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OpenTrials
Completed

NCT Number: NCT07013409

Probiotics' Effects on Hormones, Body and Mood in Obese Women

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

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Key information

Conditions

Obesity, Women Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 462000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Probiotic

Dietary Supplement

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).

Maltodextrin

Dietary Supplement

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Safety and Efficacy of Lacticaseibacillus Rhamnosus LRa05, Lactobacillus Crispatus LCr86 and Limosilactobacillus Reuteri LR08 on Hormone Metabolism, Body Composition, and Emotional Regulation in Overweight Women

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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