UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022818 |
|---|---|
| Receipt number | R000026287 |
| Scientific Title | Examination of the Effects of The drinking vinegar which blended a mangosteen extract on Blood Flow and Skin Surface Temperature Following the Exposure to Cold Water Stress |
| Date of disclosure of the study information | 2017/06/20 |
| Last modified on | 2016/12/21 12:02:14 |
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Basic information
Public title
Examination of the Effects of The drinking vinegar which blended a mangosteen extract on Blood Flow and Skin Surface Temperature Following the Exposure to Cold Water Stress
Acronym
A Study for the Effects of The drinking vinegar which blended a mangosteen extract on Blood Flow
Scientific Title
Examination of the Effects of The drinking vinegar which blended a mangosteen extract on Blood Flow and Skin Surface Temperature Following the Exposure to Cold Water Stress
Scientific Title:Acronym
A Study for the Effects of The drinking vinegar which blended a mangosteen extract on Blood Flow
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 The drinking vinegar which blended a mangosteen 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 (1 day,1 time)
[2]The exposure to cold water stress
[3]Observation
[4]Washout (2 week)
[5]Oral intake of the placebo product (1 day,1 time)
[6]The exposure to cold water stress
[7]Observation
Interventions/Control_2
[1]Oral intake of the placebo product (1 day,1 time)
[2]The exposure to cold water stress
[3]Observation
[4]Washout (2 week)
[5]Oral intake of the test product (1 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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Japanese females after menopause aged 45-65 years
[2]Individuals who are healthy and do not treat any disease
[3]Individuals with objective feeling chillness and individual who can admit that it's a chillness objectively in a chillness questionnaire
[4]Individuals whose written informed consent has been obtained
[5]Individuals who can have an examination on a designated check day
[6]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[1]Individuals using medical products
[2]Individuals who are or are under treatment or have a history of mental disabilities,sleep disorder,hypertension,diabetes,fat metabolism or the other serious dysfunctions
[3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it.)[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease
[5]Individual who have digestive organ disease(disease of an appendix is removed)
[6]Individuals whose BMI is over 30 kg/m2
[7]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[8]Individuals with serious anemia
[9]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies
[10]Individual who is based on average alcohol per 1 day and exceeds 60g/day
[11]Individuals whose life style will change during the test period (ex. travel for a long time)
[12]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
[13]Individuals whose SMI score is over 51
[14]Individuals who have a history of ovarian resection or hysterectomy
[15]Individuals who participated in other clinical studies in the past 3 months
[16]Individuals judged inappropriate for the study by the principal
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Yonei |
Organization
Doshisha University
Division name
Graduate School of Life and Medical Sciences
Zip code
Address
1-3 Tatara Miyakodani Kyotanabe City Kyoto, 610-0394, Japan
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Tamura |
Organization
TES Holdings Co., Ltd.
Division name
Department of Clinical Trial
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
info@tes-h.co.jp
Sponsor or person
Institute
Anti-Aging Bank Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
YOMEISHU SEIZO 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
株式会社TESホールディングス肌関連試験用検査施設 東京大学内CTC（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 20 | 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
| 2016 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 21 | 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
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2016 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026287
