Effectiveness and Safety of Inactivated Akkermansia Muciniphila Akk11 for Weight and Energy Metabolism in Obesity/Overweight: a Randomized, Double-blind, Placebo-controlled Trial
Assess the effects of Akkermansia muciniphila Akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, BMI, body fat rate, waist - hip ratio (WC), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), triglycerides (TG)) in overweight/obese adults.
• A body mass index (BMI) of ≥25 kg/m²;
• Willingness to provide written informed consent to participate in the study;
• Agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet;
• No plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception.