UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042100 |
|---|---|
| Receipt number | R000048025 |
| Scientific Title | A study to evaluate a decreasing effect of a functional food on postprandial glucose levels. |
| Date of disclosure of the study information | 2020/10/14 |
| Last modified on | 2021/10/20 16:33:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to evaluate a decreasing effect of a functional food on postprandial glucose levels.
Acronym
A study to evaluate a decreasing effect of a functional food on postprandial glucose levels.
Scientific Title
A study to evaluate a decreasing effect of a functional food on postprandial glucose levels.
Scientific Title:Acronym
A study to evaluate a decreasing effect of a functional food on postprandial glucose levels.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a functional food on postprandial hyperglycemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum concentration and area under the curve of blood glucose levels.
Key secondary outcomes
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
a single ingestion of the test food and white rice
-> more than 3 days of washout period
-> a single ingestion of the control food and white rice
Interventions/Control_2
a single ingestion of the control food and white rice
-> more than 3 days of washout period
-> a single ingestion of the test food and white rice
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) Healthy male and female whose age are 20 <= years old <65.
(2) Subjects who are able to submit the written informed consents.
Key exclusion criteria
(1) Systolic pressure <90 mmHg
(2) Subjects who are pregnant or lactating.
(3) Subjects who donated over 200ml blood components or whole blood within 4 weeks
(4) Male Subjects who donated over 400ml whole blood within 12 weeks
(5) Female who donated over 400ml whole blood within 16 weeks
(6) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
(7) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
(8) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks.
(9)
a) Subjects with disease on heart, liver, kidney or the other organs complication.
b) Subjects with a previous history of disease on circulatory organs
c) Subjects who are contracting diabetes.
d) Subjects with test food allergy
(10) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nonaka |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, 619-0284 Japan
TEL
050-3182-0587
Yuji_Nonaka@suntory.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kanamori |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, 619-0284 Japan
TEL
050-3182-0543
Homepage URL
Takeshi_Kanamori@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Committee
Address
61-1 Shinei, Kiyota-ku, Sapporo, 004-0839 Japan
Tel
011-881-0111
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 | 14 | 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 | 17 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 26 | 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 | 13 | Day |
Last modified on
| 2021 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048025
