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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name