UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029021 |
|---|---|
| Receipt number | R000033195 |
| Scientific Title | The effects of test food(HBF2017-02) on skin surface temperature in healthy Japanese adults: a randomized, placebo-controlled, double-blind cross-over trial |
| Date of disclosure of the study information | 2017/09/07 |
| Last modified on | 2020/01/31 16:30:52 |
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Basic information
Public title
The effects of test food(HBF2017-02) on skin surface temperature in healthy Japanese adults: a randomized, placebo-controlled, double-blind cross-over trial
Acronym
The effects of test food on skin surface temperature in healthy Japanese adults
Scientific Title
The effects of test food(HBF2017-02) on skin surface temperature in healthy Japanese adults: a randomized, placebo-controlled, double-blind cross-over trial
Scientific Title:Acronym
The effects of test food on skin surface temperature in healthy Japanese adults
Region
| Japan |
Condition
Condition
healthy humans
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of test food(HBF2017-02) on skin surface temperature in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin surface temperature
Key secondary outcomes
skin blood flow, feeling questionnaire
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
Single-dose oral ingestion of the test food(HBF2017-02)
Interventions/Control_2
Single-dose oral ingestion of the placebo control food
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) 20<=Age<65 of healty men and women
Key exclusion criteria
(1) Individuals with a disease under trea tment now
(2) Individuals who has been pregnantor subject who have a plan to become pregnant or breast feed during the stu dy period
(3) Individuals with intestine or hepatic impairment
(4) Individuals who consume exscessive alcohol
(5) Individuals who consume exscessive smoking
(6) Individuals who are taking medication or functional foods which might affect the results of this study, such as medicine, quasi drug and health foods in the past 1 week or will ingest those foods during the test period
(7) Individuals who has metal allergy or adhesive allergy
(8) Individuals who cannot follow orders from chief investigator or sub investigators
(9) Individuals who are judged as inappropriate to be enrolled in this trials by chief investigator or sub investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Ogihara |
Organization
Hayashibara Co., LTD.
Division name
R&D Division, Development Unit
Zip code
7028006
Address
675-1 Fujisaki, Naka-ku, Okayama, Okayama
TEL
086-276-3141
ogihara.saori@hb.nagase.co.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Ogihara |
Organization
Hayashibara Co., LTD.
Division name
R&D Division, Development Unit
Zip code
7028006
Address
675-1 Fujisaki, Naka-ku, Okayama, Okayama
TEL
086-276-3141
Homepage URL
ogihara.saori@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
| 2017 | Year | 09 | Month | 07 | 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 | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 07 | 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
| 2017 | Year | 09 | Month | 06 | 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=R000033195
