Effects of Tea Catechin Extracts on Oxidative Damage

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: catechin extracts

• Registration Number: NCT00448513
• Lead Sponsor: University of Shizuoka

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-03-16
• Study First Submitted QC: 2007-03-16
• Study First Posted: 2007-03-19
• Study Start: 2007-06
• Status Verified: 2009-04
• Primary Completion: 2009-08
• Study Completion: 2012-04
• Last Update Submitted: 2013-07-14
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
catechin	catechin extracts	catechin capsule group

Primary Outcome Measures

Name	Time	Method
the frequency changes of micronuclei in peripheral lymphocytes	After seven days untervention

Secondary Outcome Measures

Name	Time	Method
the change of markers of oxidative damage, as measured by 8-hydroxyguanosine (8-OHdG), vitamin C, folate, homocysteine	After seven days intervention

Trial Locations

Locations (1)

Shizuoka General Hospital; 🇯🇵 Shizuoka, Japan