UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042049 |
|---|---|
| Receipt number | R000047887 |
| Scientific Title | Effect of the test food containing plant extract on postprandial blood glucose |
| Date of disclosure of the study information | 2020/10/09 |
| Last modified on | 2021/03/17 14:29:21 |
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Basic information
Public title
Effect of the test food containing plant extract on postprandial blood glucose
Acronym
Effect of the test food containing plant extract on postprandial blood glucose
Scientific Title
Effect of the test food containing plant extract on postprandial blood glucose
Scientific Title:Acronym
Effect of the test food containing plant extract on postprandial blood glucose
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the test food on postprandial blood glucose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC of blood glucose levels
Key secondary outcomes
Postprandial blood glucose levels at 30, 60, 90 and 120 minutes after meal, AUC of blood insulin levels, Postprandial blood insulin levels at 30, 60, 90 and 120 minutes after meal
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of the placebo food -> Washout period -> Single intake of the test food 2 -> Washout period -> Single intake of the test food 1
Interventions/Control_2
Single intake of the test food 1 -> Washout period -> Single intake of the placebo food -> Washout period -> Single intake of the test food 2
Interventions/Control_3
Single intake of the test food 2 -> Washout period -> Single intake of the test food 1 -> Washout period -> Single intake of the placebo food
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 aged 20 to 64 years
2)Healthy subjects whose screening test results are not greatly out of nomal range
3)Subjects whose fasting blood glucose levels are less than 126 mg/dL, postprandial blood glucose levels are 140 mg/dL or more at 30 or 60 minutes after meal and 199 mg/dL or less at 120 minutes after meal
4)Subjects who agree to participate and can write signature and date in the written informed consent
Key exclusion criteria
1)Subjects who have a history of serious disease or digestive surgery (except for appendectomy)
2)Subjects who are considered as diabetes or have a history of that
3)Subjects who have serious complications or chronic disease
4)Subjects who habitually take medicine or supplements which may affect blood glucose level
5)Subjects who have allergy to the test food or rice
6)Subjects who are pregnant, lactating, or planning to get pregnant
7)Heavy drinker (more than 60g of alcohol per day) or heavy smoker (more than 20 cigarettes per day)
8)Subjects who are planning to participate in other clinical study during the study period
9)Subjects who have restrictions on the test food or meal for religious or other reasons
10)Subjects who are considered as an inappropriate candidate for other reasons by the doctor in charge
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Ishikawa |
Organization
Medical Corporation Shoureikan Sapporo Yushokan Hospital
Division name
Internal Medicine
Zip code
002-8042
Address
2-8-25, 2-jo, Higashibarato, Kita-ku, Sapporo, Hokkaido
TEL
011-772-9211
Ishikawa_seiryo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corporation Co., Ltd
Division name
PI-Food Service Division
Zip code
060-0061
Address
8-4-1, Minami 1-jo, Chuo-ku, Sapporo, Hokkaido
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
Medical Corporation Shoureikan Sapporo Yushokan Hospital
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical 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
Ethical Committee of Medical Corporation Hokubukai Utsukushigaoka Hospital
Address
61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido
Tel
011-82-0111
matsuda@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
Other administrative information
Date of disclosure of the study information
| 2020 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 08 | Day |
Last modified on
| 2021 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047887
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
