Status:
RECRUITING
Research on Probiotics in Improving Obesity
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 circ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06964919
Start Date
May 10 2025
End Date
August 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