UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effects of test food on autonomic nerve activity: a randomized, double-blind, placebo-controlled, crossover trial
Acronym	A study to evaluate the effects of test food on autonomic nerve activity
Scientific Title	A study to evaluate the effects of test food on autonomic nerve activity: a randomized, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym	A study to evaluate the effects of test food on autonomic nerve activity
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 test food on autonomic nerve activity in healthy subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Heart rate variability
Key secondary outcomes	Neuropsychological tests for cognitive functions Visual Analogue Scale (VAS) of fatigue

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Period I. the test food Period II. control food * The intervention sequence is Period I to II. * Washout period is for approximately 1 week.
Interventions/Control_2	Period I. control food Period II. the test food * The intervention sequence is Period I to II. * Washout period is for approximately 1 week.
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	30 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Subjects who use Japanese as his/her primary language 2.Subjects who are judged as healthy by the physician from screening (scr) test
Key exclusion criteria	Subjects who 1. cannot identify color 2. have difficulty taking cognitive function tests because of weak sight or hearing 3. have 26 scores or less of MMSE 4. have a symptom, have been diagnosed, have a history, and/or have a daily medication for the following items: amblyopia, blindness, deafness, anacusis, cerebral nervous disease, cardiac disorder, depressive symptoms, depression, menopausal syndrome, sleep-related diseases, cardiac arrhythmia, and/or serious disease 5. are receiving hormonal therapy, or treatment related to cognitive function 6. have a pacemaker 7. sometimes have irregular lifestyles during study 8. have the following situation more than once a week: [taking drugs, or health foods that influence cognitive function, autonomic nerve activity, or improving sleep], or [taking foods resembling test food or energy drink] 9. having a habit of drinking beverages relating test foods more than once a month, regardless of amount, or cannot abstain from drinking the beverages between 1 week before scr test and the end of the test period 10. regularly drink alcohol beyond proper quantity 11. are smokers, or started smoking cessation within the last 12 months before scr 12. have experienced cognitive function tests within the last 12 months before scr 13. have donated whole blood or got a blood transfusion within the last 3 months before scr 14. have been enrolled in other clinical trials within the last 1 month before scr, or planning to participate during the test period 15. have a risk of allergies to the test food 16. are pregnant or lactation 17. are judged inappropriate as subjects from answers to lifestyle questionnaires 18. are not successfully taken his/her data of autonomic nerve activity at scr 19. or whose family who living together work at a company developing and manufacturing functional foods 20. plan to do the following during the test period: go abroad, donate blood, pregnant or lactation 21. are judged as unsuitable by doctor
Target sample size	30

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	Kirin Holdings Company, Limited
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	info@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)

Other administrative information
Date of disclosure of the study information	2020 Year 09 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	34
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	2019 Year 09 Month 09 Day
Date of IRB	2019 Year 09 Month 09 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2019 Year 12 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 27 Day
Last modified on	2020 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043463