A human study to evaluate effects of Platycodi radix water extract on postprandial blood triglycerides: a randomized, double-blind, cross-over, placebo-controlled study
- Conditions
- Not Applicable
- Registration Number
- KCT0002296
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
1) Subject who voluntarily agree to participate and signs informed consent form
2) 20 years= Age <40 years (Ratio of men and women 1:1)
3) Subject who comply with dietary/exercise 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 = 140 g pure alcohol/week (e.g. more than 2.5 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) Subject who controlling body weight or subjects who have changed of body weight more than 10% within 6 months before the first visit
6) Excessive exercise (= 10 hours / week)
7) Chronic smoker (= 20 cigarettes / day)
8) Recommended Food Score > 36
9) Case of less than 18.5kg/m2 or greater than 30.0kg/m2 in BMI
10) Known hypersensitivity to study product or any ingredient in study product
11) Participation in other human study within 1 month before the first visit
12) Pregnant or lactating women
13) Subject who has difficult to handle smartphone
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood triglyceride
- Secondary Outcome Measures
Name Time Method Body Mass Index(BMI),Height,Weight