Research on Probiotics in Improving Obesity

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.

Inclusion Criteria:

1. A body mass index (BMI) of ≥24 kg/m²;
2. Willingness to provide written informed consent to participate in the study;
3. Agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet;
4. No plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception.

Exclusion Criteria:

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