UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017141 |
|---|---|
| Receipt number | 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 11:57:05 |
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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
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
u-hamada@a-kit.co.jp
Sponsor or person
Institute
Anti-Aging Medical Research Center, Graduate School of Life and Medical Sciences, Doshisha University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019851
