UMIN-CTR Clinical Trial

Basic information
Public title	A study investigating the relationship between physical condition and the brain function in healthy adult males
Acronym	A study investigating the relationship between physical condition and the brain function in healthy adult males
Scientific Title	A study investigating the relationship between physical condition and the brain function in healthy adult males
Scientific Title:Acronym	A study investigating the relationship between physical condition and the brain function in healthy adult males
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relationships between changes in body temperature and the brain function in healthy adult males
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(Evaluation items) Changes in the result of Uchida Kraepelin test, Stroop test, and Paced Auditory Serial Addition Test (PASAT); changes in body temperature; changes in cerebral blood flow; changes in the result of subjective evaluation questionnaire by Visual Analog Scale (VAS)
Key secondary outcomes	(Exploratory evaluation items) Heart rate and heart rate variability, blood glucose level, hematocrit level, and serum osmolality (Safety evaluation) Frequency of adverse events during the study, general physical findings, and vital signs

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food Other
Interventions/Control_1	Maintenance of body temperature and intake of the test food
Interventions/Control_2	Maintenance of body temperature and intake of the control food
Interventions/Control_3	Thermal load to increase body temperature and intake of the test food
Interventions/Control_4	Thermal load to increase body temperature and intake of the control food
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	40 years-old >
Gender	Male
Key inclusion criteria	1) Subject who gave written consent for participation in the research 2) Healthy male 3) Age at the time of obtaining consent is 20 to 40 years old 4) Body mass index (BMI) is 18.5 or more and less than 25 (normal weight) 5) Subject who habitually eats breakfast for 4 days or more in a week 6) Subject who does not work in shifts or night shift 7) Right-handed subject 8) Subject who does not smoke 9) Subject who can carry out the test according to the schedule and procedure specified by the researcher
Key exclusion criteria	1) Subject who has collected 200 mL or more of whole blood within 4 weeks, or 400 mL or more of whole blood within 12 weeks, prior to the first blood collection 2) Subject whose clinical laboratory test values deviate from the normal range and are judged by the principal investigator to be ineligible for this study 3) Subject with any medical history of brain, nerve, psychiatry, circulatory system, endocrine function, or color vision deficiency who is judged by the principal investigator to be ineligible for this study 4) Subject whose rise in sublingual temperature is 1 degree Celsius or more, or less than 0.1 degree Celsius during the thermal load performed at a screening test 5) Subject whose total number of correct answers in Kraepelin test conducted at the screening test exceeds the average value plus-minus 2SD 6) Subject who cannot drink the specified amount of the test food 7) Subject who has used health foods or drugs and the principal investigator has determined that the usage affect the evaluation of the outcomes 8) Subject who is estimated inappropriate to this study by principal investigators
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Miyamoto
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Saga Nutraceuticals Research Institute
Zip code	842-0195
Address	5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga 842-0195, Japan
TEL	0952-52-1522
Email	Miyamoto.Shingo@otsuka.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014, Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committees of Yoga Allergy Clinic
Address	4-32-16 Yoga, Setagaya-ku, Tokyo 158-0097, Japan
Tel	03-5491-4478
Email	info@yg-allergy.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

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 26 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
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	2021 Year 01 Month 08 Day
Date of IRB	2021 Year 01 Month 15 Day
Anticipated trial start date	2021 Year 01 Month 16 Day
Last follow-up date	2021 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Ethics Committees of Yoga Allergy Clinic took over the IRB review process owing to the closing of Ethics Committees of Nihonbashi Egawa Clinic. The research was reviewed and approved by the new IRB on Feb 12th, 2021.

Management information
Registered date	2021 Year 01 Month 12 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049029