Antioxidative Effect of Plantago Asiatica L. Extract

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278589
• Other study ID #: PLA_Biofood
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: October 27, 2011
• Start date: December 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Dietary Supplement:
• Plantago asiatica L. extract 5g
Liquid (80g) containing Plantago asiatica L. extract 5g
• Plantago asiatica L. extract 10g
Liquid (80g) containing Plantago asiatica L. extract 10g
• Plantago asiatica L. extract 20g
Liquid (80g) containing Plantago asiatica L. extract 20g
• Placebo
Liquid (80g) without Plantago asiatica L. extract

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University / Hanaro Medical Foundation	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Ewha Womans University	Ministry for Food, Agriculture, Forestry and Fisheries, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

Sun Y. Free radicals, antioxidant enzymes, and carcinogenesis. Free Radic Biol Med. 1990;8(6):583-99. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comet assay after single-dose consumption of Plantago asiatica L. extract		measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)	No
Secondary	Plasma FRAP		measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)	No
Secondary	Plasma MDA		measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)	No
Secondary	Plasma FFA		measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)	No
Secondary	Plasma ox-LDL		measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)	No
Secondary	Plasma erythrocyte SOD		measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)	No
Secondary	Plasma triglyceride		measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)	No