Effects of Tea Catechin Extracts on Oxidative Damage - Full Text View

Purpose

The purpose of this study is to clarify the effects of tea catechin extracts on the frequency changes of micronuclei in peripheral lymphocytes compared with other oxidative stress markers in late middle aged healthy volunteers

Condition	Intervention
Healthy	Dietary Supplement: catechin extracts

MedlinePlus related topics:

Stress

Drug Information available for:

Epigallocatechin gallate Catechin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Effects of Tea Catechin Extracts on the Frequency Changes of Micronuclei in Peripheral Lymphocytes in Late Middle Aged Healthy Volunteers

Further study details as provided by University of Shizuoka:

Primary Outcome Measures:

the frequency changes of micronuclei in peripheral lymphocytes [ Time Frame: After seven days untervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

the change of markers of oxidative damage, as measured by 8-hydroxyguanosine (8-OHdG), vitamin C, folate, homocysteine [ Time Frame: After seven days intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

comparison with placebo

Detailed Description:

Experimental studies have revealed that tea catechin extracts induce preventive effects on oxidative stress, but there have been few clinical trials conducted to verify the effects. Also, there have been few clinical markers indicating oxidative damage, and therefore, more accurate and reliable markers have been expected. The study is designed for evaluating the effects of tea catechin extracts on the frequency changes of micronuclei in peripheral lymphocytes as the indicator of oxidative damage, compared with other oxidative stress markers in late middle aged healthy volunteers.

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

aged 40 to 65 years old
healthy volunteers
obtained written informed concent before participation

Exclusion Criteria:

participant who is not able to refrain from drinking tea for 2 weeks during the study
participant taking supplements or herbal products including folate, vitamin B, C, E, coenzyme Q10, calcium, for 2 weeks before the study
participant taking supplements or herbal products including folate, vitamin E for 3 months before the study
participant possessing tea allergy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448513

Contacts


Contact: Hiroshi Yamada, MD, PhD	-81 54 264 5762	hyamada@u-shizuoka-ken.ac.jp

Locations


Japan
	Shizuoka General Hospital	Recruiting
	Shizuoka, Japan, 420-0881
	Contact: Katsuhiko Matsuda, MD, PhD +81 54 247 6111
	Principal Investigator: Katsuhiko Matsuda, MD, PhD

Sponsors and Collaborators

University of Shizuoka

Investigators


Principal Investigator:	Hiroshi Yamada, MD, PhD	University of Shizuoka

More Information

Responsible Party:	University of Shizuoka ( Yamada H. Professor )
Study ID Numbers:	CT2006005
First Received:	March 16, 2007
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00448513
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Shizuoka:

catechin

oxidative stress

chromosome damage

aged

Study placed in the following topic categories:

Epigallocatechin gallate

Stress

Healthy

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	University of Shizuoka
Information provided by:	University of Shizuoka
ClinicalTrials.gov Identifier:	NCT00448513