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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023391
Receipt No. R000026602
Scientific Title Investigation of the effects of the vegetable oils - containing supplement on cognitive functions in a healthy population: a double-blind, randomized placebo-controlled and parallel study
Date of disclosure of the study information 2018/03/30
Last modified on 2019/03/01

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Basic information
Public title Investigation of the effects of the vegetable oils - containing supplement on cognitive functions in a healthy population: a double-blind, randomized placebo-controlled and parallel study
Acronym Investigation of the effects of the vegetable oils - containing supplement on cognitive functions
Scientific Title Investigation of the effects of the vegetable oils - containing supplement on cognitive functions in a healthy population: a double-blind, randomized placebo-controlled and parallel study
Scientific Title:Acronym Investigation of the effects of the vegetable oils - containing supplement on cognitive functions
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the test food to improve cognition in healthy adults
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitrax,
Alzheimer's Disesase Assessment Scale-cognitive component -Japanese version
Key secondary outcomes Safety evaluation,
Oxidative stress markers in Blood,
Brain-derived neurotrophic factor in Blood

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of Test food (12 weeks)
Interventions/Control_2 Intake of Placebo (12 weeks)
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Subjects aged from 50 to 79 years old
2) Diagnosis by the principal investigator: mild cognitive impairment
3) Subjects should have an adequate understanding of the objectives and details of this study and the ability to give written informed consent for participation in the study by themselves
Key exclusion criteria 1) Individuals who take anti-dementia drugs
2) Individuals who take health foods relating cognitive function
3) Individuals judged as dementia for the results of HDS-R by the investigator
4) Individuals judged as depression for the results of GDS-S-J by the investigator
5) Individuals having difficulty in color vision
6) Individuals having difficulty in handling for a injury or operation etc.
7) Individuals who took part in another clinical study (intake of a supplemental food or medicine or composition applied to the skin) within 1 month prior to the start of the present study or who are currently taking part in another clinical study or who are willing to take part in another clinical study.
8) Individuals judged inappropriate for the study by the principal investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Asada
Organization Memory clinic Ochanomizu
Division name Memory clinic Ochanomizu
Zip code
Address 1-5-34 Yushima, Bunkyou-ku, Tokyo
TEL 03-6801-8718
Email asada@memory-cl.jp

Public contact
Name of contact person
1st name
Middle name
Last name FUJIFILM Corporation
Organization FUJIFILM Corporation
Division name Pharmaceutical & Healthcare Research Laboratories
Zip code
Address 2-5-1, Suwa, Tama-shi, Tokyo
TEL 080-2119-4836
Homepage URL
Email Hitomi.saito@fujifilm.com

Sponsor
Institute Memory clinic Ochanomizu
Institute
Department

Funding Source
Organization FUJIFILM Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://content.iospress.com/articles/journal-of-alzheimers-disease/jad170969
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
2016 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 29 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026602

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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