The effects of a newly developed beverage powder supplement on anthropometric measures, body composition, metabolic syndrome components, and appetite in obese or overweight adults: a protocol for a randomized clinical trial study.

BACKGROUND

Overweight and obesity result from excessive fat accumulation and pose significant global health challenges linked to various diseases. Recent research suggests that gut microbiota, particularly dysbiosis, is vital in obesity development. Next-generation probiotics, especially Akkermansia muciniphila, alongside compounds found in green tea extract and konjac glucomannan, offer promise in obesity management by enhancing gut microbiota balance and metabolic function. This research investigates a unique supplement that integrates these elements, proposing that it will outperform lifestyle changes alone in improving anthropometric measures, body composition, metabolic metrics, blood pressure, and appetite among overweight or obese adults.

METHODS

This study will include 72 overweight or obese patients, who will be randomly assigned to either the intervention or control group within a randomized, triple-blind controlled clinical trial. The intervention group will consume 2 g of beverage sachets containing pasteurized Akkermansia muciniphila, green tea extract, and konjac glucomannan three times daily. In comparison, the control group will take 2 g of microcrystalline cellulose three times daily for 8 weeks. Evaluations of anthropometry (body mass index, waist and hip circumference), body composition (fat mass, fat-free mass, total body water, etc.), appetite using a visual analogue scale, blood pressure, and biochemical parameters including fasting blood glucose (FBS), total cholesterol (TC), triglycerides (TG), low- and high-density lipoprotein (LDL and HDL) will be conducted.

DISCUSSION: The results of this study will provide evidence for the synergistic effects of Akkermansia muciniphila combined with prebiotics in the management of obesity and its associated metabolic states.

TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT20250222064807N2) (2025/03/26).