UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057448 |
|---|---|
| Receipt number | R000065641 |
| Scientific Title | Effects of food intake-induced lowering of core temperature on various health-related parameters |
| Date of disclosure of the study information | 2025/03/30 |
| Last modified on | 2026/04/10 09:37:42 |
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Basic information
Public title
The effect of food intake on subsequent core temperature
Acronym
The effect of food intake on body temperature
Scientific Title
Effects of food intake-induced lowering of core temperature on various health-related parameters
Scientific Title:Acronym
The effect of food intake on core temperature
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of food intake on body temperature during exercise in a hot environment in healthy young men
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core temperature
Key secondary outcomes
Skin temperature, energy metabolism, ratings of perceived exertion, inflammatory markers, heart rate, thermal sensation, hydration status, subjective appetite
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants consume the test foods 1 in a hot environment. After 30 minutes of sitting rest, in a hot environment, participants perform cycling exercise for 30 minutes at 75% of their maximal oxygen uptake in a hot environment. Participants rest for 30 minutes in a seated position in a normal environment. The primary and secondary outcomes are evaluated over the experimental period.
Interventions/Control_2
Participants consume the test foods 2 in a hot environment. After 30 minutes of sitting rest in a hot environment, participants perform cycling exercise for 30 minutes at 75% of their maximal oxygen uptake in a hot environment. Participants rest for 30 minutes in a seated position in a normal environment. The primary and secondary outcomes are evaluated over the experimental period.
Interventions/Control_3
Participants consume the test foods 3 in a hot environment. After 30 minutes of sitting rest in a hot environment, participants perform cycling exercise for 30 minutes at 75% of their maximal oxygen uptake in a hot environment. Participants rest for 30 minutes in a seated position in a normal environment. The primary and secondary outcomes are evaluated over the experimental period.
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Participants who are aged 18-29 years old
2. Participants who are males
3. Participants who have not chronic diseases
4. Participants who are not having medication (including supplements)
5. Participants who are non-smoker
6. Participants who have not reduced weight in the past 3 months or who will not intend to lose weight within the examination period
7. Participants who are not participating another study
8. Participants who have exercise habit (at least twice a week for 30 min per bout)
9. Participants who have not allergy for the provided test foods
Key exclusion criteria
1. Participants who are not aged 18-29 years old
2. Participants who are females
3. Participants who have chronic diseases
4. Participants who are having medication (including supplements)
5. Participants who are smoker
6. Participants who have reduced weight in the past 3 months or who will intend to lose weight within the examination period
7. Participants who are participating another study
8. Participants who have no exercise habit (at least twice a week for 30 min per bout)
9. Participants who have allergy for the provided test foods
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima,Tokorozawa, Saitama
TEL
04-2947-6774
m.miyashita@waseda.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima,Tokorozawa, Saitama
TEL
04-2947-6774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
1-104 Totsuka-cho, shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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 | 03 | Month | 30 | 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
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | 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 | 03 | Month | 30 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065641
