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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022818
Receipt No. 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

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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
Email 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
Email info@tes-h.co.jp

Sponsor
Institute Anti-Aging Bank Co.,Ltd.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026287

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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