About this trial
To evaluate the impact of pasteurized Akkermansia muciniphila Akk11 capsules versus placebo on body composition (including body weight, BMI, body fat percentage, waist-to-hip ratio, wrist circumference, visceral fat area, and basal metabolic rate) and serum lipid parameters (TC, LDL-C, HDL-C, and TG) in overweight and obese adults.
Eligibility criteria
Qualifiers
Body mass index (BMI) ≥ 24 kg/m²;
Able and willing to provide written informed consent;
Willing to comply with the study protocol and required restrictions, including adherence to a low-carbohydrate, energy-restricted diet;
No intention to conceive from 14 days prior to screening until 6 months after study completion, and agreement to use effective contraception during this period
Disqualifiers
Recent use of products with similar functions to the investigational product that may interfere with study outcomes;
History of psychiatric or neurological disorders, celiac disease, lactose intolerance, or known allergies;
Pregnant or breastfeeding women, or those planning to become pregnant during the study period;
Diagnosis of irritable bowel syndrome (IBS), ulcerative colitis, liver cirrhosis, or diabetes mellitus;
Trial design
Treatments tested in this trial
- Probiotic
- Placebo