Improving blood sugar and reducing inflammation through diet changes.
GFREE - A Study for Improved Blood Sugar Levels, Reduced Inflammation and for Increasing Knowledge of the Connection Between Diabetes and COVID-19.
This study is testing whether a gluten-free diet and probiotics can help improve blood sugar levels and reduce inflammation in healthy people, including those with and without diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Göteborg University Academic / other |
| Locations | 2 sites (Gothenburg and 1 other locations) |
| Trial ID | NCT05894746 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the effects of a gluten-free diet and probiotics on glycemic control and inflammation in healthy volunteers, including children, adolescents, and adults with or without diabetes. Participants will consume both gluten-free products and gluten-containing products, as well as gluten with probiotics, to assess their impact on inflammatory biomarkers and glycemic control. The study employs a cross-over design, allowing researchers to compare the effects within individuals over time. The goal is to identify individuals who may have an inflammatory response affecting their glycemic control.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals, parents, and children or adults with or without diabetes who are interested in dietary interventions.
Not a fit: Patients diagnosed with celiac disease will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that improve blood sugar management and reduce inflammation for individuals at risk of diabetes and autoimmune diseases.
How similar studies have performed: Other studies have shown promising results in dietary interventions for managing inflammation and glycemic control, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- none Exclusion Criteria: \- A diagnosis of celiac disease
Where this trial is running
Gothenburg and 1 other locations
- Sahlgrenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)
- University of Skövde — Skövde, Sweden (Recruiting)
Study contacts
- Principal investigator: Åsa Torinsson Naluai, PhD — Göteborg University
- Study coordinator: Åsa Torinsson Naluai, PhD
- Email: asa.torinsson.naluai@gu.se
- Phone: (0046)768-979149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.