A human trial of Fermented soybean(Doenjang powder)on intestinal microflora and menopausal women's health
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0008958
- Lead Sponsor
- Wonkwang University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
1) Women aged 45-70 years at the screening test
2) Postmenopausal women(amenorrhea for more than 12 months)
3) BMI = 23 kg/m^2 at the screening test
4) Subjects who agree to participated in the study and sign the informed consent form at the screening test
1) Women who is taking hormone therapy within 3 months prior to the trial
2) History of endometrial proliferation, uterine carcinoma, endometrial cancer, breast cancer, or sex hormone-related cancer
3) A person who has received or has received chemotherapy or radiation therapy that may affect ovarian function
4) Those with a history of significant hypersensitivity reactions to soybean and Doenjang ingredients
5) Patients who have received antipsychotic medication within three months before screening test
6) Patients who have or are suspected of alcoholism or substance abuse
7) Patients who have participated in other human trials within three months before screening test
8) Laboratory test by show the following results
? ALT, AST > 3-fold of normal range
? Serum creatinine > 2.0 mg/dl
9)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes of intestinal microbiome;Modified Kupperman’s index
- Secondary Outcome Measures
Name Time Method Inbody;anthropometric index;lipid metabolism index;inflammatory index;blood glucose related index;monoenoic fatty acid