Probiotics in Obesity Management

Not Applicable

Recruiting

• Conditions: Obesity

• Registration Number: NCT06964932
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-22
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-05-15
• Primary Completion: 2026-07-03
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in body weight before and after intervention	Week 0 , Week 4, Week 8, Week 12	Measured using a calibrated scale

Trial Locations

Locations (1)

The School of Food and Bioengineering, Henan University of Science and Technolog; 🇨🇳 Luoyang, He Nan, China