Efficacy and Safety of Pasteurized Akkermansia Muciniphila Akk11 in Obesity/Overweight Weight Management and Energy Metabolism:a Randomized, Double-blind, Placebo-controlled Trial
Evaluate the effects of pasteurized Akkermansia muciniphila Akk11 (killed bacteria) capsules compared to placebo on body composition parameters (including weight, BMI, body fat percentage, waist - hip ratio (WHR), wrist circumference, visceral fat area, and basal metabolic rate) and blood lipid levels (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), and triglycerides (TG)) in overweight or obese adults.
• A body mass index (BMI) of 25 kg/m² or above;
• Voluntarily signing an informed consent form to take part in the study;
• Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet;
• No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes.