UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of test food (HBF 2017-03) on human body temperature.: Single arm open-label study
Acronym	The Effect of test food (HBF 2017-03) on human body temperature
Scientific Title	The Effect of test food (HBF 2017-03) on human body temperature.: Single arm open-label study
Scientific Title:Acronym	The Effect of test food (HBF 2017-03) on human body temperature
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the test food (HBF2017-03) on body temperature in healthy adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Basal body temperature is measured daily for 16 weeks. A 4-week non-treatment baseline period. A 8-week test food intake period. A 4-week washout period.
Key secondary outcomes	1.Questionnaire survey on the physical condition every 4 weeks

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test food (HBF2017-03) once a day for 8 weeks
Interventions/Control_2
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 and Female
Key inclusion criteria	1)Healthy Japanease adults 2)Employees at the Hayashibara CO.,LTD. 3)Subjects who signed the informed consent for participation in the study
Key exclusion criteria	1)Subjects with medical fistory of sever disorders 2)Pregnant or have possibility to become pregnant during the study or lactating women 3)Subjects who judged as unsuitable for this study by the principal investigator for any reasons
Target sample size	50

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	7028006
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	7028006
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
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	2018 Year 02 Month 01 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	2017 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 23 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035345