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

Launched by INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE GIRONA DR. JOSEP TRUETA · Dec 2, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how the gut microbiota, which is the collection of bacteria in our intestines, interacts with the brain and affects our control over eating, particularly in people who are overweight or obese. Researchers believe that this communication might play a key role in why some individuals struggle to manage their food intake. They will study the relationship between gut bacteria, certain small molecules called microRNAs that influence gene activity, and how these factors may impact a person's metabolism and behavior related to eating.

To participate in this study, individuals must be between 30 and 65 years old and provide informed consent. Those with serious health issues unrelated to obesity, certain systemic diseases, or those experiencing severe eating disorders will not be eligible. Participants will complete questionnaires about their eating habits and undergo brain imaging to assess how their brain connects while considering food. Additionally, researchers will analyze the gut bacteria and microRNAs in the participants' blood to better understand their roles in eating behavior and weight management. If you're considering joining, this study aims to uncover important insights that could help improve treatments for obesity in the future.

Gender

ALL

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.

Trial Officials