Overview
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Use of products similar to the test product in the near term that may affect the results;
- Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergies;
- Pregnant, breastfeeding, or planning pregnancy;
- Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
- Antibiotic use within the past three months;
- Failure to consume the test product as required or attend follow-ups on time, making efficacy assessment impossible;
- Smoking more than 10 cigarettes a day;
- Allergy to probiotic products;
- Other participants deemed unsuitable for the study by the investigator.