UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051014 |
|---|---|
| Receipt number | R000058156 |
| Scientific Title | Research to evaluate the post-meal blood glucose response. (SWE-2023-03-HBLACT) |
| Date of disclosure of the study information | 2023/05/13 |
| Last modified on | 2023/11/07 09:58:38 |
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Basic information
Public title
Research to evaluate the post-meal blood glucose response. (SWE-2023-03-HBLACT)
Acronym
Research to evaluate the post-meal blood glucose response.
Scientific Title
Research to evaluate the post-meal blood glucose response. (SWE-2023-03-HBLACT)
Scientific Title:Acronym
Research to evaluate the post-meal blood glucose response.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the post-meal blood glucose response from various lifestyle and health indicators.
Basic objectives2
Others
Basic objectives -Others
Evaluate the post-meal blood glucose response from various lifestyle and health indicators.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-meal blood glucose response.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Diet interventions for 7 days
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women who are between 30 and 79 years of age.
(2) Those who fully understand the purpose and content of this study and have given their written consent.
Key exclusion criteria
(1) Those who use pharmaceuticals that may affect postprandial blood glucose regularly.
(2) Those who have food allergies
(3) Those with dietary restrictions such as carbohydrate restriction, vegetarianism, etc.
(4) Those who have an extremely irregular lifestyle
(5) Other subjects deemed inappropriate for the study by the principal investigator.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Obata |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0568
Hidenori_Obata@suntory.co.jp
Public contact
Name of contact person
| 1st name | Hiroka |
| Middle name | |
| Last name | Sakanaka |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-5479
Homepage URL
Hiroka_Sakanaka@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Wellness Limited
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 review committee, Kanazawabunko Hospital
Address
2-6-22 Kamariya Higashi, Kanazawa-ku, Yokohama, Kanagawa
Tel
0570-783-706
h.itou@kanabun-hp.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 | 05 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 23 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058156
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
