UMIN-CTR Clinical Trial

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
Email	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
Email	kuwata-kob@umin.ac.jp

Sponsor
Institute	Kansai Electric Power Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053762