Antioxidative Effect of Plantago Asiatica L. Extract

NCT01278589 | Completed

• 1 other identifier: PLA_Biofood
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (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 Outcomes (6)

• 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)

Study Arms (4)

• Plantago asiatica L. extract 5g

EXPERIMENTAL

Dietary Supplement: Plantago asiatica L. extract 5g

Plantago asiatica L. extract 10g

EXPERIMENTAL

Dietary Supplement: Plantago asiatica L. extract 10g

Plantago asiatica L. extract 20g

EXPERIMENTAL

Dietary Supplement: Plantago asiatica L. extract 20g

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Plantago asiatica L. extract 5g DIETARY_SUPPLEMENT

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

• Plantago asiatica L. extract 5g

Plantago asiatica L. extract 10g DIETARY_SUPPLEMENT

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

Plantago asiatica L. extract 10g

Plantago asiatica L. extract 20g DIETARY_SUPPLEMENT

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

Plantago asiatica L. extract 20g

Placebo DIETARY_SUPPLEMENT

Liquid (80g) without Plantago asiatica L. extract

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Ewha Womans University / Hanaro Medical Foundation

Seoul, South Korea

Location

Related Publications (7)

• 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.

  PMID: 2193855 BACKGROUND

• 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.

  PMID: 12583244 BACKGROUND

• 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.

  PMID: 18167045 BACKGROUND

• 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.

  PMID: 17697428 BACKGROUND

• 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.

  PMID: 15120459 BACKGROUND

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

  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

  BACKGROUND

Study Officials

• Oran Kwon, Ph.D

  Ewha Womans University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, Professor

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 28, 2011

Record last verified: 2011-10

Locations

KR (1)