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

Not Applicable

Recruiting

• Conditions: Obesity, Women

• Registration Number: NCT07013409
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-10
• Study Start: 2025-07-01
• Last Update Submitted: 2025-09-01
• Last Update Posted: 2025-09-08
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The changes of estradiol before and after the intervention	0, 1, 2, 3 months	The serum estrogen content of the subjects before and after the intervention was detected by enzyme-linked immunosorbent assay.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China