UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030954 |
|---|---|
| Receipt number | R000035345 |
| Scientific Title | The Effect of test food (HBF 2017-03) on human body temperature.: Single arm open-label study |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2020/01/31 16:31:21 |
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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
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
chiyo.yoshizane@hb.nagase.co.jp
Sponsor or person
Institute
Hayashibara CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035345
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
