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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034398
Receipt No. R000039215
Scientific Title Effect of test food on the postprandial blood glucose level -A randomized, double blind, placebo controlled, cross-over study-
Date of disclosure of the study information 2018/10/09
Last modified on 2018/10/05

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Basic information
Public title Effect of test food on the postprandial blood glucose level -A randomized, double blind, placebo controlled, cross-over study-
Acronym Effect of test food on the postprandial blood glucose level
Scientific Title Effect of test food on the postprandial blood glucose level -A randomized, double blind, placebo controlled, cross-over study-
Scientific Title:Acronym Effect of test food on the postprandial blood glucose level
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of test food on the postprandial blood glucose level of subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Area under the curve (AUC) for postprandial blood glucose level
Key secondary outcomes AUC for postprandial insulin level, and insulin levels and blood glucose levels at 30, 60, 90, and 120 minutes after rice ingestion

Base
Study type Interventional

Study design
Basic design Cross-over
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 Treatment
Type of intervention
Food
Interventions/Control_1 Intake of test food, and then intake of placebo after wash out period
Interventions/Control_2 Intake of placebo, and then intake of test food after wash out period
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Males and females 20 to 64 years of age
2)Subjects whose fasting blood glucose levels are less than 126 mg/dL
3)Subjects whose HbA1c(NGSP) are less than 6.5%
4)Subjects whose postprandial blood glucose levels at 30 or 60 minutes after 200g rice ingestion are more than 140 mg/dL
5)Subjects whose postprandial blood glucose levels at 120 minutes after 200g rice ingestion are less than 200 mg/dL
6)Subjects who consent to participate in the study, and can sign the consent form
Key exclusion criteria 1)Subjects who has serious medical history or who had digestive tract resection surgery
2)Subjects who routinely use medicine, supplements, FOSHU, and/or health food which affect to result of the study
3)Subjects who have allergy to the test food or rice
4)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating
5)Heavy use of alcohol or excessive smokers
6)Subjects who is considered to be inappropriate to attend the present study by the investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Yui
Organization FANCL Corporation
Division name Research Institute
Zip code
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL 045-820-3755
Email ke-yui@fancl.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Naito
Organization Kenkoin Medical corporation foundation
Division name Kenkoin Clinic
Zip code
Address 6-7-4, Ginza, Chuo-ku, Tokyo, Japan
TEL 03-3573-1153
Homepage URL
Email reiko-naito@kenkoin.jp

Sponsor
Institute FANCL Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
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 医療法人財団健康院 健康院クリニック

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 09 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 12 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
2018 Year 10 Month 05 Day
Last modified on
2018 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039215

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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