UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034059
Receipt No. 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

* 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 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
Email 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
Email kao1512@fancl.co.jp

Sponsor
Institute FANCL Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038820

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.