Study of Synbiotic Supplement Effects on Gut Health and Mental Well-being in Adults With Obesity and Anxiety or Depression

What this Trial Is About

Researchers are exploring the potential benefits of a synbiotic supplement, combining prebiotics and beneficial bacteria, for adults with obesity who may also experience anxiety or depression. The study aims to see if this supplement can change the gut microbiota and improve metabolic, inflammatory, intestinal, and appetite-related functions, along with mood and quality of life. It is a randomized, double-blind, placebo-controlled study involving 120 adults aged 18 to 65 with a BMI between 30 and 40, some with and some without psychological disorders, to better understand the gut-brain connection in obesity and mental health. Participants will be divided into groups receiving either the synbiotic supplement or a placebo daily for 12 weeks, alongside personalized nutritional counseling from a registered dietitian. The synbiotic contains specific strains of Lactobacillus and Bifidobacterium bacteria combined with tannin-based compounds. Both groups will follow a tailored hypocaloric diet, and psychological and nutritional follow-up assessments will be conducted throughout the study. Biological samples, including blood, saliva, urine, and stool, will be collected before and after the intervention for detailed analysis. During the study, participants will undergo body composition measurements, dietary and physical activity assessments, and psychological evaluations using standardized questionnaires. Researchers will measure numerous biochemical markers related to inflammation, antioxidant capacity, gut function, neurotransmitter levels, and the diversity and metabolic activity of the gut microbiota. Advanced techniques like gene expression analysis and organ-on-chip models will be used to study the gut-brain axis mechanisms. The study will last three years, focusing on microbiota diversity and mental health improvements as primary outcomes.

Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity.