Exploring how gut bacteria and the brain interact in obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: jmfreal@idibgi.org
• Phone: +34 972 94 02 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.