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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025893
Receipt No. R000029728
Scientific Title 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
Date of disclosure of the study information 2017/01/31
Last modified on 2017/03/12

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Basic information
Public title 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
Acronym 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
Scientific Title 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
Scientific Title:Acronym 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
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 measurement with laser doppler (First observation, Second observation)
[2]Skin surface temperature measurement with thermography (Screening, First observation, Second observation)
Key secondary outcomes *Secondary outcomes
[1]Axillary temperature (Screening, First observation, Second observation)
[2]Doctor's questions (Screening, First observation, Second observation)
[3]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

*Other indexes
[1]Height, weight, body fat percentage, BMI (Screening)
[2]Blood pressure (Screening)
[3]Subjective questionnaire on cold (Screening)
[4]Simplified Menopausal Index (Screening)

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 package in a 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 package in a 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 package in a 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 package in a 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
65 years-old >
Gender Female
Key inclusion criteria [1]Japanese females aged 20-64 years.
[2]Individuals who are healthy.
[3]Individuals who are sensitive to cold.
[4]Individuals whose written informed consent has been obtained.
[5]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 supplements 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 are 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 are a smoker.
[15]Individuals who participated in other clinical studies in the past 3 months.
[16]Individuals whose Simplified Menopausal Index score is over 51.
[17]Individuals who have a history of ovarian resection or hysterectomy.
[18]Individuals who are or are possibly, or are lactating.
[19]Individuals judged inappropriate for the study by the principal.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Nakata
Organization Medical Corporation Bokushinkai CLINTEXE Clinic
Division name Director
Zip code
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
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings Co., Ltd
Division name Administrative Department of Clinical Trials
Zip code
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL 03-6801-8480
Homepage URL
Email r.shimizu@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)

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
2017 Year 01 Month 31 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 01 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 09 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 01 Month 29 Day
Last modified on
2017 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029728

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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