Clinical trial NCT01594086: Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction
Official title: Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction in Elderly: An Exploratory Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: green tea
aging
atherosclerosis
homocysteine
cognitive impairment
Lead sponsor: University of Shizuoka
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Changes in the serum homocysteine levels
timeFrame: between baseline and 3 months after
Secondary outcomes:
measure: Changes in serum lipid levels
timeFrame: between baseline and 3 months after
measure: Changes in serum folic acid levels
timeFrame: between baseline and 3 months after
measure: Changes in mini mental state examination (MMSE) scores
timeFrame: between baseline and 3 months after
Other outcomes:
Locations:
city: Higashimurayama
country: Japan
facility: White Cross Nursing Home
state: Tokyo
Study officials:
affiliation: University of Shizuoka
name: Yamada, Hiroshi
role: STUDY_CHAIR
References: