UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000056926 |
|---|---|
| Receipt number | R000065054 |
| Scientific Title | Examining the effects of food temperature on postprandial blood glucose, absorption, and metabolism |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/02/04 11:28:14 |
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Basic information
Public title
Examining the effects of food temperature on postprandial blood glucose, absorption, and metabolism
Acronym
Examining the effects of food temperature on blood glucose metabolism
Scientific Title
Examining the effects of food temperature on postprandial blood glucose, absorption, and metabolism
Scientific Title:Acronym
Examining the effects of food temperature on blood glucose metabolism
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of food temperature on postprandial blood glucose levels in terms of digestion and absorption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose
Key secondary outcomes
Gastric emptying rate, sugar absorption, appetite, exhaled hydrogen, exhaled oxygen intake and carbon dioxide emissions, body temperature, nutrient intake, international standardized physical activity questionnaire, living conditions
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Consume the test meal at a hot temperature.
Interventions/Control_2
Consume the test meal at cold temperatures.
Interventions/Control_3
Consume the test meal at about body temperatures.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 People who do not suffer from gastrointestinal organ disorders or related diseases
2 People who are not using pacemakers or medical implants
3 People who are not pregnant
4 People who are not taking any medication that affects appetite
5 People who are not allergic to any of the ingredients (rice or wheat) of the test food to be used.
6 A person who is an adult between the ages of 18 and 65 years old
Key exclusion criteria
1 Persons suffering from disorders of the gastrointestinal organs or related diseases
2 People with pacemakers or medical implants
3 People who are pregnant
4 Persons taking medication that affects appetite
5 People who are allergic to the ingredients (rice or wheat) of the test meal to be used.
6 People other than adults between the ages of 18 and 65
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Fujihira |
Organization
Tokyo University of Technology
Division name
Department of Liberal Arts
Zip code
1920982
Address
1404-1 Katakura-cho, Hachioji-shi, Tokyo
TEL
042-637-2768
fujihirak@stf.teu.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Fujihira |
Organization
Tokyo University of Technology
Division name
Department of Liberal Arts
Zip code
1920982
Address
1404-1 Katakura-cho, Hachioji-shi, Tokyo
TEL
042-637-2768
Homepage URL
fujihirak@stf.teu.ac.jp
Sponsor or person
Institute
Tokyo University of Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Tokyo University of Technology Ethics Committee
Address
1404-1 Katakura-cho, Hachioji-shi, Tokyo
Tel
042-637-2210
rinri@stf.teu.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
| 2025 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065054
