Effects of Tea Catechin Extracts on Oxidative Damage

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448513
• Other study ID #: CT2006005
• Status: Completed
• Phase: N/A
• First received: March 16, 2007
• Last updated: July 14, 2013
• Start date: June 2007
• Est. completion date: April 2012

Study information

• Verified date: April 2009
• Source: University of Shizuoka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2012
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• catechin extracts
comparison with placebo

Locations

Country	Name	City	State
Japan	Shizuoka General Hospital	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
University of Shizuoka

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the frequency changes of micronuclei in peripheral lymphocytes		After seven days untervention	Yes
Secondary	the change of markers of oxidative damage, as measured by 8-hydroxyguanosine (8-OHdG), vitamin C, folate, homocysteine		After seven days intervention	Yes