Antioxidative Effect of Plantago Asiatica L. Extract

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01278589

Enrollment

Registered

2011-01-19

Start date

2010-12-31

Completion date

2011-09-30

Last updated

2011-10-28

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

Conditions

Oxidative Stress

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.

Interventions

DIETARY_SUPPLEMENTPlantago asiatica L. extract 5g

Liquid (80g) containing Plantago asiatica L. extract 5g

DIETARY_SUPPLEMENTPlantago asiatica L. extract 10g

Liquid (80g) containing Plantago asiatica L. extract 10g

DIETARY_SUPPLEMENTPlantago asiatica L. extract 20g

Liquid (80g) containing Plantago asiatica L. extract 20g

DIETARY_SUPPLEMENTPlacebo

Liquid (80g) without Plantago asiatica L. extract

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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 FRAP	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)
Plasma ox-LDL	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026