UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025893 |
|---|---|
| Receipt number | 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 14:13:03 |
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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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029728
