UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047131 |
|---|---|
| Receipt number | R000053762 |
| Scientific Title | The food intake sequence in daily meals improves postprandial glycemic excursions in healthy adults |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2022/03/09 18:05:21 |
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Basic information
Public title
The food intake sequence in daily meals improves postprandial glycemic excursions in healthy adults
Acronym
The food intake sequence in daily meals improves postprandial glycemic excursions in healthy adults
Scientific Title
The food intake sequence in daily meals improves postprandial glycemic excursions in healthy adults
Scientific Title:Acronym
The food intake sequence in daily meals improves postprandial glycemic excursions in healthy adults
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate whether the meal sequence in the real-life diet affects postprandial glucose variability in healthy people.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial glucose concentrations after the test meals are measured over 4 hours using a continuous glucose monitor (CGM).
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Japanese set meal (1913-2219 kJ, P 14.8-25.6 g; F 8.9-16.0 g; C 68.3-79.1 g)
(1) non-rice 15 minutes before rice (-15 dish)
Interventions/Control_2
Japanese set meal (1913-2219 kJ, P 14.8-25.6 g; F 8.9-16.0 g; C 68.3-79.1 g)
(2) non-rice 10 minutes before rice (-10 dish)
Interventions/Control_3
Japanese set meal (1913-2219 kJ, P 14.8-25.6 g; F 8.9-16.0 g; C 68.3-79.1 g)
(3) non-rice 5 minutes before rice (-5 dish)
Interventions/Control_4
Japanese set meal (1913-2219 kJ, P 14.8-25.6 g; F 8.9-16.0 g; C 68.3-79.1 g)
(4) any order participants like (simultaneous)
Interventions/Control_5
Japanese set meal (1913-2219 kJ, P 14.8-25.6 g; F 8.9-16.0 g; C 68.3-79.1 g)
(5) non-rice 15 minutes after rice (+15 dish)
Interventions/Control_6
Beef rice bowl consisted of 220 g of steamed rice and simmered beef and onions(2625 kJ, P 19.4 g; F 20.4 g; C 87.6 g)
(1) non-rice 15 minutes before rice (-15beef)
Interventions/Control_7
Beef rice bowl consisted of 220 g of steamed rice and simmered beef and onions(2625 kJ, P 19.4 g; F 20.4 g; C 87.6 g)
(2) Rice and non-rice were consumed simultaneously (0beef)
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers ,whose body mass index are 16-30 kg/m2
Key exclusion criteria
(1)those who had allergic symptoms to adhesives of continuous glucose monitoring sensors
(2)those with a history of gastrointestinal tract surgery
(3)those who were pregnant or potentially pregnant.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kuwata |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Endocrinology and Metabolism
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
06-6458-5821
kuwata-kob@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kuwata |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Endocrinology and Metabolism
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
06-6458-5821
Homepage URL
kuwata-kob@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Electric Power Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Electric Power Hospital
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
Tel
06-6458-5821
kuwata-kob@umin.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
| 2022 | Year | 03 | Month | 15 | 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
| 2021 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | 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
| 2022 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053762
