Antioxidative Effect of Plantago Asiatica L. Extract

NCT ID: NCT01278589

Last Updated: 2011-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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• Plantago asiatica L. extract 5g

Group Type EXPERIMENTAL

Plantago asiatica L. extract 5g

Intervention Type DIETARY_SUPPLEMENT

Liquid (80g) containing Plantago asiatica L. extract 5g

Plantago asiatica L. extract 10g

Group Type EXPERIMENTAL

Plantago asiatica L. extract 10g

Intervention Type DIETARY_SUPPLEMENT

Liquid (80g) containing Plantago asiatica L. extract 10g

Plantago asiatica L. extract 20g

Group Type EXPERIMENTAL

Plantago asiatica L. extract 20g

Intervention Type DIETARY_SUPPLEMENT

Liquid (80g) containing Plantago asiatica L. extract 20g

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Liquid (80g) without Plantago asiatica L. extract

Interventions

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Plantago asiatica L. extract 5g

Liquid (80g) containing Plantago asiatica L. extract 5g

Intervention Type DIETARY_SUPPLEMENT

Plantago asiatica L. extract 10g

Liquid (80g) containing Plantago asiatica L. extract 10g

Intervention Type DIETARY_SUPPLEMENT

Plantago asiatica L. extract 20g

Liquid (80g) containing Plantago asiatica L. extract 20g

Intervention Type DIETARY_SUPPLEMENT

Placebo

Liquid (80g) without Plantago asiatica L. extract

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry for Food, Agriculture, Forestry and Fisheries, Korea

OTHER_GOV

Sponsor Role collaborator

Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Oran Kwon

Ph.D, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oran Kwon, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University

Locations

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Ewha Womans University / Hanaro Medical Foundation

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 2193855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12583244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18167045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17697428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15120459 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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PLA_Biofood

Identifier Type: -

Identifier Source: org_study_id