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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Ewha Womans University / Hanaro Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; Liquid (80g) without Plantago asiatica L. extract
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comet assay after single-dose consumption of Plantago asiatica L. extract	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma FRAP	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)
Plasma FFA	measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
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)

Collaborators and Investigators

• Sponsor: Ewha Womans University
• Collaborators: Ministry for Food, Agriculture, Forestry and Fisheries, Korea

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (ESTIMATE): January 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 28, 2011
• Last Update Submitted That Met QC Criteria: October 27, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: PLA_Biofood