Probiotics in Obesity Management

NCT ID: NCT06964932

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2026-01-28

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Probiotic group

Pasteurized Akkermansia muciniphila Akk11 capsule, 100 billion TFU/day

Group Type: EXPERIMENTAL

Probiotc

Intervention Type: DIETARY_SUPPLEMENT

The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)

Placebo group

Placebo capsule, one capsule/day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)

Interventions

Probiotc

The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. A body mass index (BMI) of 24 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The School of Food and Bioengineering, Henan University of Science and Technolog

Luoyang, Henan, China

Countries

China

Other Identifiers

WK20250424

Identifier Type: -

Identifier Source: org_study_id