Gfree - For Improved Blood Sugar and Reduced Inflammation.

Sponsor
Göteborg University
Study ID
NCT05894746
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • gluten-free — DIETARY_SUPPLEMENT
    see info in arm description
  • probiotic — DIETARY_SUPPLEMENT
    see info in arm description
  • gluten — DIETARY_SUPPLEMENT
    see info in arm description

Study Details

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.

Key Dates

First listed
Jun 8, 2023
Start date
May 4, 2023
Status verified
Oct 2024
Primary completion
Dec 1, 2025
Completion
Dec 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: gluten-free
    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.
  • Active Comparator: gluten
    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.
  • Active Comparator: probiotic
    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.

Primary Outcome Measure

Stabilizing of blood sugar levels [ Time Frame: 0 days to 4 weeks ]

Central Contacts

Find similar trials

Nationwide
Celiac disease trialsGastroenterology trialsAutoimmune disease trials

Related Studies