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Completed

NCT Number: NCT01278589

Antioxidative Effect of Plantago Asiatica L. Extract

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

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Key information

Conditions

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Womans University / Hanaro Medical Foundation

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plantago asiatica L. extract 5g

Dietary Supplement

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

Plantago asiatica L. extract 10g

Dietary Supplement

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

Plantago asiatica L. extract 20g

Dietary Supplement

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

Placebo

Dietary Supplement

Liquid (80g) without Plantago asiatica L. extract

Primary outcomes

  1. Comet assay after single-dose consumption of Plantago asiatica L. extract

    Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

Secondary outcomes

  1. Plasma FRAP

    Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

  2. Plasma MDA

    Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

  3. Plasma FFA

    Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

  4. Plasma ox-LDL

    Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

  5. Plasma erythrocyte SOD

    Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

  6. Plasma triglyceride

    Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Collaborators

  • Ministry for Food, Agriculture, Forestry and Fisheries, Korea

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 19, 2011
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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