Antioxidative Effect of Plantago Asiatica L. Extract

Not Applicable

Completed

• Conditions: Oxidative Stress
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Plantago asiatica L. extract 5g; Dietary Supplement: Plantago asiatica L. extract 10g; Dietary Supplement: Plantago asiatica L. extract 20g

• Registration Number: NCT01278589
• Lead Sponsor: Ewha Womans University

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Primary Completion: 2011-04
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
• Plantago asiatica L. extract 5g	Plantago asiatica L. extract 5g	-
Plantago asiatica L. extract 10g	Plantago asiatica L. extract 10g	-
Plantago asiatica L. extract 20g	Plantago asiatica L. extract 20g	-

Primary Outcome Measures

Name	Time	Method
Comet assay after single-dose consumption of Plantago asiatica L. extract	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

Secondary Outcome Measures

Name	Time	Method
Plasma erythrocyte SOD	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma triglyceride	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma ox-LDL	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma FRAP	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma FFA	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma MDA	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

Trial Locations

Locations (1)

Ewha Womans University / Hanaro Medical Foundation; 🇰🇷 Seoul, Korea, Republic of