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Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction

Primary Purpose

Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
green tea powder
Sponsored by
University of Shizuoka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring green tea, aging, atherosclerosis, homocysteine, cognitive impairment

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • White Cross Nursing Home

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

green tea powder

Arm Description

Natural green tea powder

Outcomes

Primary Outcome Measures

Changes in the serum homocysteine levels
Changes in the serum homocysteine levels before and after the intervention

Secondary Outcome Measures

Changes in serum lipid levels
Changes in serum lipid levels before and after the intervention
Changes in serum folic acid levels
Changes in serum folic acid levels before and after the intervention
Changes in mini mental state examination (MMSE) scores
Changes in mini mental state examination (MMSE) scores before and after the intervention

Full Information

First Posted
May 1, 2012
Last Updated
July 14, 2013
Sponsor
University of Shizuoka
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1. Study Identification

Unique Protocol Identification Number
NCT01594086
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Shizuoka

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
green tea, aging, atherosclerosis, homocysteine, cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
green tea powder
Arm Type
Experimental
Arm Description
Natural green tea powder
Intervention Type
Dietary Supplement
Intervention Name(s)
green tea powder
Intervention Description
Consuming 2 g/day of green tea powder in three times divided for 3 months
Primary Outcome Measure Information:
Title
Changes in the serum homocysteine levels
Description
Changes in the serum homocysteine levels before and after the intervention
Time Frame
between baseline and 3 months after
Secondary Outcome Measure Information:
Title
Changes in serum lipid levels
Description
Changes in serum lipid levels before and after the intervention
Time Frame
between baseline and 3 months after
Title
Changes in serum folic acid levels
Description
Changes in serum folic acid levels before and after the intervention
Time Frame
between baseline and 3 months after
Title
Changes in mini mental state examination (MMSE) scores
Description
Changes in mini mental state examination (MMSE) scores before and after the intervention
Time Frame
between baseline and 3 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yamada, Hiroshi
Organizational Affiliation
University of Shizuoka
Official's Role
Study Chair
Facility Information:
Facility Name
White Cross Nursing Home
City
Higashimurayama
State/Province
Tokyo
ZIP/Postal Code
189-0021
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction

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