A human study to evaluate the effect of Platycodi radix water extract on blood triglyceride levels
- Conditions
- Factors influencing health status and contact with health servisces
- Registration Number
- KCT0002861
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 96
1) Subject who voluntarily agree to participate and signs informed consent form
2) Men and women over 20 years old (ratio of men and women 1:1)
3) Blood triglyceride levels less than 200mg/dL
4) Subject who comply with dietary and lifestyles guidelines for intervention period
1) Continuous consumption of health functional food(phytosterol, omega-3 fatty acid, plantagis Semen, aloe, kito acid, onion extract, Indigestible maltodextrin, pure cuttlefish oil, globin hydrolysate), medicine(Lipid-lowering agents, blood glucose-lowering drugs, antihypertensive drugs, anti-inflammatory agents, anticoagulant drug), and oriental medicine that affect blood glucose, lipid, body fat metabolism within 1 months before the first visit
2) History or current abuse of alcohol, or intake = 420 g pure alcohol/week.
(e.g. more than 7 bottles of soju/week).
3) Following diseases
? Liver dysfunction, Diabetes, renal dysfunction, interstinal disease, lactose intolerance, chronic inflammatory disease, thyroid disease, severe muscular skeletal disease
? Severe wasting diseases: malignant tumor
? Mental diseases: schizophrenia, depression
? Cardiovascular and cerebrovascular diseases: hypertension(systolic blood pressure = 160 mmHg, diastolic blood pressure = 100 mmHg), myocardial infarction, stroke
? Anemia, asthma and allergic diseases
4) Women who maintaining hormone therapy
5) Participation in weight management program or weight loss of more than 10% of body weight ?
6) regulary excessive exercise more than 10 hours/week
7) excessive smoking more than 20 cigarettes/day
8) Recommended food score more than 36
9) Body mass index (kg/m2) less than 20 or more than 30
10) Known hypersensitivity to study product or any ingredient in study product
11) Participation in another clinical trial within 4 weeks of enrollment into the study.
12) Pregnant or lactating women
13) Subject who has difficult to handle smartphone
14) Any condition that the Principal Investigator believes may put the subject at undue risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood triglyceride;Total cholesterol, VLDL cholesterol, LDL cholesterol and HDL cholesterol;Apolipoprotein B48
- Secondary Outcome Measures
Name Time Method Blood glucose;Insulin