UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of test food (HBF 2018-04) on human body temperature: Parallel study
Acronym	The Effect of test food (HBF 2018-04) on human body temperature.
Scientific Title	The Effect of test food (HBF 2018-04) on human body temperature: Parallel study
Scientific Title:Acronym	The Effect of test food (HBF 2018-04) on human body temperature.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the test food on body temperature
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Body temperature
Key secondary outcomes	1. Questionnaire survey on the physical condition 2. Body composition

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Oral ingestion of the test food once a day for 30 weeks
Interventions/Control_2	Oral ingestion of the placebo food once a day for 30 weeks
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 Japanease adult men 2)Subjects who signed the informed consent for participation in the study
Key exclusion criteria	1)Subjects with medical history of severe disorders 2)Subjects who judged as unsuitable for this study by the principal investigator for any reasons
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Chiyo Middle name Last name Yoshizane
Organization	Hayashibara CO., LTD.
Division name	R&D Division, Development Unit
Zip code	702-8006
Address	675-1, Fujisaki, Naka-ku, Okayama
TEL	086-276-3141
Email	chiyo.yoshizane@hb.nagase.co.jp

Public contact
Name of contact person	1st name Chiyo Middle name Last name Yoshizane
Organization	Hayashibara CO., LTD.
Division name	R&D Division, Development Unit
Zip code	702-8006
Address	675-1, Fujisaki, Naka-ku, Okayama
TEL	086-276-3141
Homepage URL
Email	chiyo.yoshizane@hb.nagase.co.jp

Sponsor
Institute	Hayashibara CO., LTD.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Ethics Committee of Hayashibara Co., Ltd.
Address	675-1,Fujisaki, Naka-ku, Okayama, Japan
Tel	086-276-3141
Email	HB96301@hb.nagase.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	株式会社林原（岡山県） / Hayashibara Co., Ltd. (Okayama)

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 31 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	65
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	2018 Year 10 Month 26 Day
Date of IRB	2018 Year 10 Month 29 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 27 Day
Last modified on	2020 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040222