Weight Loss Effect of Akkermansia Muciniphila in Obese Patients

NCT06780007 | Completed

• 1 other identifier: WK2025003
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Probiotic group

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic 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).

Probiotic group

Placebo 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss

You may not qualify if:

• Pregnant or lactating women, in the reproductive period and not taking contraceptive measures;
• Oral antibiotics in the past 1 month prior to enrollment;
• No use of probiotic prebiotic products before 3 weeks of intervention;
• people without a fitness fat loss program or history of gastric surgery during the intervention period;
• Patients with severe gastrointestinal diseases;
• Those who are known to be allergic to synbiotics or similar products;
• Patients with no self-awareness and those with mental abnormalities;
• Have a history of organ transplantation or malignant tumor disease;
• Concurrent use of other experimental drugs or in other clinical trials;
• Have a history of alcohol, tobacco and other drug abuse;
• Those who are expected to be unable to complete the magnetic resonance examination;
• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital, the Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jiangpeng Wei, Doctor

  The First Affiliated Hospital, the Air Force Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double(participant, investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 17, 2025
• Study Start: January 21, 2025
• Primary Completion: February 28, 2025
• Study Completion: June 16, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

CN (1)