Lactobacillus Plantarum and Hormonal Regulation in Obese Women

NCT ID: NCT06987279

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2025-12-10

Brief Summary

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

Detailed Description

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Conditions

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Obesity, Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Probiotic Group

Take Lactobacillus plantarum Lp90 at 30 billion CFU per day.

Group Type EXPERIMENTAL

Probiotic

Intervention Type 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

Taking maltodextrin 3 g/day.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type 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).

Interventions

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Probiotic

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).

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Age: 18 to 40 years old, female, BMI ≥ 25 kg/m2.
2. Be willing to receive follow-up during the intervention period.
3. Be willing to provide two blood, urine and fecal samples during the intervention period.
4. Be willing to take the compound probiotics by oneself every day during the intervention period.
5. Have good hearing and be able to hear and understand all instructions during the intervention period.

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Exclusion Criteria

1. Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease).
2. 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).
3. Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder.
4. Take medication for depression or low mood.
5. Suffering from internal organ failure (such as heart, liver or kidney failure, etc.).
6. Have received radiotherapy or chemotherapy in the past.
7. 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.
8. Have suffered from hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuwai Central-China Cardiovascular Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingpeng Tian, Doctor

Role: CONTACT

13671979116 ext. +86

Facility Contacts

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Yingpeng Tian

Role: primary

13671979116

Other Identifiers

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WK20250515

Identifier Type: -

Identifier Source: org_study_id

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