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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name