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Completed

NCT Number: NCT00448513

Effects of Tea Catechin Extracts on Oxidative Damage

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

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Key information

Conditions

Healthy

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shizuoka General Hospital

Shizuoka, 420-0881, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

catechin extracts

Dietary Supplement

comparison with placebo

Primary outcomes

  1. the frequency changes of micronuclei in peripheral lymphocytes

    Time frame: 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

    Time frame: After seven days intervention

Sponsors and collaborators

Lead sponsor

University of Shizuoka

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Mar 19, 2007
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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