Study of a Postbiotic Supplement and Nutrition Advice in Overweight and Obese Adults to Improve Body Composition and Metabolic Health

What this Trial Is About

Researchers are studying the effects of a postbiotic supplement on body composition and other health factors in overweight or obese adult men and women. The study aims to observe changes in body weight, glucose tolerance, gut microbiota, metabolites, biochemical markers related to metabolism and obesity, physical activity levels, and adherence to nutritional recommendations. This randomized controlled trial involves 114 participants, including a 10% allowance for dropout. Participants will be randomly assigned to one of two groups for 12 weeks an experimental group receiving nutritional advice plus a daily gummy containing a postbiotic supplement, and a placebo group receiving nutritional advice plus a daily gummy without the active supplement. They will visit the nutritional intervention unit at the start and end of the 12-week period, with a follow-up phone call at week 6. During the study, participants will attend two clinical visits where body measurements, blood pressure, and samples of blood, urine, and stool will be collected. Researchers will also gather data on diet, physical activity, sleep, and gastrointestinal symptoms. The main outcome measured is body fat percentage, with various secondary measures including glucose levels, cholesterol, inflammation markers, gut microbiota, and quality of life. Participants adherence to the supplement and nutritional guidelines will be monitored throughout the study.

Effect of a Postbiotic Supplementation in Overweight and Obese Subjects: A Randomized Controlled Trial (PARABIOTICS-2).