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Lactobacillus Plantarum and Hormonal Regulation in Obese Women

Lactobacillus Plantarum Lp90 and Hormonal Regulation in Obese Women:A Randomized, Double-Blind, Placebo-Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06987279
Enrollment
100
Registered
2025-05-23
Start date
2025-06-10
Completion date
2025-12-10
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Women

Brief summary

To evaluate the regulatory effect of Lactobacillus plantans Lp90 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.
Lead SponsorINDUSTRY

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

1. Age: 18 to 40 years old, female, BMI ≥ 25 kg/m2. 2. Be willing to receive follow-up during the intervention period. 3. Be willing to provide two blood, urine and fecal samples during the intervention period. 4. Be willing to take the compound probiotics by oneself every day during the intervention period. 5. Have good hearing and be able to hear and understand all instructions during the intervention period. \-

Exclusion criteria

1. Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease). 2. 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). 3. Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder. 4. Take medication for depression or low mood. 5. Suffering from internal organ failure (such as heart, liver or kidney failure, etc.). 6. Have received radiotherapy or chemotherapy in the past. 7. 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. 8. Have suffered from hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past. \-

Design outcomes

Primary

MeasureTime frameDescription
The changes of estradiol before and after the intervention0, 1, 2, 3 monthsThe serum estrogen content of the subjects before and after the intervention was detected by enzyme-linked immunosorbent assay.

Countries

China

Contacts

Primary ContactYingpeng Tian, Doctor
tianyingpeng2021@163.com13671979116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026