- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594086
Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction
Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction in Elderly: An Exploratory Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tokyo
-
Higashimurayama, Tokyo, Japan, 189-0021
- White Cross Nursing Home
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: green tea powder
Natural green tea powder
|
Consuming 2 g/day of green tea powder in three times divided for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the serum homocysteine levels
Time Frame: between baseline and 3 months after
|
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
Time Frame: between baseline and 3 months after
|
Changes in serum lipid levels before and after the intervention
|
between baseline and 3 months after
|
Changes in serum folic acid levels
Time Frame: between baseline and 3 months after
|
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
Time Frame: between baseline and 3 months after
|
Changes in mini mental state examination (MMSE) scores before and after the intervention
|
between baseline and 3 months after
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yamada, Hiroshi, University of Shizuoka
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT201201
- 24220501 (Other Identifier: Ministry of Health, Labor and Welfare)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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