Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction

Study Overview
=================
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.

Official Title
-----------------
Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction in Elderly: An Exploratory Clinical Study

Conditions
-----------------
Cognitive Impairment

Intervention / Treatment
-----------------
* Dietary Supplement: green tea powder


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: green tea powder<br>Natural green tea powder | Dietary Supplement: green tea powder<br>* Consuming 2 g/day of green tea powder in three times divided for 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the serum homocysteine levels | Changes in the serum homocysteine levels before and after the intervention | between baseline and 3 months after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum lipid levels | Changes in serum lipid levels before and after the intervention | between baseline and 3 months after | 
| Changes in serum folic acid levels | Changes in serum folic acid levels before and after the intervention | between baseline and 3 months after | 
| Changes in mini mental state examination (MMSE) scores | Changes in mini mental state examination (MMSE) scores before and after the intervention | between baseline and 3 months after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
green tea, aging, atherosclerosis, homocysteine, cognitive impairment