UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011668 |
|---|---|
| Receipt number | R000013121 |
| Scientific Title | Effects of green tea consumption on cognitive dysfunction and atherosclerosis: A randomized-controlled study |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2017/09/10 10:42:33 |
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Basic information
Public title
Effects of green tea consumption on cognitive dysfunction and atherosclerosis: A randomized-controlled study
Acronym
Effects of green tea consumption on cognitive dysfunction and atherosclerosis
Scientific Title
Effects of green tea consumption on cognitive dysfunction and atherosclerosis: A randomized-controlled study
Scientific Title:Acronym
Effects of green tea consumption on cognitive dysfunction and atherosclerosis
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of green tea consumption on cognitive dysfunction
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of green tea consumption on the arteriosclerosis markers.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in Mini-Mental State Examination (MMSE) scores
Key secondary outcomes
Changes in sub-scores of MMSE
Changes in BMI, blood pressure, serum lipids, plasma glucose, HbA1c
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
green tea powder
Interventions/Control_2
placebo powder
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Obtained written informed consent from both the participant and care-giver before participation
2.Possible to consume green tea and placebo powder
3.Cognitive dysfunction based on MMSE; score < 28
4.Not taking any supplement possessing anti-oxidizing effects
Key exclusion criteria
1. Allergy to green tea
2. Severe cardiac, respiratory, renal, or hepatic dysfunction
3. Severe anemia
4. Diagnosed as inadequate to participate to the study by a doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
+81-54-264-5762
hyamada@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
+81-54-264-5762
Homepage URL
http://u-shizuoka-ken.ac.jp
hyamada@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Central Research Institute, ITO EN, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
White Cross Nursing Home
Name of secondary funder(s)
Japanese Ministry of Health, Labor, and Welfare
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
静岡県立大学（静岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 06 | Day |
Last modified on
| 2017 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013121
