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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012820
Receipt No. R000014938
Scientific Title A randomized control trial of UNAHATAKE herb extract intake on anti- glycation effect and improvement in skin.
Date of disclosure of the study information 2014/01/14
Last modified on 2016/05/02

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Basic information
Public title A randomized control trial of UNAHATAKE herb extract intake on anti- glycation effect and improvement in skin.
Acronym Anti-glycation effect of "herb extract" on human skin.
Scientific Title A randomized control trial of UNAHATAKE herb extract intake on anti- glycation effect and improvement in skin.
Scientific Title:Acronym Anti-glycation effect of "herb extract" on human skin.
Region
Japan

Condition
Condition Post-menopausal middle-aged female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the anti-glyaction effect ond skin inmrovement by 12-week oral treatment of UNAHANA herb extract.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin elasticity, skin CML, skin AGEs accumulation, skin color, skin image analysis by VISIA, fasting plasma glucose, insulin, CML, 3-deoxyglucosone, pentosidine, questionnaire
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Test group
Oral intake of capsules with 300mg UNAHATAKE herb extract after breakfast for 12 weeks
Interventions/Control_2 Control group
Oral intake of capsules without UNAHATAKE herb extract after breakfast for 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 Post-menopause healthy Japanese women ages 45 or more and less than 65 years old
Key exclusion criteria 1) Persons less than 2 years after menopause
2) Smoking persons
3) Users of anti-glycation materials
4) Users of medicines or supplements affecting blood glucose
5) Persons with severe dysfunction of liver, kidney or heart
6) Persons with food allergy or allergic dermatitis
7) Persons who received gastrointestinal surgery
8) Persons with high BMI more than 30
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Yonei
Organization Graduate School of Life and Medical Sciences, Doshisha University
Division name Anti-Aging Medical Research Center
Zip code
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL 0774-65-6394
Email yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichi Naito
Organization A-kit Corporation
Division name Life and Medical Sciences Inspection center
Zip code
Address 4-3-2 sawaragi-nishi,Ibaraki City,Osaka
TEL 072-646-7761
Homepage URL
Email naito@a-kit.co.jp

Sponsor
Institute Anti-Aging Medical Research Center, Graduate School of Life and Medical Sciences, Doshisha University
Institute
Department

Funding Source
Organization CONCORD CO.,LTD
HIKAWA 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

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 14 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
2013 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 14 Day
Last follow-up date
2014 Year 11 Month 30 Day
Date of closure to data entry
2014 Year 11 Month 30 Day
Date trial data considered complete
2014 Year 11 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 10 Day
Last modified on
2016 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014938

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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