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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031576
Receipt No. R000036056
Scientific Title The effects of test food(HBF2017-04) on skin surface temperature in healthy Japanese adults: a randomized, placebo-controlled, double-blind cross-over trial
Date of disclosure of the study information 2018/03/12
Last modified on 2018/09/04

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Basic information
Public title The effects of test food(HBF2017-04) 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(HBF2017-04) 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(HBF2017-04) 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

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(HBF2017-04)
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
60 years-old >
Gender Male and Female
Key inclusion criteria (1) 20<=Age<60 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 who consume exscessive alcohol
(4) Individuals who consume exscessive smoking
(5) Individuals who has metal allergy or adhesive allergy
(6) Individuals who cannot follow orders from chief investigator or sub investigators
(7) 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
Middle name
Last name Saori Ogihara
Organization Hayashibara Co., LTD.
Division name Food materials development section, food materials division, R&D center
Zip code
Address 675-1 Fujisaki, Naka-ku, Okayama, Okayama
TEL 086-276-3141
Email ogihara.saori@hb.nagase.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saori Ogihara
Organization Hayashibara Co., LTD.
Division name Food materials development section, food materials division, R&D center
Zip code
Address 675-1 Fujisaki, Naka-ku, Okayama, Okayama
TEL 086-276-3141
Homepage URL
Email ogihara.saori@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
Address
Tel
Email

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
2018 Year 03 Month 12 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
2018 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 12 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 03 Month 05 Day
Last modified on
2018 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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