UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051003 |
|---|---|
| Receipt number | R000058131 |
| Scientific Title | Correlation analysis of eating behaviors and blood glucose level using antioxidant foods |
| Date of disclosure of the study information | 2023/05/08 |
| Last modified on | 2023/05/08 12:42:32 |
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Basic information
Public title
Correlation analysis of eating behaviors and blood glucose level using antioxidant foods
Acronym
Correlation analysis of eating behaviors and blood glucose level using antioxidant foods
Scientific Title
Correlation analysis of eating behaviors and blood glucose level using antioxidant foods
Scientific Title:Acronym
Correlation analysis of eating behaviors and blood glucose level using antioxidant foods
Region
| Japan |
Condition
Condition
glucose metabolism
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postprandial hyperglycemia could be caused by mental-stress-induced overeating. Hyperglycemia is a primary risk factor of not only diabetes mellitus and its complications but also critical diseases typically including heart failure and brain infarction.
Snacking is a promising way for avoidance of postprandial hyperglycemia. However, it has a self-contradicting drawback that snacking itself has a risk of increasing glucose level. To overcome such issue, a variety of natural antioxidant foods having an effect of suppressing postprandial increase of glucose level have been developed.
The current study aims to clarify how glucose level changes by eating such antioxidant foods for snacking in a daily life, taking into account various confounding factors including mealtime, glucose tolerance, body composition, age, sex, etc. To this end, subjects are aske to take snacking with target snack foods in accordance with instruction while maintain usual meal behaviors. The study period is two weeks. Subjects are required to wear a continuous glucose monitoring (CGM) sensor which records glucose level at every fifteen minutes.
The outcome of the study will evidence optimal snacking for health promotion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome
Measurements
Daily glucose fluctuations by using a continuous glucose monitoring system (Freestyle Libre Pro, Abbot Diabetes Care Inc., USA, Japanese pharmaceutical approval: 22800BZX00227000).
Glucose profiles are consistently measured during the 14-day test period.
Measurement outcomes
Basic glucose response:
(a) Effective glucose peak value (Gp) from glucose baseline
(b) net MAGE (mean amplitude of glucose excursion)
Definition of Net MAGE
MAGE was defined as the average of upward (MAGE(+)) and downward (MAGE(-)) excursions exceeding the standard deviation of glycemic excursion data over a day measured by CGM as follows:
MAGE=(MAGE(+) + MAGE(-))/2
Glycemic excursion fluctuations can be evaluated by the upper and lower envelopes of excursion profiles. Net glycemic fluctuation amplitudes (net MAGE) defined for each glycemic peak as abs[G(i)-GN(i)], where G(i) and GN(i) are glucose peak and baseline value of the ith peak of the daily glucose excursion profile.
Key secondary outcomes
Glucose levels measured at every 15 minutes during study period of 14 days
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
14 days
64 pieces
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male/female daytime workers
Age: 20-75
Education: High-school graduate level
Key exclusion criteria
Subjects who take mediations acting on glucose metabolism
(Steroid, NSAIDS (non-steroid anti-inflammatory drugs), Anti-diabetes drugs)
Those who have a risk of subcutaneous bleeding by inserting a continuous glucose monitoring (CGM) sensor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshitada |
| Middle name | |
| Last name | Katagiri |
Organization
The University of Tokyo
Division name
Biosystems Engineering for Health and Longevity, Department of Bioengineering, School of Engineering
Zip code
Tokyo 133-8655 Japan
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 133-8655 Japan
TEL
+81-3-3581-1294
tkatagiri@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Katagiri |
Organization
The University of Tokyo
Division name
Biosystems Engineering for Health and Longevity, Department of Bioengineering, School of Engineering
Zip code
Tokyo 133-8655 Japan
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 133-8655 Japan
TEL
+81-3-3581-1294
Homepage URL
tkatagiri@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, The Environmental Health and Safety Office, School of Engineering, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 133-8655 Japan
Tel
+81 3 5841-1846
rinri@anzen.t.u-tokyo.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 | 05 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058131
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| Registered date | File name |
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