Understanding how fat and gut bacteria affect brain function and cognition

Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis (POINSETTIA Study)

This study looks at how fat and gut bacteria affect brain function and thinking in people with and without obesity.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (other)
• Locations: 1 site (Girona, Girona)
• Trial ID: NCT06869941 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between adipose tissue gene expression, blood metabolites, and gut microbiota in relation to cognitive function in individuals with and without obesity. It aims to explore how these factors influence memory, thinking, sleep, physical activity, and blood sugar regulation. Advanced technologies will be employed to analyze samples from participants scheduled for surgical extraction of adipose tissue, with the goal of identifying mechanisms through which obesity may impact brain function over time.

Who should consider this trial

Good fit: Ideal candidates are men and women over 20 years old who are scheduled for surgical intervention to extract adipose tissue.

Not a fit: Patients with non-obesity-related systemic diseases or significant psychiatric history may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new insights into how obesity affects cognitive function, potentially guiding future interventions.

How similar studies have performed: While the specific approach of linking adipose tissue and gut microbiota to cognition is novel, related studies have shown promising results in understanding the gut-brain axis.

Eligibility criteria

Inclusion Criteria:

* Men and women \>20 years old.
* Scheduled for surgical intervention to extract adipose tissue.
* Signed informed consent for study participation.

Exclusion Criteria:

* Not meeting inclusion criteria.
* Non-obesity-related systemic diseases (cancer, severe kidney/liver disease).
* Systemic diseases with intrinsic inflammation (rheumatoid arthritis, Crohn's disease, asthma, chronic infections (HIV/tuberculosis)) or any type of infectious disease.
* Pregnant/breastfeeding women.
* Persons under legal/administrative restrictions.
* Those with infection symptoms in the past month.
* Use of antibiotics/antifungals/antivirals (previous 3 months).
* Chronic steroidal/anti-inflammatory drug use.
* Major psychiatric history.
* Excessive alcohol intake, acute or chronic (\>40g/day (women), \>80g/day (men)) or drug abuse.
* Immunosuppressants treatment.
* Participants with severe eating disorders.
* Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
* History of iron balance disorders (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
* Creatinine greater than 1.2 and glomerular filtration rate below 40.
* Current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer.
* Heart disease classified as class III or IV, known ischemic cardiovascular disease.
* Renal failure, history of kidney transplant, or current dialysis treatment.
* Chronic constipation (bowel movement frequency ≥ 7 days) .

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, Gut-microbiota-brain axis