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Antioxidative Effect of Plantago Asiatica L. Extract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01278589
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : October 28, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Oxidative Stress Dietary Supplement: Plantago asiatica L. extract 5g Dietary Supplement: Plantago asiatica L. extract 10g Dietary Supplement: Plantago asiatica L. extract 20g Dietary Supplement: Placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Acute Effect of Plantago Asiatica L. Extract on Antioxidative Biomarkers in Subjects With Mild Hyperlipidemia: A Pilot Study
Study Start Date : December 2010
Primary Completion Date : April 2011
Study Completion Date : September 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: • Plantago asiatica L. extract 5g Dietary Supplement: Plantago asiatica L. extract 5g
Liquid (80g) containing Plantago asiatica L. extract 5g
Experimental: Plantago asiatica L. extract 10g Dietary Supplement: Plantago asiatica L. extract 10g
Liquid (80g) containing Plantago asiatica L. extract 10g
Experimental: Plantago asiatica L. extract 20g Dietary Supplement: Plantago asiatica L. extract 20g
Liquid (80g) containing Plantago asiatica L. extract 20g
Placebo Comparator: Placebo Dietary Supplement: Placebo
Liquid (80g) without Plantago asiatica L. extract


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278589


Locations
Korea, Republic of
Ewha Womans University / Hanaro Medical Foundation
Seoul, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University
Ministry for Food, Agriculture, Forestry and Fisheries, Korea
Investigators
Principal Investigator: Oran Kwon, Ph.D Ewha Womans University
More Information

Publications:
Responsible Party: Oran Kwon, Ph.D, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01278589     History of Changes
Other Study ID Numbers: PLA_Biofood
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: October 2011