Obesity
Conditions
Brief summary
To evaluate the impact of pasteurized Akkermansia muciniphila Akk11 capsules versus placebo on body composition (including body weight, BMI, body fat percentage, waist-to-hip ratio, wrist circumference, visceral fat area, and basal metabolic rate) and serum lipid parameters (TC, LDL-C, HDL-C, and TG) in overweight and obese adults.
Interventions
DIETARY_SUPPLEMENTProbiotic
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. Body mass index (BMI) ≥ 24 kg/m²; 2. Able and willing to provide written informed consent; 3. Willing to comply with the study protocol and required restrictions, including adherence to a low-carbohydrate, energy-restricted diet; 4. No intention to conceive from 14 days prior to screening until 6 months after study completion, and agreement to use effective contraception during this period
Exclusion criteria
1. Recent use of products with similar functions to the investigational product that may interfere with study outcomes; 2. History of psychiatric or neurological disorders, celiac disease, lactose intolerance, or known allergies; 3. Pregnant or breastfeeding women, or those planning to become pregnant during the study period; 4. Diagnosis of irritable bowel syndrome (IBS), ulcerative colitis, liver cirrhosis, or diabetes mellitus; 5. Use of antibiotics within 3 months prior to screening; 6. Inability to comply with the study protocol, including failure to take the investigational product as required or attend scheduled follow-up visits; 7. Smoking more than 10 cigarettes per day; 8. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in body weight following the intervention | Baseline (Week 0) and Weeks 4, 8, and 12 | Body weight will be assessed using a calibrated digital scale under standardized conditions |
Countries
China
Contacts
CONTACTYing Wu, doctor
Outcome results
None listed