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Probiotics in Obesity Management

Probiotics in Obesity Management

Recruiting
18-65 years
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. A body mass index (BMI) of 25 kg/m² or above;
  2. Voluntarily signing an informed consent form to take part in the study;
  3. Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet;
  4. No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes.

Exclusion Criteria:

  1. Intake of products akin to the test product in the recent period that might sway the outcomes;
  2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions;
  3. Being pregnant, breastfeeding, or planning to conceive;
  4. Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
  5. Use of antibiotics in the preceding three months;
  6. Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible;
  7. Smoking in excess of 10 cigarettes daily;
  8. Hypersensitivity to probiotic products;
  9. Any other participants deemed unsuitable for the research by the investigator.

Study details
    Obesity

NCT06964932

Wecare Probiotics Co., Ltd.

15 October 2025

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