NCT00448513

Completed

Effects of Tea Catechin Extracts on Oxidative Damage

University of Shizuoka Source

Other study identifiers

Sponsor study identifier

CT2006005

Study Type

interventional

Actual enrollment (reported)

40

Locations

1 country

Sites

1

Timeline

Study Start

June 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2009

Actual (reported)

Study Completion

April 2012

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 40 participants
Study completion date: April 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 16, 2007
Actual (reported)
First Posted
March 19, 2007
Actual (reported)
Study Start
June 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)
Study Completion
April 2012
Actual (reported)

Last Updated: July 16, 2013
Status Verified: April 2009
Last Update Submitted: July 14, 2013

Conditions

Healthy

Keywords

catechinoxidative stresschromosome damageaged

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (1)

catechin

EXPERIMENTAL

catechin capsule group

Dietary Supplement: catechin extracts

Interventions

catechin extractsDietary supplement

comparison with placebo

catechin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

aged 40 to 65 years old
healthy volunteers

Sponsors & Collaborators

University of Shizuoka
Otherlead

Study Sites (1)

Shizuoka General Hospital

Shizuoka, Shizuoka, 420-0881, Japan

Study Officials

Hiroshi Yamada, MD, PhD
University of Shizuoka
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 16, 2007

First Posted

March 19, 2007

Study Start

June 2007

Date type not reported

This date has not been verified as actual or estimated.

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obtained written informed concent before participation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

August 2009

Actual (reported)

Study Completion

April 2012

Actual (reported)

Last Updated

July 16, 2013

Record last verified: 2009-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00448513
Data provider: ClinicalTrials.gov
Source updated: 2013-07-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:14 UTC

Locations

JP(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

catechin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations