Exploring how gut bacteria and the brain interact in obesity

Involvement of the Gut Microbiota-brain Cross-talk in the Loss of Eating Control (GMBCrossTalkFood)

This study looks at how gut bacteria and brain function work together in people with obesity to see if it affects their eating habits and metabolism.

Quick facts

• Study type: Observational
• Enrollment: 116 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Academic / other)
• Locations: 1 site (Girona, Girona)
• Trial ID: NCT05646901 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between gut microbiota and brain function in individuals with obesity. It aims to understand how these interactions may contribute to the loss of eating control and metabolic imbalances. By comparing a cohort of 100 participants, half with obesity and half without, the study will assess food addiction parameters, metabolic profiles, and brain connectivity using fMRI. Additionally, circulating microRNAs will be analyzed to explore their role as mediators in this gut-brain communication.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 30-65 years, with a BMI of 30 kg/m² or higher for those with obesity.

Not a fit: Patients with serious systemic diseases, major psychiatric disorders, or those currently on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into new therapeutic targets for obesity management by understanding the gut-brain axis.

How similar studies have performed: While the gut-brain axis is a growing area of research, this specific approach focusing on microRNAs and their role in obesity is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Men and women aged 30-65 years.
2. Informed consent for participation in the study.

Exclusion Criteria:

1. Serious systemic disease unrelated to obesity such as cancer, severe kidney, or liver disease, known as type 1 or type 2 diabetes.
2. Systemic diseases with intrinsic inflammatory activity such as rheumatoid arthritis, Crohn's disease, asthma, chronic infection (e.g., HIV, active tuberculosis), or any type of infectious disease.
3. Pregnancy and lactation.
4. Patients with severe disorders of eating behavior.
5. Persons whose liberty is under the legal or administrative requirement.
6. Clinical symptoms and signs of infection in the previous month.
7. Antibiotic, antifungal or antiviral treatment in the previous 3 months.
8. Anti-inflammatory chronic treatment with steroidal and/or non-steroidal anti-inflammatory drugs.
9. Major psychiatric antecedents.
10. Excessive alcohol intake, either acute or chronic (alcohol intake greater than 40 g a day (women) or 80 g/day (men)) or drug abuse.
11. Serum liver enzyme (AST, ALT) activity over twice the upper limit of normal.
12. History of disturbances in iron balance (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
13. Creatinine greater than 1.2 and glomerular filtration rate less than 40.
14. Immunosuppressants treatment.
15. Chronic constipation (depositional habit ≥ 7 days)
16. Kidney failure, history of a kidney transplant, or current treatment with dialysis.
17. Treatment with a slimming product during the previous two months.
18. Class III or IV heart failure (according to the New York Heart Association), medical records of ischemic cardiovascular disease.
19. Current treatment for malignant neoplasm.

Where this trial is running

Girona, Girona

• Institut d'Investigació Biomèdica de Girona (IDIBGI) — Girona, Girona, Spain (Recruiting)

Study contacts

• Principal investigator: José Manuel Fernández-Real, M.D., Ph.D. — Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Study coordinator: José Manuel Fernández-Real, M.D., Ph.D.

Conditions Obesity; Continous Glucose Monitoring; Cognition; Brain Iron content; microRNA