Weight Loss Effect of Akkermansia Muciniphila in Obese Patients

Effect of Akkermansia Muciniphila Akk11 on Weight Loss in Obese Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study.

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.

Study Overview

• Status: Completed
• Conditions: 28≤BMI≤35Kg/m2
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • The First Affiliated Hospital, the Air Force Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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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informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; 10B AFU/four capsules/day Akk11, before meals; Storage: store in a cool, dry place without sun exposure.	Dietary supplement: 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).
Placebo Comparator: Placebo group; Four maltodextrin capsules/day, before meals; Storage: store in a cool, dry place without sun exposure.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index(BMI)	BMI = Weight (kg) / [Height (m)]². 24kg/m² ≤ BMI < 28 kg/m² is in the overweight range, and BMI ≥ 28 kg/m² is in the obesity range.	Day 0, week4, week8, week12.

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.
• Investigators: Principal Investigator: Jiangpeng Wei, Doctor, The First Affiliated Hospital, the Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 30, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Substandard Drugs; Pharmaceutical Preparations; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Counterfeit Drugs; Probiotics
• Other Study ID Numbers: WK2025003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No