UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study for the Effect of The drinking vinegar which blended a mangosteen extract on Anti-glycative actions and Skin Quality
Title of the study (Brief title)	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	Yoshikazu Yonei
Organization	Doshisha University
Division name	Graduate School of Life and Medical Sciences
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	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
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)	Japanese Council for Science, Technology and Innovation (CSTI), Cross-ministerial Strategic Innovation Promotion Program

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.toukastress.jp/webj/article/2017/GS17-20.pdf
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025646