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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031758
Receipt No. R000036257
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 2019/02/08

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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 and tocotrienol
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, 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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
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 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
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 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
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036257

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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