Probiotics for hormone balance, body composition, and mood in obese women.

Modulatory Effects of L. Rhamnosus LRa05 and L. Reuteri LR08 Probiotics on Hormone Metabolism, Body Composition, and Mood in Obese Women

This project will try a daily probiotic supplement to see if it reduces visceral belly fat, balances sex hormones, and improves mood in women aged 18–40 with a BMI of 25 or higher.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Wecare Probiotics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT07013409 on ClinicalTrials.gov

What this trial studies

Sponsored by Wecare Probiotics and conducted at The First Affiliated Hospital of Zhengzhou University, this interventional study gives compound probiotics or a maltodextrin control to women with BMI ≥25. Participants take the assigned product daily, attend follow-up visits, and provide blood, urine, and fecal samples twice during the intervention. Primary outcomes focus on changes in visceral fat metabolism, sex hormone balance, and mood-related measures. Key exclusions include major gastrointestinal diseases, severe neurological disorders, substance dependence, psychotic or bipolar disorders, and current use of antidepressant medication.

Who should consider this trial

Good fit: Women aged 18–40 with BMI ≥25 who can take a daily probiotic, provide two blood, urine, and fecal samples, attend follow-up visits, and do not have excluded medical or psychiatric conditions are ideal candidates.

Not a fit: People with active gastrointestinal diseases, severe neurological conditions, current substance dependence, psychotic or bipolar disorders, or taking antidepressant medication — or those outside the specified age or BMI ranges — are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the probiotic could help reduce visceral fat, improve sex hormone balance, and ease low mood in obese women.

How similar studies have performed: Previous probiotic trials have shown modest effects on gut microbiota and some metabolic markers, but clear evidence that probiotics reduce visceral fat or normalize sex hormones and mood is limited.

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.

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.

Where this trial is running

Zhengzhou, Henan

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Fei Xu, Doctor

Conditions Obesity, Women