None listed
Conditions
Interventions
Dietary Supplement : After breakfast 30 minutes later take a capsule containing Barley Sprout extraction or Placebo for 12 weeks.
- once a day, 2capsuls(1cap:500mg)/time (total 1,000mg)
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol reduction rate, total cholesterol reduction rate, HDL cholesterol change rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactKEUM-RAN JEONG
Kyung Hee University Hospital
Outcome results
None listed