Clinical trial NCT01278589: Antioxidative Effect of Plantago Asiatica L. Extract
Official title: Acute Effect of Plantago Asiatica L. Extract on Antioxidative Biomarkers in Subjects With Mild Hyperlipidemia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
Collaborators: name: Ministry for Food, Agriculture, Forestry and Fisheries, Korea
First posted: 2011-01-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L. extract in subjects with mild hyperlipidemia.

Detailed description: The purpose of this study is to evaluate an acute effect of Plantago asiatica L. extract consumption on antioxidative biomarkers in subjects with mild hyperlipidemia. Subjects will intake Plantago asiatica L. extract with a high fat meal for oxidative stress loading. Antioxidative biomarkers will be measured after single-dose administration of Plantago asiatica L. extract.

Eligibility criteria: Inclusion Criteria:

* Adults age over 30
* BMI(Body mass index) between 25 and 33 kg/m2
* Total cholesterol between 200mg/dL and 250mg/dL OR Triglyceride between 150mg/dL and 220mg/dL OR LDL-cholesterol between 130mg/dL and 165mg/dL

Exclusion Criteria:

* Subject who has taken part in other clinical trials within 30 days of screening visit
* Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect antioxidative biomarkers within 30days of screening visit
* Subject who is pregnant or breast feeding
* Subject who lost body weight over 4kg within 30days of screening visit
* Alcoholic
* Smoker
* Subject who takes excessive exercise (over 7hours/week)
* Subject who has hypertension(≥140/90mmHg), diabetes(fasting blood glucose ≥126mg/dL), kidney disease, hepatic disease or hyperthyroidism within 2years
* Subject who has an allergy to the ingredients of study product

Primary outcomes:
measure: Comet assay after single-dose consumption of Plantago asiatica L. extract
timeFrame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Secondary outcomes:
measure: Plasma FRAP
timeFrame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
measure: Plasma MDA
timeFrame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
measure: Plasma FFA
timeFrame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
measure: Plasma ox-LDL
timeFrame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
measure: Plasma erythrocyte SOD
timeFrame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
measure: Plasma triglyceride
timeFrame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University / Hanaro Medical Foundation
Study officials:
affiliation: Ewha Womans University
name: Oran Kwon, Ph.D
role: PRINCIPAL_INVESTIGATOR
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