UMIN-CTR Clinical Trial

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	Unpublished
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/jcbn/67/3/67_19-116/_article
Number of participants that the trial has enrolled	44
Results	Sekikawa T, Kizawa Y, Li Y, Takara T. Cognitive function improvement with astaxanthin and tocotrienol intake: a randomized, double-blind, placebo-controlled study. J Clin Biochem Nutr 2020; 67(3): 307-316
Results date posted	2021 Year 05 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 06 Month 19 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036257