Obesity
Conditions
Brief summary
Assess the effects of Akkermansia muciniphila Akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, BMI, body fat rate, waist - hip ratio (WC), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), triglycerides (TG)) in overweight/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. A body mass index (BMI) of ≥24 kg/m²; 2. Willingness to provide written informed consent to participate in the study; 3. Agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet; 4. No plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception.
Exclusion criteria
1. Use of products similar to the test product in the near term that may affect the results; 2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergies; 3. Pregnant, breastfeeding, or planning pregnancy; 4. Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus; 5. Antibiotic use within the past three months; 6. Failure to consume the test product as required or attend follow-ups on time, making efficacy assessment impossible; 7. Smoking more than 10 cigarettes a day; 8. Allergy to probiotic products; 9. Other participants deemed unsuitable for the study 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 |
| Change in BMI before and after intervention | Week 0 , Week 4, Week 8, Week 12 | Measured using a calibrated scale and stadiometer |
| Change in waist-hip ratio (WC) before and after intervention | Week 0 , Week 4, Week 8, Week 12 | Measured using a non-elastic measuring tape |
| Change in wrist circumference before and after intervention | Week 0 , Week 4, Week 8, Week 12 | Measured using a non-elastic measuring tape |
| Change in visceral fat area before and after intervention. | Week 0 , Week 4, Week 8, Week 12 | Measured using bioelectrical impedance analysis (BIA) |
| Change in basal metabolic rate (BMR) before and after intervention | Week 0 , Week 4, Week 8, Week 12 | Measured using indirect calorimetry |
| Change in serum total cholesterol (TC) concentration before and after intervention | Week 0 and Week 12 | Detected by enzyme-linked immunosorbent assay (ELISA) |
| Change in low-density lipoprotein (LDL) concentration before and after intervention | Week 0 and Week 12 | Detected by enzyme-linked immunosorbent assay (ELISA) |
| Change in high-density lipoprotein (HDL) concentration before and after intervention | Week 0 and Week 12 | Detected by enzyme-linked immunosorbent assay (ELISA) |
| Change in triglyceride (TG) concentration before and after intervention. | Week 0 and Week 12 | Detected by enzyme-linked immunosorbent assay (ELISA) |
Countries
China
Outcome results
None listed