Double Blinded Placebo Controlled Feasibility Study to Evaluate a Combination Probiotic in Adults With Obesity

What this Trial Is About

Researchers are investigating a combination probiotic treatment for adults with obesity and food addiction, addressing the limitations of current obesity management methods such as diet, exercise, behavioral interventions, and bariatric surgery. The study highlights the challenges of sustained weight loss and the barriers associated with surgery and existing medications. Probiotics have shown promise in preclinical models for reducing obesity, making this an important area of exploration. Participants will be randomly assigned to receive either a dietary supplement probiotic or a placebo once daily for three months. The study is triple-blinded and compares the effects of the probiotic combination to placebo in adults aged 18 to 50 with a body mass index (BMI) between 25 and 40. The intervention period lasts 90 days, during which participants continue lifestyle modifications alongside the supplement. During the study, participants will collect stool samples at home and attend clinic visits at baseline, mid-study (6 weeks), and the end of the study (12 weeks) for blood sample collection and physical measurements like BMI and waist circumference. Various assessments include metabolite and microbiome analysis, stress response tests, blood pressure monitoring, and cognitive tasks. Questionnaires on diet are also completed. The research team will closely monitor changes and safety throughout the 12-week period.

Probiotic Intervention Study