A human trial of Fermented soybean(Doenjang powder) on intestinal microflora and improvement of blood cholesterol
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008862
- Lead Sponsor
- Jeonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
1) Adult men and women aged 19 years or older and 75 years old or younger at the screening test.
2) Subjects with an LDL-cholesterol of 130 mg/dL or more or a total cholesterol of 200 mg/dL or more in a fasting blood test at the screening test.
1) Those with clinically significant acute or chronic cardiocerebrovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory and hematologic neoplastic, gastrointestinal, systemic and infectious diseases requiring treatment.
2) Those who have taken medicines and health functional foods related to improving intestinal flora and cholesterol within 1 month before screening
3) Those who are taking diabetes medications at the screening test.
4) Patients with uncontrolled hypertension at the screening test.
5) Those who have received antipsychotic drug treatment within 3 months prior to screening test.
6) Those with or suspected of alcoholism or drug abuse
7) pregnant or lactating women
8) Women of childbearing potential who do not accept the practice of adequate contraception
9) Those who participated in other human application tests within 3 months prior to screening test.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change of intestinal microbiome;lipid metabolism index
- Secondary Outcome Measures
Name Time Method lipid metabolism index;Atherogenic index;inflammatory markers;Short chain fatty acids