Lactobacillus Plantarum and Hormonal Regulation in Obese Women

NCT06987279 | Recruiting

• 1 other identifier: WK20250515
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Women

Outcome Measures

Primary Outcomes (1)

• The changes of estradiol before and after the intervention

  The serum estrogen content of the subjects before and after the intervention was detected by enzyme-linked immunosorbent assay.

  0, 1, 2, 3 months

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Take Lactobacillus plantarum Lp90 at 30 billion CFU per day.

Dietary Supplement: Probiotic

Placebo Group

PLACEBO COMPARATOR

Taking maltodextrin 3 g/day.

Dietary Supplement: Maltodextrin

Interventions

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).

Probiotic Group

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).

Placebo Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Fuwai Central-China Cardiovascular Hospital

Zhengzhou, Henan, 462000, China

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Yingpeng Tian, Doctor

CONTACT

13671979116; tianyingpeng2021@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: June 10, 2025
• Primary Completion: September 10, 2025
• Study Completion: December 10, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

CN (1)