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Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction

This study is currently recruiting participants.
Verified April 2012 by University of Shizuoka
Sponsor:
Information provided by (Responsible Party):
University of Shizuoka
ClinicalTrials.gov Identifier:
NCT01594086
First received: May 1, 2012
Last updated: January 8, 2013
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Cognitive Impairment
 Dietary Supplement: green tea powder

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction in Elderly: An Exploratory Clinical Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Shizuoka:

Primary Outcome Measures:
  • Changes in the serum homocysteine levels [ Time Frame: between baseline and 3 months after ] [ Designated as safety issue: No ]
    Changes in the serum homocysteine levels before and after the intervention


Secondary Outcome Measures:
  • Changes in serum lipid levels [ Time Frame: between baseline and 3 months after ] [ Designated as safety issue: No ]
    Changes in serum lipid levels before and after the intervention

  • Changes in serum folic acid levels [ Time Frame: between baseline and 3 months after ] [ Designated as safety issue: No ]
    Changes in serum folic acid levels before and after the intervention

  • Changes in mini mental state examination (MMSE) scores [ Time Frame: between baseline and 3 months after ] [ Designated as safety issue: No ]
    Changes in mini mental state examination (MMSE) scores before and after the intervention


Estimated Enrollment: 15
Study Start Date: May 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594086

Contacts
Contact: Hiroshi Yamada, MD, PhD +81 54 264 5762 hyamada@u-shizuoka-ken.ac.jp
Contact: Noriko Wakamiya +81 54 264 5770 m08129@u-shizuoka-ken.ac.jp

Locations
Japan
White Cross Nursing Home Recruiting
Higashimurayama, Tokyo, Japan, 189-0021
Contact: Norikata Takuma, MD, PhD     +81 42 392 1375        
Contact: Sadako Fujii            
Principal Investigator: Norikata Takuma, MD, PhD            
Sponsors and Collaborators
University of Shizuoka
Investigators
Study Chair: Yamada, Hiroshi University of Shizuoka
  More Information

No publications provided

Responsible Party: University of Shizuoka
ClinicalTrials.gov Identifier: NCT01594086     History of Changes
Other Study ID Numbers: CT201201, 24220501
Study First Received: May 1, 2012
Last Updated: January 8, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Shizuoka:
green tea
aging
atherosclerosis
homocysteine
cognitive impairment

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013