Obesity, Women
Conditions
Brief summary
To evaluate the regulatory effect of Lactobacillus gasseri LG08 formula on visceral fat metabolism and sex hormone balance in obese women.
Interventions
DIETARY_SUPPLEMENTProbiotic
The trial period of this study is 12 weeks, and each patient will undergo 4 visits (in week 0, week 4, week 8, and week 12).
DIETARY_SUPPLEMENTMaltodextrin
The trial period of this study is 12 weeks, and each patient will undergo 4 visits (in week 0, week 4, week 8, and week 12).
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 50 Years
Healthy volunteers
Yes
Inclusion criteria
(1) female sex, aged 18-50 years; (2) body mass index (BMI) ≥ 25 kg/m2; (3) willingness to maintain habitual dietary intake and physical activity patterns throughout the study period and to comply with follow-up visits, sample collection, and questionnaire completion; (4) ability to complete blood sampling during the early follicular phase of the menstrual cycle (days 3-5), as confirmed by self-reported menstrual timing. \-
Exclusion criteria
(1) pregnancy or lactation; (2) presence of chronic diseases or endocrine/metabolic disorders (e.g., diabetes mellitus, thyroid disorders); (3) recent use of medications or dietary supplements that could affect endocrine or metabolic function; (4) non-compliance with the required washout period or prohibited use of probiotic products during the study; (5) any other conditions deemed by the investigators to be unsuitable for participation. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of estradiol before and after the intervention | Week 0 and Week 12 | 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