Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Shizuoka
ClinicalTrials.gov Identifier:
NCT01594086
First received: May 1, 2012
Last updated: July 14, 2013
Last verified: July 2013
  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:


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
Study Completion Date: July 2013
Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594086

Locations
Japan
White Cross Nursing Home
Higashimurayama, Tokyo, Japan, 189-0021
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: July 14, 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 August 28, 2014