NCT06987279RecruitingNot Applicable
Lactobacillus Plantarum Lp90 and Hormonal Regulation in Obese Women：A Randomized, Double-Blind, Placebo-Controlled Trial
Wecare Probiotics Co., Ltd.1 site in 1 country100 target enrollmentStarted: June 10, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Wecare Probiotics Co., Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The changes of estradiol before and after the intervention
Study Overview
Brief Summary
To evaluate the regulatory effect of Lactobacillus plantans Lp90 formula on visceral fat metabolism and sex hormone balance in obese women.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 18 to 40 years old, female, BMI ≥ 25 kg/m
- •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.
Arms & Interventions
Placebo Group
Placebo Comparator
Taking maltodextrin 3 g/day.
Intervention: Maltodextrin (Dietary Supplement)
Probiotic Group
Experimental
Take Lactobacillus plantarum Lp90 at 30 billion CFU per day.
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
The changes of estradiol before and after the intervention
Time Frame: 0, 1, 2, 3 months
The serum estrogen content of the subjects before and after the intervention was detected by enzyme-linked immunosorbent assay.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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