A Randomized, Double-blind, Placebo-controlled Intervention Study to evaluate the Efficacy and Safety of Barley Sprout” Extraction BS-1 in Healthy Volunteer with high cholesterol
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0003434
- Lead Sponsor
- Kyung Hee University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 78
1) Men and women aged 20 to under 79
2) 200 mg/dl = Total cholesterol= 239 mg/dl
3) 130 mg/dl = LDL cholesterol = 159 mg/dl
4) Subjects who agree to participate in this study and have given their written informed consent
1) Currently taking drugs for the control of hyperlipidemia or the improvement of blood circulation
2) HDL cholesterol = 40mg/dl
3) 200 mg/dl = TG(Triglyceride)
4) Subjects who experienced adverse reactions such as allergies when taking sprouts barley products
5) Subjects who have a history of renal failure, liver disease (hepatitis, liver cirrhosis, liver cancer), psychiatric disorders such as dementia, major depression, generalized anxiety disorder
6) History or presence of clinically significant medical condition such as stroke, heart disease (heart failure, angina, myocardial infarction), malignant disease, narrow angle glaucoma, resistant hypertension, lung disease, systolic blood pressure greater than 180 mmHg in hypertension
7) Subjects who have clinical manifestation associated renal or hepatic disorders (serum creatinine > 2.0 mg/dL, liver function test: ALT, AST > 2.5 times of the upper limit of normal range)
8)Subjects who show the following results;
- Fasting blood glucose 160 mg/dL, despite of taking oral antidiabetic agents
- Platelet 150,000/mm3, WBC 3,000/mm3, Hemoglobin 9.5 g/dL for men or 9.0 g/dL for women
9) History or presence of any clinically significant medical condition such as hypertension, diabetes or smokers, (When two or more are applicable)
10) Use of the medications or products such as oral steroid, hormones within 12 weeks prior to the scheduled study drug administration. Subjects who have been taking medication or functional food, known to interfere with the absorption, metabolism and elimination of study drug (test food) or Subjects who participated in any other clinical trial within 3 months prior to the scheduled study drug administration
11) Subjects who have undergone surgical procedures within 6 months prior to the scheduled study drug administration or who have are taking medications (treatment for acupuncture or blood circulation improvement or health food,drug that may cause abuse) within 1 months prior to the scheduled study drug administration
12) Pregnant and lactating women
13) Subjects who do not follow informed-consent rules, or who are judged by the investigator to be inappropriate for inclusion in the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL cholesterol reduction rate, total cholesterol reduction rate, HDL cholesterol change rate
- Secondary Outcome Measures
Name Time Method Total cholesterol reduction amount, LDL cholesterol reduction amount, HDL cholesterol change amount, TG reduction ratio and reduction amount;Laboratory tests (hematology, blood biochemistry, urinalysis), Adverse event