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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017141
Receipt No. R000019851
Scientific Title A placebo-controlled, randomized, single-blind, parallel-group comparative study to evaluate the anti-glycation effect of a functional soymilk beverage supplemented with rice bran/rice bran oil
Date of disclosure of the study information 2015/04/15
Last modified on 2015/04/15

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Basic information
Public title A placebo-controlled, randomized, single-blind, parallel-group comparative study to evaluate the anti-glycation effect of a functional soymilk beverage supplemented with rice bran/rice bran oil
Acronym Comparative study to evaluate the anti-glycation effect of a functional soymilk beverage supplemented with rice bran/rice bran oil
Scientific Title A placebo-controlled, randomized, single-blind, parallel-group comparative study to evaluate the anti-glycation effect of a functional soymilk beverage supplemented with rice bran/rice bran oil
Scientific Title:Acronym Comparative study to evaluate the anti-glycation effect of a functional soymilk beverage supplemented with rice bran/rice bran oil
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effect on glycation stress of a consecutive 12-week ingestion of a soymilk beverage supplemented with rice bran and rice bran oil (test diet) in a placebo-controlled, randomized, single-blind, parallel-group comparison design.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin AGE fluorometry,CML content in stratum corneum,Skin elasticity test,Skin color difference analysis,Blood biochemistry(FPG,HbA1c,Insulin,CML,3DG,Pentosidine,sRAGE,esRAGE)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants 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
Each subject consumed a bottle (195 g) of the test diet once daily before the evening meal.
Interventions/Control_2 Control group
Each subject consumed a bottle (195 g) of the control diet once daily before the evening meal.
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
35 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria Healthy Japanese women between 35 and 60 years of age who 1) have been found to have high blood glucose or HbA1c levels, 2) have diabetic parents or close relatives, and/or 3) have a waist circumference of 90 cm or more are preferably recruited.
Key exclusion criteria 1) were smokers, 2) had an average sleep time of less than 5 hours/night, 3) were regularly consuming an anti-glycation diet and/or using an anti-glycation cosmetic, 4) were regularly consuming an anti-hyperglycemic diet, 5) were regularly consuming a soymilk beverage, rice bran or rice bran oil, or health food containing any of these as the main ingredient, 6) had food allergy or were allergic to specific food materials (especially soybean allergy),etc
Target sample size 25

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 Umenoi Hamada
Organization A-kit Corporation
Division name Life and Medical Sciences Inspection center
Zip code
Address Zizoudani-1chi D-egg209, Kodo, Kyotanabe-shi, Kyoto
TEL 0774-68-2050
Homepage URL
Email u-hamada@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 Sunstar Inc.
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 エイキット株式会社スキンラボ(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 15 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 07 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 10 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
2015 Year 04 Month 15 Day
Last modified on
2015 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019851

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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