UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the Effects of Long Pepper Extract on Blood Flow and Skin Surface Temperature Following the Exposure to Cold Water Stress: Placebo controlled, Randomized, Double-blind, Cross-over Study
Title of the study (Brief title)	The Effects of Long Pepper Extract on Blood Flow and Skin Surface Temperature
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines the effects of long pepper extract on blood flow and skin surface temperature following the exposure to cold water stress.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Blood flow (Preliminary observation, First bbservation, Second observation) [2]Skin surface temperature (Preliminary observation, First bbservation, Second observation)
Key secondary outcomes	[1]Subjective questionnaire (Preliminary observation, First bbservation, Second observation) [2]Physician's interview (Preliminary observation, First bbservation, Second observation)

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	[1]Oral intake of the test product (containing long pepper extract; 1 capsule / day, 1 time) [2]The exposure to cold water stress [3]Observation [4]Washout (1 week) [5]Oral intake of the placebo product (not containing long pepper extract; 1 capsule / day, 1 time) [6]The exposure to cold water stress [7]Observation
Interventions/Control_2	[1]Oral intake of the placebo product (not containing long pepper extract; 1 capsule / day, 1 time) [2]The exposure to cold water stress [3]Observation [4]Washout (1 week) [5]Oral intake of the test product (containing long pepper extract; 1 capsule / day, 1 time) [6]The exposure to cold water stress [7]Observation
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]Japanese males and females aged 20-59 years [2]Individuals who are healthy [3]Individuals whose written informed consent has been obtained [4]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis) [3]Individuals who use a drug to treat a disease [4]Individuals who were an asthmatic patient in the past 3 months or is an asthmatic patient [5]Individuals with serious anemia [6]Individuals who are sensitive to a test product or other foods, and medical products [7]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 months or will ingest those foods during the test period [8]Individuals with serious diseases (ex. diabetes, hepatopathy disease, kidney damage, heat failure, endocrine disease), or who is a patient of or have a history of thyroid disease, adrenal disease, metabolic disease) [9]Individuals who conducted hormone replacement therapy in the past 3 months or have a history of conducting hormone replacement therapy [10]Individuals who have an inflammation or a scar on a measuring area [11]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [13]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [14]Individuals who is a smoker [15]Individuals who participated in other clinical studies in the past 3 months [16]Individuals whose AMS scale is over 37 (male) [17]Individuals whose SMI score is over 51 (female) [18]Individuals who have a history of ovarian resection or hysterectomy (female) [19]Individuals whose prospected date of the ovulation is 2 days before or after the observation day (female) [20]Individuals who are or are posslibly, or are lactating (female) [21]Individuals judged inappropriate for the study by the principal
Target sample size	30

Research contact person
Name of lead principal investigator	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Director
Address	4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL	03-5405-1059
Email	info@tes-h.co.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
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)

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	2016 Year 03 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 26 Day
Anticipated trial start date	2016 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 30 Day
Last modified on	2016 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024854