Antioxidative Effect of Plantago Asiatica L. Extract

This study has been completed.
Sponsor:
Collaborator:
Ministry for Food, Agriculture, Forestry and Fisheries, Korea
Information provided by (Responsible Party):
Oran Kwon, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01278589
First received: January 18, 2011
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma FRAP [ Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes) ] [ Designated as safety issue: No ]
  • Plasma MDA [ Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes) ] [ Designated as safety issue: No ]
  • Plasma FFA [ Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes) ] [ Designated as safety issue: No ]
  • Plasma ox-LDL [ Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes) ] [ Designated as safety issue: No ]
  • Plasma erythrocyte SOD [ Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes) ] [ Designated as safety issue: No ]
  • Plasma triglyceride [ Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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