Antioxidative Effect of Plantago Asiatica L. Extract

• Sponsor: Ewha Womans University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01278589
• Collaborator: Ministry for Food, Agriculture, Forestry and Fisheries, Korea (Other)
• Enrollment: 40
• Location: 1
• Arms: 4
• Duration (Months): 9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress	Dietary Supplement: Plantago asiatica L. extract 5g; Dietary Supplement: Plantago asiatica L. extract 10g; Dietary Supplement: Plantago asiatica L. extract 20g; Dietary Supplement: Placebo	N/A

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
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• Official Title: Acute Effect of Plantago Asiatica L. Extract on Antioxidative Biomarkers in Subjects With Mild Hyperlipidemia: A Pilot Study
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo	Dietary Supplement: Placebo; Liquid (80g) without Plantago asiatica L. extract

Outcome Measures

Primary Outcome Measures

1. 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

1. Plasma FRAP [measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)]

2. Plasma MDA [measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)]

3. Plasma FFA [measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)]

4. Plasma ox-LDL [measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)]

5. Plasma erythrocyte SOD [measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)]

6. Plasma triglyceride [measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ewha Womans University / Hanaro Medical Foundation	Seoul		Korea, Republic of

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Oran Kwon, Ph.D, Ewha Womans University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Epub 2007 Aug 15.
• 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
• Lee SJ. Korean folk medicine. Publishing center of Seoul National Unicersity, Seoul. P 130, 1966
• 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.
• Sun Y. Free radicals, antioxidant enzymes, and carcinogenesis. Free Radic Biol Med. 1990;8(6):583-99. Review.
• 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.

• Responsible Party: Oran Kwon, Ph.D, Professor, Ewha Womans University
• ClinicalTrials.gov Identifier: NCT01278589
• Other Study ID Numbers: PLA_Biofood
• First Posted: Jan 19, 2011
• Last Update Posted: Oct 28, 2011
• Last Verified: Oct 1, 2011

Study Results

No Results Posted as of Oct 28, 2011