UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034078 |
|---|---|
| Receipt number | R000038849 |
| Scientific Title | Evaluation of meal response by blood glucose monitor for personalized nutrition -pilot study- |
| Date of disclosure of the study information | 2018/09/19 |
| Last modified on | 2019/09/03 08:22:36 |
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Basic information
Public title
Evaluation of meal response by blood glucose monitor for personalized nutrition -pilot study-
Acronym
Pilot study on the evaluation of meal response by blood glucose monitor
Scientific Title
Evaluation of meal response by blood glucose monitor for personalized nutrition -pilot study-
Scientific Title:Acronym
Pilot study on the evaluation of meal response by blood glucose monitor
Region
| Japan |
Condition
Condition
Healthy male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To compare the difference in the postprandial blood glucose level in healthy adults, who ingest a low glycemic index (GI) or a high GI test meal as breakfast for 7 days.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose, serum insulin
Key secondary outcomes
Anthropometry, Clinical laboratory test, Biological markers
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of a low GI test meal for breakfast for 7 days
Interventions/Control_2
Ingestion of a high GI test meal for breakfast for 7 days
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Japanese men aged between 40 and 70 years old
Key exclusion criteria
1.Persons using implantable medical devices such as pacemakers
2.Persons undergoing dialysis
3.Person under medication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshinao |
| Middle name | |
| Last name | Goda |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
TEL
054-264-5533
gouda@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Toshinao |
| Middle name | |
| Last name | Goda |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
TEL
054-264-5533
Homepage URL
gouda@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka, School of Food and Nutritional Sciences
Institute
Department
Personal name
Funding Source
Organization
The KAITEKI Institute, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Integrative Medical Science (IMS), RIKEN
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of the University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
Tel
054-264-5102
tyous10@u-shizuoka-ken.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
SBS静岡健康増進センター（静岡県）／SBS Shizuoka Health Promotion Center （Shizuoka）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 19 | 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
20
Results
The blood glucose levels were significantly higher who intake high-GI diet at 30 minutes, 60 minutes and 120 minutes after starting breakfast ingestion than in who intake low-GI diet.
Results date posted
| 2019 | Year | 09 | Month | 03 | Day |
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 | 08 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 10 | Day |
Last modified on
| 2019 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038849
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| Registered date | File name |
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