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Completed

NCT Number: NCT07502404

Lactobacillus Gasseri and Hormonal Regulation in Obese Women

To evaluate the regulatory effect of Lactobacillus gasseri LG08 formula on visceral fat metabolism and sex hormone balance in obese women.

Completed

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Central-China Cardiovascular Hospital

Zhengzhou, Henan, 462000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) female sex, aged 18-50 years; (2) body mass index (BMI) ≥ 25 kg/m2; (3) willingness to maintain habitual dietary intake and physical activity patterns throughout the study period and to comply with follow-up visits, sample collection, and questionnaire completion; (4) ability to complete blood sampling during the early follicular phase of the menstrual cycle (days 3-5), as confirmed by self-reported menstrual timing.

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Exclusion criteria

(1) pregnancy or lactation; (2) presence of chronic diseases or endocrine/metabolic disorders (e.g., diabetes mellitus, thyroid disorders); (3) recent use of medications or dietary supplements that could affect endocrine or metabolic function; (4) non-compliance with the required washout period or prohibited use of probiotic products during the study; (5) any other conditions deemed by the investigators to be unsuitable for participation.

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Treatment and study plan

Probiotic

Dietary Supplement

The trial period of this study is 12 weeks, and each patient will undergo 4 visits (in week 0, week 4, week 8, and week 12).

Maltodextrin

Dietary Supplement

The trial period of this study is 12 weeks, and each patient will undergo 4 visits (in week 0, week 4, week 8, and week 12).

Primary outcomes

  1. The changes of estradiol before and after the intervention

    Time frame: Week 0 and Week 12

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

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Impact of Lactobacillus Gasseri on Weight Management and Endocrine Function in Overweight Women: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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