UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049969 |
|---|---|
| Receipt number | R000056914 |
| Scientific Title | A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose: a randomized, placebo-controlled, double-blind, crossover comparison trial |
| Date of disclosure of the study information | 2023/01/05 |
| Last modified on | 2023/08/21 13:14:55 |
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Basic information
Public title
A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose
Acronym
A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose
Scientific Title
A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose: a randomized, placebo-controlled, double-blind, crossover comparison trial
Scientific Title:Acronym
A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the suppressive effect of the test food consumption on the elevation of postprandial blood glucose in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The incremental area under the curve (IAUC) of the postprandial blood glucose
Key secondary outcomes
1. The maximum blood concentration (Cmax) of the postprandial glucose
2. The blood glucose before consumption of the test food and 30, 60, 90, and 120 minutes after carbohydrate load
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Period I: Placebo food A
Period II: Test food A
Period III: Placebo food B
Period IV: Test food B
* Carbohydrate load: Rice (200 g)
After taking blood samples prior to the ingestion of test foods, take 1.5 g of the test food or placebo food with water. Then, take the carbohydrate load.
* The order of intervention is Period I, Period II, Period III, Period IV, and a single dose.
* The washout period is four days or longer.
Interventions/Control_2
Period I: Test food A
Period II: Placebo food A
Period III: Test food B
Period IV: Placebo food B
* Carbohydrate load: Rice (200 g)
After taking blood samples prior to the ingestion of test foods, take 1.5 g of the test food or placebo food with water. Then, take the carbohydrate load.
* The order of intervention is Period I, Period II, Period III, Period IV, and a single dose.
* The washout period is four days or longer.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Subjects aged 18 or more
4. Healthy subjects
5. Subjects whose fasting blood glucose levels are less than 126 mg/dL, and 2-h postprandial blood glucose levels are less than 200 mg/dL (before consumption; Scr)
6. Subjects who have received a full explanation of the study, can understand its contents, and have given their written informed consent to participate in the study
Key exclusion criteria
1. A medical history of malignant tumor, heart failure or myocardial infarction.
2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus.
3. Subjects who are currently taking medications (including herbal medicines) and dietary supplements
4. Subjects who are allergic to the test food related products.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Shimada |
Organization
Gifu University
Division name
Faculty of Applied Biological Sciences
Zip code
501-1193
Address
1-1 Yanagido, Gifu City 501-1193, JAPAN
TEL
058-293-2861
mshimada@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Shimada |
Organization
Gifu University
Division name
Faculty of Applied Biological Sciences
Zip code
058-293-2861
Address
1-1 Yanagido, Gifu City 501-1193, JAPAN
TEL
058-293-2861
Homepage URL
mshimada@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
San-ei Sucrochemical 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
Gifu University Graduate School of Medicine/School of Medicine
Address
1-1 Yanagido, Gifu City 501-1194, JAPAN
Tel
058-230-6059
rinri@gifu-u.ac.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
| 2023 | Year | 01 | Month | 05 | 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
31
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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056914
