UMIN-CTR Clinical Trial

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	Completed
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	2019 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032320