Weight Loss Effect of Akkermansia Muciniphila in Obese Patients

Wecare Probiotics

Status: Completed

Conditions: 28≤BMI≤35Kg/m2

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06780007

WK2025003

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo