucose peaks after a meal, adjusted for activity level.
Amino acid metabolism
Time frame: 0 days to 4 weeks
Lowering of the aminoacid proline
3 secondary outcomes
Blood Lipids
Time frame: 0 days to 4 weeks
Glutathione S Transferases
Time frame: 0 days to 4 weeks
Fibrinogen
Time frame: 0 days to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No. No plan at the moment but the aim is to share data as much as possible.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Katarina Ejeskär Ejeskär, PhD contact
Åsa Torinsson Naluai, PhD principal investigator
Göteborg University
Katarina Ejeskär, PhD study director
University of Skövde
2 sites in 1 country: see every site and its status.
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.