UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028238
Receipt number R000032320
Scientific Title A study on effect of salt-marinated rice malt (shio koji) on fasting blood glucose level : A randomized, double blinded, placebo controlled study
Date of disclosure of the study information 2018/11/03
Last modified on 2019/01/14 16:05:53

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Basic information

Public title

A study on effect of salt-marinated rice malt (shio koji) on fasting blood glucose level : A randomized, double blinded, placebo controlled study

Acronym

A study effect of salt-marinated rice malt (shio koji)on fasting blood glucose level

Scientific Title

A study on effect of salt-marinated rice malt (shio koji) on fasting blood glucose level : A randomized, double blinded, placebo controlled study

Scientific Title:Acronym

A study effect of salt-marinated rice malt (shio koji)on fasting blood glucose level

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effect of salt-marinated rice malt (shio koji) on fasting blood glucose level

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fasting blood glucose level

Key secondary outcomes

HOMA-R ,HbA1c


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

Prevention

Type of intervention

Food

Interventions/Control_1

intake of salt-marinated rice malt (shio koji) for 12 consecutive weeks

Interventions/Control_2

intake of a placebo for 12 consecutive 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

20 years-old <=

Age-upper limit

69 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Males and females from 20 to 69 years of age
(2)Fasting blood glucose level are ranged from 100 mg/dL to 125 mg/dL

Key exclusion criteria

(1)Subjects who routinely takes foods or medicines affecting the test result
(2)Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required
(3)Subjects who has under treatment or a history of serious disease (e.g., diabetes, or liver disease, kidney disease, or heart disease)
(4)Heavy smoker, Heavy drinker
(5)Subjects who is employed on a pre-dawn shift or on night duty more than 2 times
(6)Subjects having possibilities for emerging allergy related to the study.
(7)BMI is less than 18.5 or more than
30.0
(8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(9)Subjects who have donated over 400 mL of blood and/or blood components within the last three months prior to the current study
(10)Subjects who have participated in other clinical study within the last one month prior to the current study
(11)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(13)Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koike Syogo

Organization

MARUKOME Co.,Ltd.

Division name

Marketing Division Development Department

Zip code


Address

883 Amori Nagano-shi Nagano 380-0943 Japan

TEL

026-226-0165

Email

s_koike@marukome.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chiharu Goto

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code


Address

1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

c.goto@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

MARUKOME 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

2018 Year 11 Month 03 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

2017 Year 05 Month 26 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 15 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

2017 Year 07 Month 14 Day

Last modified on

2019 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032320


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name