UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028238
Receipt No. R000032320
Official scientific title of the study 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 2017/12/18

* 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
Official scientific title of the study A study on effect of salt-marinated rice malt (shio koji) on fasting blood glucose level : A randomized, double blinded, placebo controlled study
Title of the study (Brief title) 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 Koike Syogo
Organization MARUKOME Co.,Ltd.
Division name Marketing Division Development Department
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 Chiharu Goto
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Address 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email c.goto@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 05 Month 26 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2017 Year 07 Month 14 Day
Last modified on
2017 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.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


Contact us.