Obesity, Women
Conditions
Brief summary
To evaluate the regulatory effect of probiotics formula on visceral fat metabolism and sex hormone balance in obese women.
Interventions
DIETARY_SUPPLEMENTProbiotic
The trial period of this study is 3 months, and each patient will undergo 4 visits (in month 0, month 1, month 2, and month 3).
DIETARY_SUPPLEMENTMaltodextrin
The trial period of this study is 3 months, and each patient will undergo 4 visits (in month 0, month 1, month 2, and month 3).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18 to 40 years old, female, BMI ≥ 25 kg/m2. * Be willing to receive follow-up during the intervention period. * Be willing to provide two blood, urine and fecal samples during the intervention period. * Be willing to take the compound probiotics by oneself every day during the intervention period. * Have good hearing and be able to hear and understand all instructions during the intervention period.
Exclusion criteria
* Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease). * Suffering from severe neurological disorders (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, long-term coma - excluding general anesthesia). * Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder. * Take medication for depression or low mood. * Suffering from internal organ failure (such as heart, liver or kidney failure, etc.). * Have received radiotherapy or chemotherapy in the past. * Have received general anesthesia surgery/procedures within the past three years, or plan to receive general anesthesia procedures/surgeries within the next three months during this trial. * Have suffered from hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of estradiol before and after the intervention | 0, 1, 2, 3 months | The serum estrogen content of the subjects before and after the intervention was detected by enzyme-linked immunosorbent assay. |
Countries
China
Outcome results
None listed