Antioxidative Effect of Plantago Asiatica L. Extract

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2011

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: • Plantago asiatica L. extract 5g
  • Experimental: Plantago asiatica L. extract 10g
  • Experimental: Plantago asiatica L. extract 20g
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary 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)

Secondary Measures

  • Plasma FRAP
    • Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
  • Plasma MDA
    • Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
  • Plasma FFA
    • Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
  • Plasma ox-LDL
    • Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
  • Plasma erythrocyte SOD
    • Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
  • Plasma triglyceride
    • Time Frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ewha Womans University
  • Collaborator
    • Ministry for Food, Agriculture, Forestry and Fisheries, Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Oran Kwon, Ph.D, Professor – Ewha Womans University
  • Overall Official(s)
    • Oran Kwon, Ph.D, Principal Investigator, Ewha Womans University

References

Sun Y. Free radicals, antioxidant enzymes, and carcinogenesis. Free Radic Biol Med. 1990;8(6):583-99. doi: 10.1016/0891-5849(90)90156-d.

Liu X, Wu X, Huang H, Zhong S, Lai X, Cao L. [Herbalogical study on Plantago asiatica L]. Zhong Yao Cai. 2002 Jan;25(1):46-8. Chinese.

Choi SY, Jung SH, Lee HS, Park KW, Yun BS, Lee KW. Glycation inhibitory activity and the identification of an active compound in Plantago asiatica extract. Phytother Res. 2008 Mar;22(3):323-9. doi: 10.1002/ptr.2316.

Chung MJ, Park KW, Kim KH, Kim CT, Baek JP, Bang KH, Choi YM, Lee SJ. Asian plantain (Plantago asiatica) essential oils suppress 3-hydroxy-3-methyl-glutaryl-co-enzyme A reductase expression in vitro and in vivo and show hypocholesterolaemic properties in mice. Br J Nutr. 2008 Jan;99(1):67-75. doi: 10.1017/S0007114507798926. Epub 2007 Aug 15.

Xu C, Luo L, Tan RX. Antidepressant effect of three traditional Chinese medicines in the learned helplessness model. J Ethnopharmacol. 2004 Apr;91(2-3):345-9. doi: 10.1016/j.jep.2004.01.012.

Lee SJ. Korean folk medicine. Publishing center of Seoul National Unicersity, Seoul. P 130, 1966

Jeong CH, Bae YI, Shim KH, Choi JS. DPPH radical scavenging effect and antimicrobial activities of Plantain (Plantago asiatica L.) extracts. J Korean Soc Food Sci Nutr 33(10): 1601-1605, 2004

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.