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

NCT07013409 | Recruiting

• 1 other identifier: WK20250603
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the regulatory effect of probiotics 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 30 billion CFU of complex probiotics every day (Lacticaseibacillus rhamnosus LRa05: Limosilactobacillus reuteri LR08= 1:1).

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)

The First Affiliated Hospital of Zhengzhou University

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

Fei Xu, Doctor

CONTACT

18623716648; xu.fei@haut.edu.cn

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: June 2, 2025
• First Posted: June 10, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 10, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-06

Locations

CN (1)