Probiotics in Obesity Management

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Probiotc

Placebo

Clinical Study ID

NCT06964932

WK20250424

Ages 18-65
All Genders
Accepts Healthy Volunteers

Study Summary

Evaluate the effects of pasteurized Akkermansia muciniphila Akk11 (killed bacteria) capsules compared to placebo on body composition parameters (including weight, BMI, body fat percentage, waist - hip ratio (WHR), wrist circumference, visceral fat area, and basal metabolic rate) and blood lipid levels (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), and triglycerides (TG)) in overweight or obese adults.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 asadhering to a calorie - restricted - low carbohydrate diet;
No intention to become pregnant from 14 days before screening, and commitment tousing effective contraception until six months after the trial concludes.

Exclusion

Exclusion Criteria:

Intake of products akin to the test product in the recent period that might sway theoutcomes;
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;
Use of antibiotics in the preceding three months;
Inability to comply with the test product regimen or attend follow-up visitsregularly, making efficacy assessment unfeasible;
Smoking in excess of 10 cigarettes daily;
Hypersensitivity to probiotic products;
Any other participants deemed unsuitable for the research by the investigator.

Study Design