UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031757 |
|---|---|
| Receipt number | R000036256 |
| Scientific Title | The verification study of improvements in cognitive functions: A randomized double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2021/05/25 11:34:45 |
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Basic information
Public title
The verification study of improvements in cognitive functions: A randomized double-blind placebo-controlled trial
Acronym
The verification study of improvements in cognitive functions
Scientific Title
The verification study of improvements in cognitive functions: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym
The verification study of improvements in cognitive functions
Region
| Japan |
Condition
Condition
Healthy Japanese adult people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of improvements in cognitive function with the 12-week intake of test food
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite memory
* Assessed by Cognitrax
* Perform Cognitrax at screening and examination before consuming and at 8 and 12 weeks after ingestion
Key secondary outcomes
1. Neurocognitive index
2. Verbal memory
3. Visual memory
4. Psychomotor speed
5. Reaction time
6. Complex attention
7. Cognitive flexibility
8. Processing speed
9. Executive function
10. Social acuity
11. Reasoning
12. Working memory
13. Sustained attention
14. Simple attention
15. Motor speed
16. Subjective symptoms
17. Brain-derived neurotrophic factor (BDNF) concentration in blood
18. Propanoyl lysine (PRL) concentration in blood
19. Pentosidine concentration in blood
*1-15 Assessed by Cognitrax
*16 Assessed by Likert scale
*1-19 Perform the tests at screening and examination before consuming and at 8 and 12 weeks after ingestion
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test material: Capsule containing astaxanthin
Administration: Take one capsule during or after breakfast
* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
Duration: 12 weeks
Test material: Placebo
Administration: Take one capsule during or after breakfast
* If you forget to take the test food, take it as soon as you remember within the day.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adult people who are experiencing memory loss
2. Subjects who are judged as eligible to participate in the study by the physician
3. Meeting the 2nd criteria requirement, subjects who get 24 or more in score of Mini Mental State Examination (MMSE)
4. Meeting the 3nd criteria requirement, subjects who has relatively low standardized score in composite memory by Cognitrax
Key exclusion criteria
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disease, rheumatism, diabetes mellitus, dyslipidemia, hypertension or any other chronic diseases
3. Subjects who have dementia
4. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
5. Currently taking medications (include herbal medicines), "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage
6. Subjects who take supplements related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), and phosphatidylserine in daily
7. Subjects who are allergic to medicines and/or the test food related products
8. Subjects who are pregnant, lactation, and planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
BGG Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
44
Results
Sekikawa T, Kizawa Y, Li Y, Takara T. Cognitive Function Improvement with Astaxanthin Intake: A Randomized, Double-Blind, Placebo-Controlled Study. Pharmacometrics 2019; 97(1/2): 1-13
Results date posted
| 2021 | Year | 05 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 09 | Month | 26 | Day |
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
Undecided
IPD sharing Plan description
To require consultation among related companies
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 19 | 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
| 2018 | Year | 03 | Month | 16 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036256
