UMIN-CTR Clinical Trial

Basic information
Public title	Validation research on body-temperature regulation by test-food intakes
Acronym	Validation research on body-temperature regulation by test-food intakes
Scientific Title	Validation research on body-temperature regulation by test-food intakes
Scientific Title:Acronym	Validation research on body-temperature regulation by test-food intakes
Region	Japan

Condition
Condition	Healthy male adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify some kind of improvement effect in body-temperature regulation by ingesting the test food to the subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changing rate of core-body temperature (drum temperature)
Key secondary outcomes	1. Body weight-changing rate 2. Plasma volume-changing rate 3. Total protein 4. Albumin 5. Serum sodium 6. Serum osmolality 7. Fractional excretion of sodium 8. Creatinine clearance 9. Free water clearance 10. Voided volume 11. Bloodstream (OMEGAZONE) 12. Heartbeat rate (Polar Unite) 13. Subjective symptoms based on a visual analog scale questionnaire (feebleness, thirst, hotness)

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Freely consumption of the test/placebo food (two bottles a day) to the subject for five days at home.
Interventions/Control_2	On admission, consumption of the test/placebo food (two bottles a day) to the subject at the appointed time.
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	65 years-old >
Gender	Male
Key inclusion criteria	(1) Healthy male subjects ranging in age from 20 to 64, at informed consent. (2) Subjects ranging in BMI from 18.5 to less than 25.0 kg/m2. (3) Subjects who can give informed consent to participate in this trial, after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects who have any difficulty in doing exercises with a bicycle ergometer for approximately 30 min. (2) Subjects falling into the habit of excessive alcohol intake. (3) Subjects who have the habit of smoking, at the present time and/or within a year before this trial. (4) Subjects with extremely irregular life rhythm. (5) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (6) Subjects being under some kind of continuous medical treatment, and/or planning to have it during this trial. (7) Subjects having drug and/or food allergy. (8) Subjects who are now under the other clinical tests with some kind of medicine/food, or took part in those within four weeks before this trial, or will join those after giving informed consent to participate in this trial. (9) Subjects who donated 400 mL of their whole blood within the last three months before this trial. (10) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Kazunori Middle name Last name Kato
Organization	Toyo University
Division name	Professor, Director of the center
Zip code	350-0815
Address	2100 Kujirai, Kawagoe, Saitama 350-0815, Japan
TEL	049-239-1397
Email	k-kato@toyo.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Clinical Planning Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	EZAKI GLICO 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.jp

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 04 Month 15 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 03 Month 23 Day
Date of IRB	2021 Year 03 Month 19 Day
Anticipated trial start date	2021 Year 04 Month 15 Day
Last follow-up date	2021 Year 06 Month 11 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 04 Month 13 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050103