Completed

Pasteurized Akkermansia Muciniphila for Weight Management and Energy Metabolism in Overweight and Obesity

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Probiotc

+ Placebo

Dietary Supplement
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 65 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorWecare Probiotics Co., Ltd.
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 15, 2025

Actual date on which the first participant was enrolled.

This clinical trial explores the potential benefits of using pasteurized Akkermansia muciniphila Akk11, a type of killed bacteria, to help manage weight and improve energy metabolism in adults who are overweight or obese. The study aims to see if these capsules can positively affect various body measurements such as weight, BMI, body fat percentage, waist-hip ratio, wrist circumference, visceral fat area, and basal metabolic rate. Additionally, it investigates whether these capsules can improve blood lipid levels, which include total cholesterol, LDL, HDL, and triglycerides. This research is important because finding effective ways to manage weight and improve metabolic health can significantly enhance quality of life and reduce health risks associated with obesity. Participants in the study will take capsules of either the pasteurized Akkermansia muciniphila Akk11 or a placebo. The effects will be measured by monitoring changes in body composition and blood lipid levels over time. This involves evaluating various parameters like body fat and cholesterol levels, which are critical indicators of metabolic health. Although the study does not specify the phase, it is interventional, meaning it involves active treatment to assess the outcomes. The process is designed to ensure safety and efficacy, providing valuable information on the potential role of this bacterial supplement in managing obesity and metabolic health.

Official TitleEfficacy and Safety of Pasteurized Akkermansia Muciniphila Akk11 in Obesity/Overweight Weight Management and Energy Metabolism:a Randomized, Double-blind, Placebo-controlled Trial
NCT06964932
Principal SponsorWecare Probiotics Co., Ltd.
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

4 inclusion criteria required to participate
A body mass index (BMI) of 24 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.

9 exclusion criteria prevent from participating
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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Pasteurized Akkermansia muciniphila Akk11 capsule, 100 billion TFU/day

Group II

Placebo
Placebo capsule, one capsule/day

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Luoyang, ChinaOpen The School of Food and Bioengineering, Henan University of Science and Technolog in Google Maps
CompletedOne Study Center