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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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