Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction

NCT ID: NCT01594086

Last Updated: 2013-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-07-31

Brief Summary

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Green tea contains catechins and theanine as major ingredients and has been reported to have various beneficial influences on human health. It is reported that the drinking green tea is inversely associated with serum homocysteine level in elderly. However the effect of green tea consumption on cognitive dysfunction is not clinically clarified. The purpose of this study is to investigate the effects of green tea consumption on homocysteine metabolism and cognitive dysfunction in elderly with impaired cognitive function.

Detailed Description

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Elderly people with impaired cognitive function go on increasing year by year with the coming aged society. Among them, the Alzheimer disease is a major cause of the illness, which is progressively worse, has no fundamental curable therapy, and induces the burdens of caregivers as well as the health insurance and national budget. Recently, homocysteine metabolism is reported to be related to atherosclerosis in aging, and draw attention as the etiology of cognitive dysfunction in elderly.

Green tea contains catechins and theanine as main ingredients. These components are reported to have anti-atherogenic action and effect on improving cognitive dysfunction. However, clinical evidence for homocysteine metabolism and cognitive dysfunction has not been clarified. Therefore, in this study, the investigators attempted to investigate the effects of green tea consumption on homocysteine metabolism and cognitive dysfunction in elderly with impaired cognitive function.

Conditions

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Cognitive Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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green tea powder

Natural green tea powder

Group Type EXPERIMENTAL

green tea powder

Intervention Type DIETARY_SUPPLEMENT

Consuming 2 g/day of green tea powder in three times divided for 3 months

Interventions

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green tea powder

Consuming 2 g/day of green tea powder in three times divided for 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Obtained written informed consent before participation
* Possible to consume green tea powder
* Possessing cognitive dysfunction; MMSE score less than 30
* Possible not to take any supplement possessing anti-oxidizing effect; i.e., vitamin A, C, E, β-carotene

Exclusion Criteria

* Possessing allergy to green tea
* Possessing severe cardiac, respiratory, renal, or hepatic dysfunction
* Possessing severe anemia
* Diagnosed as inadequate to participate in the study by doctor
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Shizuoka

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yamada, Hiroshi

Role: STUDY_CHAIR

University of Shizuoka

Locations

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White Cross Nursing Home

Higashimurayama, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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24220501

Identifier Type: OTHER

Identifier Source: secondary_id

CT201201

Identifier Type: -

Identifier Source: org_study_id

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