search
Back to results

Gfree - For Improved Blood Sugar and Reduced Inflammation.

Primary Purpose

Diabetes, Celiac Disease, Autoimmunity

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
gluten-free
probiotic
gluten
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring gluten, probiotics, diet

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - none Exclusion Criteria: - A diagnosis of celiac disease

Sites / Locations

  • Sahlgrenska University Hospital
  • University of SkövdeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

gluten-free

gluten

probiotic

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
Amino acid metabolism
Lowering of the aminoacid proline

Secondary Outcome Measures

Blood Lipids
LDL, improved apolipoprotein B (APOB)
Glutathione S Transferases
Relative Glutathione S Transferases expression levels
Fibrinogen
Relative Fibrinogen expression levels

Full Information

First Posted
May 5, 2023
Last Updated
June 7, 2023
Sponsor
Göteborg University
Collaborators
University of Skövde, Sahlgrenska University Hospital, Sweden, Ekhaga foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT05894746
Brief Title
Gfree - For Improved Blood Sugar and Reduced Inflammation.
Official Title
GFREE - A Study for Improved Blood Sugar Levels, Reduced Inflammation and for Increasing Knowledge of the Connection Between Diabetes and COVID-19.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
University of Skövde, Sahlgrenska University Hospital, Sweden, Ekhaga foundation

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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Celiac Disease, Autoimmunity, Metabolic Disease
Keywords
gluten, probiotics, diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Four week crossover trial with three arms, gluten-free, gluten and gluten with probiotic
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gluten-free
Arm Type
Experimental
Arm Description
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.
Arm Title
gluten
Arm Type
Active Comparator
Arm Description
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.
Arm Title
probiotic
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
gluten-free
Intervention Description
see info in arm description
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic
Intervention Description
see info in arm description
Intervention Type
Dietary Supplement
Intervention Name(s)
gluten
Intervention Description
see info in arm description
Primary Outcome Measure Information:
Title
Stabilizing of blood sugar levels
Description
Continuous glucose monitoring (CGM) data will be analysed together with activity level data, lower glucose peaks after a meal, adjusted for activity level.
Time Frame
0 days to 4 weeks
Title
Amino acid metabolism
Description
Lowering of the aminoacid proline
Time Frame
0 days to 4 weeks
Secondary Outcome Measure Information:
Title
Blood Lipids
Description
LDL, improved apolipoprotein B (APOB)
Time Frame
0 days to 4 weeks
Title
Glutathione S Transferases
Description
Relative Glutathione S Transferases expression levels
Time Frame
0 days to 4 weeks
Title
Fibrinogen
Description
Relative Fibrinogen expression levels
Time Frame
0 days to 4 weeks
Other Pre-specified Outcome Measures:
Title
multiomics explorative analyses
Description
Genomics, transcriptomics2, metabolomics and proteomics analyses are planned
Time Frame
0 days to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - none Exclusion Criteria: - A diagnosis of celiac disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Åsa Torinsson Naluai, PhD
Phone
+46768979149
Email
asa.torinsson.naluai@gu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Katarina Ejeskär Ejeskär, PhD
Email
Katarina.Ejeskar@his.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Åsa Torinsson Naluai, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katarina Ejeskär, PhD
Organizational Affiliation
University of Skövde
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Åsa Torinsson Naluai, PhD
Phone
+46768979149
Email
asa@clingen.gu.se
First Name & Middle Initial & Last Name & Degree
Åsa Torinsson Naluai, PhD
Facility Name
University of Skövde
City
Skövde
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarina Ejeskär, PhD
Email
Katarina.Ejeskar@his.se
First Name & Middle Initial & Last Name & Degree
Katarina Ejeskär, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan at the moment but the aim is to share data as much as possible.

Learn more about this trial

Gfree - For Improved Blood Sugar and Reduced Inflammation.

We'll reach out to this number within 24 hrs