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
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
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
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
