Synbiotic supplement to improve mood and gut health in adults with obesity
New Dietary Intervention Strategies on the Intestinal Microbiota to Improve Mental Health Subjects With Obesity: Therapeutic Potential of a Synbiotic.
This study will test whether taking a daily synbiotic (prebiotics plus beneficial bacteria) helps mood, gut microbiota, inflammation, appetite, and metabolic markers in adults with obesity who do or do not have anxiety or depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06901739 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, double-blind, placebo-controlled intervention enrolling 120 adults with BMI 30–40 kg/m2 (age 18–65). Participants will be randomly assigned (60 per group) to receive either a synbiotic supplement or a matched placebo. The trial will measure changes in gut microbiota composition and function, neurotransmitter production related to the gut–brain axis, inflammatory and metabolic biomarkers, intestinal function, appetite control, mood, and quality of life. Key exclusions include acute or chronic inflammatory or neoplastic disease, significant liver or kidney failure, recent antibiotic use, psychiatric disorders other than anxiety/depression, current antidepressant therapy, pregnancy, lactation, or prior bariatric surgery.
Who should consider this trial
Good fit: Adults 18–65 years old with BMI 30–40 kg/m2, at least five years since obesity diagnosis, stable weight for the prior three months, and without excluded medical or psychiatric conditions are the intended participants.
Not a fit: People with active inflammatory or neoplastic disease, uncontrolled secondary causes of obesity, significant liver or kidney failure, recent antibiotic use, psychiatric disorders beyond anxiety/depression, current antidepressant use, pregnancy, lactation, or prior bariatric surgery were excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the synbiotic could provide a low-risk adjunct treatment to improve mood, gut bacterial balance, inflammation, and metabolic health in people with obesity.
How similar studies have performed: Previous small trials of probiotics and synbiotics have produced mixed but sometimes promising effects on mood and metabolic outcomes, so this approach has preliminary support but is not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Valencia, Valencia
- Fisabio — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Celia Bañuls Morant, PhD
- Email: celia.banuls@fisabio.es
- Phone: 963188882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.