Lactobacillus Gasseri and Hormonal Regulation in Obese Women

NCT07502404 | Completed

• 1 other identifier: WK20260325
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the regulatory effect of Lactobacillus gasseri LG08 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.

  Week 0 and Week 12

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Take Lactobacillus gasseri LG08 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 12 weeks, and each patient will undergo 4 visits (in week 0, week 4, week 8, and week 12).

Probiotic Group

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).

Placebo Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Fuwai Central-China Cardiovascular Hospital

Zhengzhou, Henan, 462000, China

Location

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

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: March 25, 2026
• First Posted: March 31, 2026
• Study Start: April 28, 2025
• Primary Completion: July 21, 2025
• Study Completion: October 25, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)