UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034059 |
|---|---|
| Receipt number | R000038820 |
| Scientific Title | Effect of the supplement on associative memory in cognitively intact older adults - A randomized, double-blind, placebo-controlled, parallel-group clinical trial- |
| Date of disclosure of the study information | 2018/09/07 |
| Last modified on | 2019/03/12 09:35:29 |
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Basic information
Public title
Effect of the supplement on associative memory in cognitively intact older adults - A randomized, double-blind, placebo-controlled, parallel-group clinical trial-
Acronym
Enhancement effect of the supplement containing ginkgo biloba extract on associative memory and brain activation
Scientific Title
Effect of the supplement on associative memory in cognitively intact older adults - A randomized, double-blind, placebo-controlled, parallel-group clinical trial-
Scientific Title:Acronym
Enhancement effect of the supplement containing ginkgo biloba extract on associative memory and brain activation
Region
| Japan |
Condition
Condition
Cognitively intact older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the enhancement effect of the supplement on the associative memory and brain activation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
-Hemoglobin oxygenation state in the brain
-Behavioral data (accuracy, error rate, response time)
Key secondary outcomes
-Attentional task score (1)
-Attentional task score (2)
-Questionnaire score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food (Administration period: 180days)
Interventions/Control_2
Control food (Administration period: 180days)
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females 60 to 74 years of age
2. Right handed
Key exclusion criteria
1.Smoker
2.Who is using the heart pacemaker
3.Who has records of any of the below:autonomic nervous system disease (autonomic imbalance, Meniere syndrome), brain disease, depression, bipolar depression and mood disorder
4.Who is taking medicine, Chinese medicine or supplements for brain function or brain blood flow improvement.
5.Who has dermatosis on head.
6.Who has records of any of the below:cerebral hemorrhage, subarachnoid hemorrhage, cardiac hypertrophy, cardiac decompensation, ischemic heart disease, nephrosclerosis, Aortic dissection, brain infarction.
7.Who had brain damage and hospitalized or had an operation within the past 10 years.
8.High blood pressure, hyperlipidemia, diabetes, hepatopathy, kidney disease, malignant tumor.
9.Who is participating other study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | YUI |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3532
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Kao |
| Middle name | |
| Last name | YAMAOKA |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3965
Homepage URL
kao1512@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
2-27-17 Minami-Ikenbukuro, Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr.info@jccr.jp
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
医療法人社団 知正会 東京センタークリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 07 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038820
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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