Antioxidative Effect of Plantago Asiatica L. Extract

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

Detailed Description
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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.

Official Title
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Acute Effect of Plantago Asiatica L. Extract on Antioxidative Biomarkers in Subjects With Mild Hyperlipidemia: A Pilot Study

Conditions
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Oxidative Stress

Intervention / Treatment
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* Dietary Supplement: Plantago asiatica L. extract 5g
* Dietary Supplement: Plantago asiatica L. extract 10g
* Dietary Supplement: Plantago asiatica L. extract 20g
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: • Plantago asiatica L. extract 5g<br> | Dietary Supplement: Plantago asiatica L. extract 5g<br>* Liquid (80g) containing Plantago asiatica L. extract 5g<br>|
| Experimental: Plantago asiatica L. extract 10g<br> | Dietary Supplement: Plantago asiatica L. extract 10g<br>* Liquid (80g) containing Plantago asiatica L. extract 10g<br>|
| Experimental: Plantago asiatica L. extract 20g<br> | Dietary Supplement: Plantago asiatica L. extract 20g<br>* Liquid (80g) containing Plantago asiatica L. extract 20g<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Liquid (80g) without Plantago asiatica L. extract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma FRAP |  | 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) | 
| Plasma FFA |  | 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 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) |