UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000011668
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email hyamada@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013121


Contact us.