Status:
RECRUITING
Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity.
Lead Sponsor:
Celia Bañuls
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Obese Patients (BMI ≥ 30 kg/m²)
Anxiety
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Obese individuals are a particularly vulnerable population for mental health problems, especially depression and anxiety. The aim of this study is to evaluate whether the intake of a synbiotic, compos...
Detailed Description
Obesity is one of the most widespread chronic diseases globally, resulting from a complex interaction between dietary habits and environmental and genetic factors. According to the statistics from the...
Eligibility Criteria
Inclusion
- Patients with BMI 30-40kg/m2, with at least 5 years of diagnosed obesity evolution.
- Patients have had stable body weight (\<5% of body weight changes) during the 3 months prior to the study.
- Participants between 18 and 65 years of age.
Exclusion
- All patients with acute or chronic inflammatory diseases, neoplasic disease, secondary causes of obesity (uncontrolled hypothyroidism, Cushing's syndrome), or established liver and kidney failure (according to transaminase levels ±2 SD of the mean and estimated glomerular filtration rate using the CKD-EPI formula \>60), previous bariatric surgery, and women during pregancy or lactation, will be excluded.
- Participants who have been treated with antibiotics 3 months prior to inclusion.
- Patients with different psychiatric disorders apart from anxiety and/or depression, and also those who are already on antidepressants before the inclusion.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06901739
Start Date
April 15 2025
End Date
December 31 2027
Last Update
August 5 2025
Active Locations (1)
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1
FISABIO
Valencia, Valencia, Spain, 46020