Overweight or Obesity
Conditions
Brief summary
To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.
Interventions
DIETARY_SUPPLEMENTProbiotic
The trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8)
DIETARY_SUPPLEMENTPlacebo
The trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8)
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18-45 years old; 2. BMI ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%； 3. Normal liver function indexes; 4. Willing to complete study-related questionnaires and diaries and complete all clinical visits.
Exclusion criteria
1. Those who have been diagnosed with high uric acid or gout are not recommended to participate in the test; 2. Psychiatric or neurological diseases, celiac disease, lactose intolerance, allergies; 3. Have the following diseases: irritable bowel syndrome, ulcerative colitis, fatty liver, liver cirrhosis, etc.; 4. Recently treated with antibiotics (i.e., \< 3 months prior to the start of the study); 5. Participants who smoked more than 10 cigarettes per day were excluded; 6. It is not recommended to participate in other special circumstances, such as those who are allergic to probiotic products; 7. Pregnant and lactating women are not suitable for experiments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum concentrations of leptin before and after intervention. | week 0 and week 8 | Detected by enzyme-linked immunosorbent assay (ELISA). |
| Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention. | week 0 and week 8 | Detected by enzyme-linked immunosorbent assay (ELISA). |
| Changes in serum concentrations of peptide YY before and after intervention. | week 0 and week 8 | Detected by enzyme-linked immunosorbent assay (ELISA). |
Countries
China
Outcome results
None listed