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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045664
Receipt No. R000052128
Scientific Title Effect of intake of Long pepper extract on skin surface temperature after cold water immersion
Date of disclosure of the study information 2021/10/06
Last modified on 2021/10/05

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Basic information
Public title Effect of intake of Long pepper extract on skin surface temperature after cold water immersion
Acronym Effect of intake of Long pepper extract on skin surface temperature after cold water immersion
Scientific Title Effect of intake of Long pepper extract on skin surface temperature after cold water immersion
Scientific Title:Acronym Effect of intake of Long pepper extract on skin surface temperature after cold water immersion
Region
Japan

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

Objectives
Narrative objectives1 To examine the effects of intake of Long pepper extract on skin surface temperature after cold water immersion in young female subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of skin surface temperature
Key secondary outcomes 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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food with Long pepper extract (single intake) - washout period more than 3 days - Intake of placebo food (single intake)
Interventions/Control_2 Intake of placebo food (single intake) - washout period more than 3 days - Intake of test food with Long pepper extract (single intake)
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

Not applicable
Gender Female
Key inclusion criteria 1. Healthy female adults aged over 20 years old.
2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria Subjects who may have an allergic reaction to the test food, and subjects who may have a severe allergic reaction to other foods or medicines.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Motoko
Middle name
Last name Takaoka
Organization Kobe College
Division name School of Human Sciences, Department of Biosphere Sciences
Zip code 662-8506
Address 4-1 Okadayama, Nhishinomiya, Hyogo, Japan
TEL 0798-51-8668
Email takaoka@mail.kobe-c.ac.jp

Public contact
Name of contact person
1st name Motoko
Middle name
Last name Takaoka
Organization Kobe College
Division name School of Human Sciences, Department of Biosphere Sciences
Zip code 662-8506
Address 4-1 Okadayama, Nhishinomiya, Hyogo, Japan
TEL 0798-51-8668
Homepage URL
Email takaoka@mail.kobe-c.ac.jp

Sponsor
Institute Kobe College
Institute
Department

Funding Source
Organization Maruzen Pharmaceuticals Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kobe College
Address 4-1 Okadayama, Nhishinomiya, Hyogo, Japan
Tel 0798-51-8423
Email takaoka@mail.kobe-c.ac.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 神戸女学院大学

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 06 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 Preinitiation
Date of protocol fixation
2021 Year 08 Month 20 Day
Date of IRB
2021 Year 09 Month 02 Day
Anticipated trial start date
2021 Year 10 Month 07 Day
Last follow-up date
2021 Year 12 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
2021 Year 10 Month 05 Day
Last modified on
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052128

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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