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Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01594086
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
University of Shizuoka

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Dietary Supplement: green tea powder Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction in Elderly: An Exploratory Clinical Study
Study Start Date : May 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: green tea powder
Natural green tea powder
 Dietary Supplement: green tea powder
Consuming 2 g/day of green tea powder in three times divided for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the serum homocysteine levels [ Time Frame: between baseline and 3 months after ]
    Changes in the serum homocysteine levels before and after the intervention


Secondary Outcome Measures :
  1. Changes in serum lipid levels [ Time Frame: between baseline and 3 months after ]
    Changes in serum lipid levels before and after the intervention

  2. Changes in serum folic acid levels [ Time Frame: between baseline and 3 months after ]
    Changes in serum folic acid levels before and after the intervention

  3. Changes in mini mental state examination (MMSE) scores [ Time Frame: between baseline and 3 months after ]
    Changes in mini mental state examination (MMSE) scores before and after the intervention


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594086


Locations
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Japan
White Cross Nursing Home
Higashimurayama, Tokyo, Japan, 189-0021
Sponsors and Collaborators
University of Shizuoka
Investigators
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Study Chair: Yamada, Hiroshi University of Shizuoka
More Information
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Responsible Party: University of Shizuoka
ClinicalTrials.gov Identifier: NCT01594086    
Other Study ID Numbers: CT201201
24220501 ( Other Identifier: Ministry of Health, Labor and Welfare )
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013
Keywords provided by University of Shizuoka:
green tea
aging
atherosclerosis
homocysteine
cognitive impairment
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders