UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022273 |
|---|---|
| Receipt number | R000025646 |
| Scientific Title | A Study for the Effect of The drinking vinegar which blended a mangosteen extract on Anti-glycative actions and Skin Quality |
| Date of disclosure of the study information | 2016/05/16 |
| Last modified on | 2017/10/03 16:14:56 |
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Basic information
Public title
A Study for the Effect of The drinking vinegar which blended a mangosteen extract on Anti-glycative actions and Skin Quality
Acronym
A Study for the Effect of The drinking vinegar which blended a mangosteen extract on Anti-glycative actions and Skin Quality
Scientific Title
A Study for the Effect of The drinking vinegar which blended a mangosteen extract on Anti-glycative actions and Skin Quality
Scientific Title:Acronym
A Study for the Effect of The drinking vinegar which blended a mangosteen extract on Anti-glycative actions and Skin Quality
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate efficacy of take the drinking vinegar which blended a mangosteen extract for 12 weeks on Anti-glycative actions and skin quality by Japanese adult female after menopause (aged 45-65 years).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin moisture content(4W,8W,12W)
Transepidermal water loss(4W,8W,12W)
Skin viscoelasticity(4W,8W,12W)
Color-difference(4W,8W,12W)
Image analysis by VISIA(12W)
Skin AGE deposition(4W,8W,12W)
d-ROMs Test(4W,8W,12W)
BAP Test(4W,8W,12W)
MDA-LDL(4W,8W,12W)
3-Deoxyglucosone(4W,8W,12W)
CML(4W,8W,12W)
Pentosidine in blood(4W,8W,12W)
Insulin(4W,8W,12W)
Pentosidine in urine(4W,8W,12W)
Isoprostane(4W,8W,12W)
8-OHdG(4W,8W,12W)
Key secondary outcomes
Blood pressure, pulsation
Weight, body fat percentage, BMI
Hematological examination
Blood biochemistry
Urinalysis
Doctor's questions
Subject's diary
Anti-Aging QOL Common Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Oral ingestion of the test product (12 weeks)
Interventions/Control_2
Oral ingestion of the control product (12 weeks)
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 40-65 years
[2]Individuals who are healthy and do not treat any disease(including a skin disease)
[3]Individuals who are aware of skin elasticity or dullness
[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 with absorption and an application custom of the medicine which had disease treatment for its object in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it.)
[3]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease
[4]Individual who have digestive organ disease(disease of an appendix is removed)
[5]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg
[6]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[7]Individuals with serious anemia
[8]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies
[9]Individual who is pregnant or lactate
[10]Individuals who are alcohol dependent or have other mental disabilities
[11]Individuals with smoking habit
[12]Individuals whose bowel habit is irregular
[13]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time)
[14]Individuals of sensitive skin
[15]Individuals with skin disease, such as atopic dermatitis
[16]Individuals who have an inflammation or a scar on a measuring area
[17]Individuals with probable seasonal allergy, such as pollinosis, during the test period and with a possibility that medical supplies are used (The eye drops and the nose drop are possible.)
[18]Individuals who becomes negligent of skin care extremely (persons busy with work, domesticities and child care)
[19]Individuals who will get sunburned during the test period
etc.
Target sample size
24
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)
Japanese Council for Science, Technology and Innovation (CSTI), Cross-ministerial Strategic Innovation Promotion Program
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
医療法人社団和啓会 メディクス本郷クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.toukastress.jp/webj/article/2017/GS17-20.pdf
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 | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 16 | 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 | 05 | Month | 11 | Day |
Last modified on
| 2017 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025646
