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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

January 18, 2011
October 27, 2011
December 2010
April 2011   (final data collection date for primary outcome measure)
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 ]
Plasma FRAP, TAS, MDA, FFA, ox-LDL, erythrocyte SOD, CAP-e, Comet assay after single-dose consumption of Plantago asiatica L. extract [ Time Frame: measured 7 times over 6 hours(0, 60, 120, 180, 240, 300, 360 minutes) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01278589 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Oxidative Stress
  • Dietary Supplement: Plantago asiatica L. extract 5g
    Liquid (80g) containing Plantago asiatica L. extract 5g
  • Dietary Supplement: Plantago asiatica L. extract 10g
    Liquid (80g) containing Plantago asiatica L. extract 10g
  • Dietary Supplement: Plantago asiatica L. extract 20g
    Liquid (80g) containing Plantago asiatica L. extract 20g
  • Dietary Supplement: Placebo
    Liquid (80g) without Plantago asiatica L. extract
  • Experimental: • Plantago asiatica L. extract 5g
    Intervention: Dietary Supplement: Plantago asiatica L. extract 5g
  • Experimental: Plantago asiatica L. extract 10g
    Intervention: Dietary Supplement: Plantago asiatica L. extract 10g
  • Experimental: Plantago asiatica L. extract 20g
    Intervention: Dietary Supplement: Plantago asiatica L. extract 20g
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01278589
PLA_Biofood
No
Oran Kwon, Ewha Womans University
Ewha Womans University
Ministry for Food, Agriculture, Forestry and Fisheries, Korea
Principal Investigator: Oran Kwon, Ph.D Ewha Womans University
Ewha Womans University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP