UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031825 |
|---|---|
| Receipt number | R000036348 |
| Scientific Title | A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion |
| Date of disclosure of the study information | 2018/03/22 |
| Last modified on | 2018/07/19 14:19:03 |
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Basic information
Public title
A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Acronym
A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Scientific Title
A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Scientific Title:Acronym
A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the
effect of single ingestion of inulin-containing food on postprandial blood glucose level by performing the comparison suing cross-over study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial blood glucose level(AUC,C-Max)
Key secondary outcomes
Awareness questionnaire
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of study food substance (Once)
Ingestion of control food substance (Once)
Interventions/Control_2
Ingestion of control food substance (Once)
Ingestion of study food substance (Once)
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) Subjects who is healthy adults of both sexes above 20 years old- under 65 years old
2) Subjects with fasting blood glucose level under 125mg/dL, and under 199mg/dL after food load at the point of screening
3) Subjects who give consent in writing with full understanding
Key exclusion criteria
1)Subjects who has difficulties to participate this study due to hepatic, kidney, cardiac disorders, lung disorder, digestive system disorder, blood disorder, endocrine disorder, metabolic defect and other serious disorders.
2)Subjects who suffer from diseases/ disorders with continuous medical treatment or with medical history of severe diseases/ disorders needed medical treatment
3)Subjects who suffer from diseases/ disorders that affects the study and are receiving medical treatment from medical institution or have surgical history of digestive system (except appendectomy)
4)Subjects with history of sensitivity to the ingredients of test food
5)Pregnant, lactating women or willing to be pregnancy during the study
6)Subjects who had participated in other clinical trials including drug and food within 1 month.
7)Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouji Takata |
Organization
NIHONDO Co.,Ltd.
Division name
Brand Promotion Department
Zip code
Address
4-7-35 kitashinagaw,shinagawa-ku ,Tokyo,140-0001,Japan
TEL
03-3446-2011
k.takata@nihondo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Imai |
Organization
CROee.INC
Division name
Evidence Division
Zip code
Address
2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL
03-5953-2108
Homepage URL
imai@croee.com
Sponsor or person
Institute
CROee.INC Evidence Division
Institute
Department
Personal name
Funding Source
Organization
NIHONDO 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
東京センタークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 22 | 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 | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 02 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 08 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 21 | Day |
Last modified on
| 2018 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036348
