Effects of Tea Catechin Extracts on Oxidative Damage

July 14, 2013 updated by: University of Shizuoka

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Shizuoka, Japan, 420-0881
        • Shizuoka General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: catechin
catechin capsule group
Dietary supplement: catechin extracts
comparison with placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the frequency changes of micronuclei in peripheral lymphocytes
Time Frame: After seven days untervention
After seven days untervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Shizuoka

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Estimate)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 14, 2013

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CT2006005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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