A human study to evaluate effects of Platycodi radix water extract on postprandial blood triglycerides: a randomized, double-blind, cross-over, placebo-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002296

Enrollment

Registered

2017-04-05

Start date

2017-05-29

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : After 1-week run-in period, subjects are randomly assigned to to one of the six sequence. Each sequence is consist of intervention groups (control group or Platycodi radix water e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Blood triglyceride	—

Secondary

Measure	Time frame
Body Mass Index(BMI),Height,Weight	—

Countries

Korea, Republic of

Contacts

Public ContactHansol Lee

Ewha Womans University

Outcome results