Probiotics in Obesity Management

August 15, 2026 updated by: Wecare Probiotics Co., Ltd.

Efficacy and Safety of Pasteurized Akkermansia Muciniphila Akk11 in Obesity/Overweight Weight Management and Energy Metabolism:a Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Luoyang, Henan, China, 471000
        • The School of Food and Bioengineering, Henan University of Science and Technolog

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group
Pasteurized Akkermansia muciniphila Akk11 capsule, 100 billion TFU/day
Dietary supplement: 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)
Placebo Comparator: Placebo group
Placebo capsule, one capsule/day
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight before and after intervention
Time Frame: Week 0 , Week 4, Week 8, Week 12
Measured using a calibrated scale
Week 0 , Week 4, Week 8, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2025

Primary Completion (Actual)

December 3, 2025

Study Completion (Actual)

January 28, 2026

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 15, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WK20250424

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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