UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023391 |
|---|---|
| Receipt number | 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 17:18:01 |
* 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
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
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
Hitomi.saito@fujifilm.com
Sponsor or person
Institute
Memory clinic Ochanomizu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026602
