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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035623
Receipt No. R000040545
Scientific Title Suppressive 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 2019/02/01
Last modified on 2019/08/06

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

Condition
Condition Adult men and women
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 for postprandial blood glucose level.
Key secondary outcomes Area under the curve for postprandial blood glucose levels, and insulin levels and postprandial 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 NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of test food (single ingestion) - washout period - intake of placebo (single ingestion)
Interventions/Control_2 Intake of placebo (single ingestion) - washout period - intake of test food (single ingestion)
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 from 20 to 64 years of age.
2)Subjects whose fasting blood glucose levels is 125 mg/dL or less.
3)Subjects whose postprandial blood glucose levels at 30 or 60 minutes after 200g rice ingestion is 140 mg/dL or less.
4)Subjects whose postprandial blood glucose levels at 120 minutes after 200g rice ingestion is 199 mg/dL or less.
Key exclusion criteria 1)Subjects who have serious medical history or who had digestive tract resectional surgery (except for appendectomy).
2)Subjects whose HbA1c(NGSP) is 6.5% or more.
3)Subjects who routinely use medicine, supplements, FOSHU, and/or health food which may affect the result of the study.
4)Subjects who have allergy to the test food or rice.
5)Subjects who are planning to become pregnant during informed consent for the current study or are pregnant or lactating.
6)Heavy use of alcohol or heavy smokers.
7)Subjects who are judged as inappropriate to participate in the study by the investigator for other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazuhiko
Middle name
Last name Takano
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name Clinical Pharmacology Center
Zip code 004-0839
Address 61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan
TEL 001-882-0111
Email takano@ughp-cpc.jp

Public contact
Name of contact person
1st name Isao
Middle name
Last name Takehara
Organization Clinical Support Corporation Limited
Division name Food Service Division
Zip code 060-0061
Address 4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan
TEL 011-223-3130
Homepage URL
Email takehara@csc-smo.co.jp

Sponsor
Institute FANCL Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical corporation Hokubukai beauty hill hospital ethics review committee
Address No. 61, Maeda, Kiyota-ku, Sapporo, Hokkaido
Tel 011-882-0111
Email wakimoto@ughp-cpc.jp

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 医療法人北武会美しが丘病院(北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 01 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
2018 Year 12 Month 13 Day
Date of IRB
2019 Year 01 Month 10 Day
Anticipated trial start date
2019 Year 02 Month 13 Day
Last follow-up date
2019 Year 02 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 22 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040545

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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