New Dietary Intervention Strategies on the Intestinal Microbiota to Improve Mental Health Subjects With Obesity: Therapeutic Potential of a Synbiotic.

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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, composed of prebiotics and beneficial intestinal bacterial strains, is capable of producing changes in the gut microbiota and its functionality, improving metabolic and inflammatory parameters, intestinal function and appetite control in patients with obesity and psychological disorders. In addition, the production of neurotransmitters at the level of the gut-brain axis will be studied, as well as mood and quality of life. For this purpose, a prospective, randomized, doubleblind, placebo-controlled intervention study will be carried out in patients with obesity (BMI=30-40 kg/m2) and symptoms of anxiety and/or depression, or patients with obesity but without these psychological disorders (n=120). The groups will be randomly divided into two groups (n=60) according to the intake of a synbiotic (1 capsule/day composed of bifidobacterium, Lactobacillus and tannin-based phytocomplexes) or its corresponding placebo for 12 weeks. Individualized psychological and nutritional follow-up will be carried out, demographic, lifestyle and mental health variables will be collected, and biological samples will be collected before and after the intervention. In addition, all patients will undergo an assessment of body composition and nutritional status, together with cardiovascular risk factors and comorbidities (hypertension, dyslipidemia, DM2, insulin resistance). Inflammatory parameters (IL6, TNF , IL1b, adiponectin, PAI-1, IL10, resistin, adipsin), antioxidant capacity, intestinal function (zonulin, LPS, occludin, LBP, FABP2/I-FABP, -glucan, Reg3A), satiety, appetite control (Leptin, GLP1, GIP, Ghrelin, PP) and neurotransmitter production (cortisol, dopamine, serotonin, oxytocin) in plasma/serum, urine or saliva using ELISA Kits and Luminex XMAP technology will be analyzed. In addiition, the investigators will perform analysis of genetic markers of inflammatory and metabolic pathways (Nanostring technology), metabolomic profiling (NMR spectroscopy and PLS-DA) in plasma, and both content and diversity of the intestinal microbiota (16S rRNA amplicons, and direct metagenomic sequencing, with Illumina MiSeq technology) in faeces will be evaluated. Finally, the investigators will study in vitro the mechanism of action of colonic digest on complex cellular models that simulate the gut-brain axis (organ-on-chip model, OoC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
FISABIO
RECRUITING
Valencia
Contact Information
Primary
Celia Bañuls Morant, PhD
celia.banuls@fisabio.es
963188882
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Synbiotic supplement in subjects with obesity and mental disorders
Subjects with both obesity and mental disorders (only including anxiety or depression diagnosed disorders) will recieve the synbiotic supplement and nutritional intervention by a registered dietitian for 12 weeks.
Active_comparator: Synbiotic supplement in subjects with obesity and without mental disorders
Subjects with obesity yet without diagnosed mental disorders will recieve the synbiotic supplement and nutritional intervention by a registered dietitian for 12 weeks.
Placebo_comparator: Placebo in subjects with obesity and mental disorders
Subjects with both obesity and mental disorders will recieve nutritional intervention by a registered dietitian and a supplement containing a powder with an identical color compared to the synbiotic supplement.
Placebo_comparator: Placebo in subjects with obesity and without mental disorders
Subjects with both obesity but no diagnosed mental disorders will recieve nutritional intervention by a registered dietitian and a supplement containing a powder with an identical color compared to the synbiotic supplement.
Related Therapeutic Areas
Sponsors
Collaborators: Instituto de Salud Carlos III
Leads: Celia Bañuls

This content was sourced from clinicaltrials.gov