Obesity
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbiotc
The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)
DIETARY_SUPPLEMENTPlacebo
The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. A body mass index (BMI) of 24 kg/m² or above; 2. Voluntarily signing an informed consent form to take part in the study; 3. Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet; 4. No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes.
Exclusion criteria
1. Intake of products akin to the test product in the recent period that might sway the outcomes; 2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions; 3. Being pregnant, breastfeeding, or planning to conceive; 4. Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus; 5. Use of antibiotics in the preceding three months; 6. Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible; 7. Smoking in excess of 10 cigarettes daily; 8. Hypersensitivity to probiotic products; 9. Any other participants deemed unsuitable for the research by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight before and after intervention | Week 0 , Week 4, Week 8, Week 12 | Measured using a calibrated scale |
Countries
China
Outcome results
None listed