NCT06869941Recruiting
Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis
Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis (POINSETTIA Study)
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
This study aims to understand how adipose tissue (fat) and the gut microbiota (the bacteria in the gut) may influence brain function and cognition. It has been observed that changes in adipose tissue in animals such as mice and Drosophila (a type of insect) affect memory and other brain functions. Additionally, it is believed that the gut microbiota also plays an important role in cognition. This study will explore how gene expression in adipose tissue, blood metabolites, and the gut microbiota are related to cognitive function, such as memory and thinking, in individuals with and without obesity. The investigation will also assess whether these factors can predict changes in the brain over time and how they influence sleep, physical activity, and blood sugar regulation. Advanced technologies will be used to analyze samples of tissue, blood, and microbiota, with the goal of identifying new mechanisms through which obesity affects the brain. This research may contribute to the development of new diagnostic and therapeutic strategies for cognitive problems in individuals with obesity.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 5 Mar 2025
- Start date
- Aug 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Diseases
- Obesity
- NCT number
- NCT06869941
What you commit to
- Study type: Observational
- Planned participants: 100
- From Aug 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics/antifungals/antivirals (previous 3 months).
- Chronic steroidal/anti-inflammatory drug use.
- Excessive alcohol intake, acute or chronic (\>40g/day (women), \>80g/day (men)) or drug abuse.
Other illness
- 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.
- Those with infection symptoms in the past month.
- Major psychiatric history.
- Participants with severe eating disorders.
- History of iron balance disorders (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
- 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.
Lab values
- Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
- Creatinine greater than 1.2 and glomerular filtration rate below 40.
Other
- Not meeting inclusion criteria.
- Pregnant/breastfeeding women.
- Persons under legal/administrative restrictions.
- Immunosuppressants treatment.
- Chronic constipation (bowel movement frequency ≥ 7 days) .
Who the study is looking for
- Men and women \>20 years old.
- Scheduled for surgical intervention to extract adipose tissue.
- Signed informed consent for study participation.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut d'Investigació Biomèdica de Girona (IDIBGI) Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.