Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction
2 other identifiers
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 16, 2013
July 1, 2013
1.2 years
May 1, 2012
July 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in the serum homocysteine levels
Changes in the serum homocysteine levels before and after the intervention
between baseline and 3 months after
Secondary Outcomes (3)
Changes in serum lipid levels
between baseline and 3 months after
Changes in serum folic acid levels
between baseline and 3 months after
Changes in mini mental state examination (MMSE) scores
between baseline and 3 months after
Study Arms (1)
green tea powder
EXPERIMENTALNatural green tea powder
Interventions
Consuming 2 g/day of green tea powder in three times divided for 3 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
White Cross Nursing Home
Higashimurayama, Tokyo, 189-0021, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yamada, Hiroshi
University of Shizuoka
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2012
First Posted
May 8, 2012
Study Start
May 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 16, 2013
Record last verified: 2013-07