Status:
RECRUITING
Probiotics in Obesity Management
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Intake of products akin to the test product in the recent period that might sway the outcomes;
- Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions;
- Being pregnant, breastfeeding, or planning to conceive;
- Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
- Use of antibiotics in the preceding three months;
- Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible;
- Smoking in excess of 10 cigarettes daily;
- Hypersensitivity to probiotic products;
- Any other participants deemed unsuitable for the research by the investigator.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06964932
Start Date
May 15 2025
End Date
September 30 2026
Last Update
May 11 2025
Active Locations (1)
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1
The School of Food and Bioengineering, Henan University of Science and Technolog
Luoyang, Henan, China, 471000