UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on cognitive function of healthy Japanese subjects
Acronym	Effects of consumption of the test food on cognitive function of healthy Japanese subjects
Scientific Title	Effects of consumption of the test food on cognitive function of healthy Japanese subjects: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym	Effects of consumption of the test food on cognitive function of healthy Japanese subjects
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of consumption of the test food on cognitive function in healthy Japanese subjects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The measured values of composite memory of Cognitrax at eight weeks after consumption
Key secondary outcomes	1. The amount of change for composite memory of Cognitrax between screening (before consumption) and eight weeks after consumption 2. The measured values of each item excluding composite memory of Cognitrax at eight weeks after consumption 3. The amount of change for each item excluding composite memory of Cognitrax between screening (before consumption) and eight weeks after consumption 4. The measured values of each score and question items of POMS2 at eight weeks after consumption 5. The amount of change for each score and question items of POMS2 between screening (before consumption) and eight weeks after consumption 6. The measured values of each factor and items of OSA-MA at eight weeks after consumption 7. The amount of change for each factor and items of OSA-MA between screening (before consumption) and eight weeks after consumption 8. The measured values of original questionnaires (The Likert scale method) at eight weeks after consumption

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: Eight weeks Test food: Supplements containing ginkgo leaf extract Administration: Take two capsules per day at breakfast with water *If you forget to take the test food, take it as soon as you remember within the day
Interventions/Control_2	Duration: Eight weeks Test food: Placebo Administration: Take two capsules per day at breakfast with water *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 subjects 2. Subjects who feel memory loss 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have 24 points or more of MMSE 5. 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. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Subjects who have dementia 5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 7. 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), phosphatidylserine, and plasmalogen in daily 8. Subjects who take blue-backed fish such as sardines, mackerel, and saury in daily 9. Currently taking medicines (include herbal medicines) and supplements 10. Subjects who are allergic to medicines and/or the test food related products 11. Subjects who are pregnant, breast-feeding, and plan to become a pregnant during the study period or in the future, or wish for their own child 12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 13. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
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 Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
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	YASOUKOUSO.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	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	IRB@takara-clinic.com

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) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 30 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	66
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	2020 Year 06 Month 23 Day
Date of IRB	2020 Year 06 Month 23 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2020 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 06 Month 29 Day
Last modified on	2021 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046746