Gfree - For Improved Blood Sugar and Reduced Inflammation.

NCT05894746 | Recruiting

• 1 other identifier: GFREE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes; Celiac Disease; Autoimmunity; Metabolic Disease

Keywords

gluten; probiotics; diet

Outcome Measures

Primary Outcomes (2)

• 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.

  0 days to 4 weeks

• Amino acid metabolism

  Lowering of the aminoacid proline

  0 days to 4 weeks

Secondary Outcomes (3)

• Blood Lipids

  0 days to 4 weeks

• Glutathione S Transferases

  0 days to 4 weeks

• Fibrinogen

  0 days to 4 weeks

Other Outcomes (1)

• multiomics explorative analyses

  0 days to 4 weeks

Study Arms (3)

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.

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.

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.

Dietary Supplement: gluten-free; Dietary Supplement: probiotic

Interventions

gluten-free DIETARY_SUPPLEMENT

see info in arm description

gluten; gluten-free; probiotic

probiotic DIETARY_SUPPLEMENT

see info in arm description

probiotic

gluten DIETARY_SUPPLEMENT

see info in arm description

gluten

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- none

You may not qualify if:

• \- A diagnosis of celiac disease

Sponsors & Collaborators

• Göteborg University: lead
• University of Skövde: collaborator
• Sahlgrenska University Hospital: collaborator
• Ekhaga foundation: collaborator

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, Sweden

NOT YET RECRUITING

University of Skövde

Skövde, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Celiac Disease; Autoimmune Diseases; Metabolic Diseases

Interventions

Diet, Gluten-Free; Probiotics; Glutens

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food; Food and Beverages; Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Åsa Torinsson Naluai, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

• Katarina Ejeskär, PhD

  University of Skövde

  STUDY DIRECTOR

Central Study Contacts

Åsa Torinsson Naluai, PhD

CONTACT

(0046)768-979149; asa.torinsson.naluai@gu.se

Katarina Ejeskär Ejeskär, PhD

CONTACT

Katarina.Ejeskar@his.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four week crossover trial with three arms, gluten-free, gluten and gluten with probiotic

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 8, 2023
• Study Start: May 4, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)