UMIN-CTR Clinical Trial

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	Completed
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	2022 Year 10 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052128