Weight Loss Effect of Akkermansia Muciniphila in Obese Patients

NCT ID: NCT06780007

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2025-06-16

Brief Summary

This study intends to study the effect of Akkermansia muciniphila on weight loss and the improvement of blood inflammation and metabolic indexes in obese patients with low Body Mass Index (BMI) through multi-center clinical studies, and for the first time to innovatively explore the weight loss mechanism of Akkermansia muciniphila by comparing the changes in brain function and fecal microbiota before and after intervention.

Conditions

28≤BMI≤35Kg/m2

Study Design

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

Study Groups

Probiotic group

10B AFU/four capsules/day Akk11, before meals; Storage: store in a cool, dry place without sun exposure.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12).

Placebo group

Four maltodextrin capsules/day, before meals; Storage: store in a cool, dry place without sun exposure.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12).

Interventions

Probiotic

The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

-

1) Age 18-65 years old; 2）28≤BMI≤35Kg/m2； 3) Willing and able to comply with the protocol during the study period, and be able to cooperate with the completion of various examinations during the trial. Written informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss

Exclusion Criteria

1. Pregnant or lactating women, in the reproductive period and not taking contraceptive measures;

2. Oral antibiotics in the past 1 month prior to enrollment;

3. No use of probiotic prebiotic products before 3 weeks of intervention;

4. people without a fitness fat loss program or history of gastric surgery during the intervention period;

5. Patients with severe gastrointestinal diseases;

6. Those who are known to be allergic to synbiotics or similar products;

7. Patients with no self-awareness and those with mental abnormalities;

8. Have a history of organ transplantation or malignant tumor disease;

9. Concurrent use of other experimental drugs or in other clinical trials;

10. Have a history of alcohol, tobacco and other drug abuse;

11. Those who are expected to be unable to complete the magnetic resonance examination;

12. Combined with serious medical diseases or conditions: such as clinically serious (i.e., active) cardiac disease, severe, uncontrolled medical diseases and infections, severe uncontrollable digestive disorders, severe electrolyte disorders, active disseminated intravascular coagulation, major organ failure, such as decompensated heart, pulmonary, hepatic, renal failure, peripheral neuropathy symptoms, etc.

• 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

Principal Investigators

Jiangpeng Wei, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, the Air Force Medical University

Locations

The First Affiliated Hospital, the Air Force Medical University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

WK2025003

Identifier Type: -

Identifier Source: org_study_id