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Clinical Trials/NCT01278589
NCT01278589
Completed
Not Applicable

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

Ewha Womans University1 site in 1 country40 target enrollmentStarted: December 2010Last updated:
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ConditionsOxidative Stress

Overview

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Comet assay after single-dose consumption of Plantago asiatica L. extract
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
All
Accepts 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
  • •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

Outcomes

Primary Outcomes

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

  • 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))
  • Plasma FRAP(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 MDA(measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Oran Kwon

Ph.D, Professor

Ewha Womans University

Study Sites (1)

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