Clinical trial
Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity.
Recruiting now · Not applicable · 1 countries · Registry ID NCT06901739
What this study is about
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).
Basic eligibility
Full registry criteria
Treatments and study arms
Synbiotic
The synbiotic supplement contains both tannins (350mg) and probiotic strains (Lactobacillus acidophilus, Lactobacillus casei, y Bifidobacterium lactis 2×10 9 UFC/g each) that have already demonstrated a positive health effect in obesity. Besides, participants will follow a dietary intervention to improve their dietary habits and reduce weight by a registered dietitian.
Placebo
Subjects will recieve a placebo supplement, contained in an identical capsule form as the synbiotic, along with the same dietary intervention to improve their dietary habits and reduce weight by a registered dietitian.
Primary outcomes
To assess the alpha-diversity of the intestinal microbiota after the symbiotic intake, defined as the average diversity of species in an ecosystem, the Shannon index will be used. The results are interpreted as follows: values less than 2 are considered low in diversity and values greater than 3 are high in species diversity.
To assess the alpha-diversity of the intestinal microbiota, defined as the average diversity of species in an ecosystem, the Shannon index will be used. A significant difference between both groups (synbiotic and placebo) will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval.
Genetic markers of inflammation and metabolic pathways will be analyzed from the faeces samples, in order to identify different clusters of these pathways and determine the potential functions of gut microbiota. For that purpose, transcriptome will be quantified with nanostring techology. The relative quantity of gene expression (fold change) of each gene will be calculated with the comparative 2-ΔΔCT method, and significant differences will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval.
Psychological parameters will include anxiety and depression symptoms. Anxiety and depression will be quantified using a validated scale called Depression Anxiety and Stress Scale 21 (DASS-21), which focuse on psychological symptoms and to diagnose both anxiety and depression disorders. In this scale, in depression questions, a score of 0-9 indicates normality, 10-13 mild depression, 14-20 moderate depression, 21-27 severe depression, and \>27 extreme severe depression; in anxiety scale, a score of 0-7 reflects normality, 8-9 mild anxiety, 10-14 moderate, 15-19 severe, and \>19 extreme severe anxiety; in stress scale, a score of 0-14 indicates normality, 15-18 mild stress, 19-25 moderate stress, 26-33 severe stress, and \>33 extreme severe stress.
Study locations
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