Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594086
• Other study ID #: CT201201
• Secondary ID: 24220501
• Status: Completed
• Phase: N/A
• First received: May 1, 2012
• Last updated: July 14, 2013
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of Shizuoka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

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, ß-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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment

Intervention

Dietary Supplement:
• green tea powder
Consuming 2 g/day of green tea powder in three times divided for 3 months

Locations

Country	Name	City	State
Japan	White Cross Nursing Home	Higashimurayama	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
University of Shizuoka

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the serum homocysteine levels	Changes in the serum homocysteine levels before and after the intervention	between baseline and 3 months after	No
Secondary	Changes in serum lipid levels	Changes in serum lipid levels before and after the intervention	between baseline and 3 months after	No
Secondary	Changes in serum folic acid levels	Changes in serum folic acid levels before and after the intervention	between baseline and 3 months after	No
Secondary	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	No