UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054029 |
|---|---|
| Receipt number | R000061680 |
| Scientific Title | Effects of pre-meal intake timing and amount of salt-grilled salmon on postprandial blood glucose in healthy subjects. |
| Date of disclosure of the study information | 2024/04/02 |
| Last modified on | 2024/04/01 17:06:29 |
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Basic information
Public title
Effects of pre-meal intake timing and amount of salt-grilled salmon on postprandial blood glucose in healthy subjects.
Acronym
Effects of pre-meal intake timing and amount of salt-grilled salmon on postprandial blood glucose in healthy subjects.
Scientific Title
Effects of pre-meal intake timing and amount of salt-grilled salmon on postprandial blood glucose in healthy subjects.
Scientific Title:Acronym
Effects of pre-meal intake timing and amount of salt-grilled salmon on postprandial blood glucose in healthy subjects.
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been shown that ingesting protein and fat before meals can suppress the rise in postprandial blood glucose in healthy subjects and diabetic patients. In this study, we evaluated the effects of the timing and amount of pre-meal intake of salt-grilled salmon on postprandial blood glucose in healthy subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postprandial blood glucose
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingested 120 g of salt-grilled salmon 30 minutes after ingesting 150 g of cooked rice
Interventions/Control_2
Ingestion of 120 g of salt-grilled salmon and 150 g of cooked rice 30 minutes later
Interventions/Control_3
Ingestion of 120 g of salt-grilled salmon and 150 g of cooked rice 5 minutes later
Interventions/Control_4
Ingestion of 40 g of salt-grilled salmon and 150 g of cooked rice 30 minutes later
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
Healthy subjects over 18 years old who are able to self-measure their blood glucose
Key exclusion criteria
People with allergies to ingested foods
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | kenji |
| Middle name | |
| Last name | yoshino |
Organization
tokai gakuen university
Division name
department of health and nutiriton
Zip code
4688514
Address
2-901 Nakahira,Tenpaku-ku, Nagoya Aichi
TEL
052-801-6620
isejimaaya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | kenji |
| Middle name | |
| Last name | yoshino |
Organization
tokai gakuen university
Division name
department of health and nutiriton
Zip code
4688514
Address
2-901 Nakahira,Tenpaku-ku, Nagoya Aichi
TEL
052-801-6620
Homepage URL
isejimaaya@yahoo.co.jp
Sponsor or person
Institute
tokai gakuen university, department of health and nutiriton, yoshino kenji
Institute
Department
Personal name
Funding Source
Organization
nothing
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
tokai gakuen university
Address
2-901 Nakahira,Tenpaku-ku, Nagoya Aichi
Tel
052-801-6620
isejimaaya@yahoo.co.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
| 2024 | Year | 04 | Month | 02 | 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
11
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 | 02 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061680
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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