Lactobacillus Plantarum and Hormonal Regulation in Obese Women
ConditionObesity, Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorWecare Probiotics Co., Ltd.
About this trial
To evaluate the regulatory effect of Lactobacillus plantans Lp90 formula on visceral fat metabolism and sex hormone balance in obese women.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic
Dietary supplementThe 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).
Maltodextrin
Dietary supplementThe 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).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Probiotic GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
0, 1, 2, 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov