RecruitingNot ApplicableNCT06987279

Lactobacillus Plantarum and Hormonal Regulation in Obese Women

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


Sponsor

Wecare Probiotics Co., Ltd.

Enrollment

100 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria6

  • 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 Criteria9

  • 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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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).


Locations(1)

Fuwai Central-China Cardiovascular Hospital

Zhengzhou, Henan, China

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NCT06987279


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