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Recruiting NCT06987279

Lactobacillus Plantarum and Hormonal Regulation in Obese Women

No phase Interventional Obesity, Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probiotic, Maltodextrin.
Who it may be relevant to
Registry conditions: Obesity, Women. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

To evaluate the regulatory effect of Lactobacillus plantans Lp90 formula on visceral fat metabolism and sex hormone balance in obese women.

Interventions

  • Dietary supplement Probiotic
    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 supplement Maltodextrin
    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).

Primary outcome measures

  • The changes of estradiol before and after the intervention [Time frame: 0, 1, 2, 3 months]

Eligibility criteria

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.

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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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Fuwai Central-China Cardiovascular Hospital — Zhengzhou

Identifiers

NCT: NCT06987279 · WK20250515

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗