UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on the cognitive function in healthy Japanese subjects
Acronym	Effects of consumption of the test food on the cognitive function in healthy Japanese subjects
Scientific Title	Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym	Effects of consumption of the test food on the cognitive function in 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 efficacy and safety of test food consumption for 12 weeks on the cognitive function in healthy Japanese subjects aged 40 or more
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Efficacy Outcome 1-1. The measured value of the standardized score of composite memory at 12 weeks after consumption (12w)
Key secondary outcomes	1. Efficacy Outcomes 1-1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) and 12w 1-2. The measured value of the standardized scores of each cognitive domain {neurocognition index (NCI), verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed} at four weeks after consumption (4w) and 12w 1-3. The amount of change of the standardized score of each cognitive domain from Scr to 4w and 12w 1-4. The measured values of each of the items of an original qustionaires at 4w and 12w 2. Safety Outcomes 2-1. Incidence of side effects 2-2. Incidence of adverse events 2-3. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at Scr 2-4. Physical measurement 2-5. Urinalysis 2-6. Blood test

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test food: Drink containing beta-hydroxybutyric acid (BHB) (BHB 16.0 g/day) Administration: Drink four bottles after breakfast and four bottles before going to bed * Daily dose should be taken within the day. 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 food: Drink containing BHB (BHB 12.0 g/day) Administration: Drink each four bottles after breakfast and four bottles before going to bed * Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_3	Duration: 12 weeks Test food: Drink not containing BHB Administration: Drink four bottles after breakfast and four bottles before going to bed * Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese 2. Men or women 3. Subjects aged 40 or more 4. Healthy subjects 5. Subjects who are aware of the decline in their memory function 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have 24 points or more of MMSE (Mini Mental State Examination) 8. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory 9. Subjects who have a relatively low standardized score in composite memory by Cognitrax
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who 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 take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 7. Subjects who take supplements or foods that may be 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 use 8. Subjects who take blue-backed fish such as sardines, mackerel, and saury at least four times a week 9. Subjects who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) in daily 10. Subjects currently taking medicines (include herbal medicines) and supplements 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, breast-feeding, and planning to become pregnant 13. Subjects who suffer from COVID-19 14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 15. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Takara
Organization	Medical Corporation Seishinkai, Takara Clinic
Division name	Director
Zip code	141-0022
Address	9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL	03-5793-3623
Email	t-takara@takara-clinic.com

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	OSAKA GAS CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi 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	2021 Year 10 Month 20 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	33
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	Terminated
Date of protocol fixation	2021 Year 10 Month 13 Day
Date of IRB	2021 Year 10 Month 13 Day
Anticipated trial start date	2021 Year 10 Month 22 Day
Last follow-up date	2022 Year 03 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 19 Day
Last modified on	2022 Year 07 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052283