UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058161 |
|---|---|
| Receipt number | R000066480 |
| Scientific Title | Responses of circulating FABP4, glucose metabolism, and inflammation to continuous and interval exercise |
| Date of disclosure of the study information | 2025/06/13 |
| Last modified on | 2025/06/12 13:45:15 |
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Basic information
Public title
Responses of circulating FABP4, glucose metabolism, and inflammation to acute exercise
Acronym
Acute exercise and fatty acid-binding protein 4, glucose metabolism, and inflammation
Scientific Title
Responses of circulating FABP4, glucose metabolism, and inflammation to continuous and interval exercise
Scientific Title:Acronym
Continuous and interval exercise and fatty acid-binding protein 4, glucose metabolism, and inflammation
Region
| Japan |
Condition
Condition
A healthy population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the associations of circulating fatty acid-binding protein 4, glucose metabolism, and inflammatory responses with continuous and intermittent acute exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Fatty acid binding protein 4
Key secondary outcomes
glucagon
adropin
Interleukin-6
Interleukin-1beta
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
acute interval exercise
Interventions/Control_2
acute continuous exercise
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
2. Not regularly performing exercise training
3. Can agree with the contents of the study
Key exclusion criteria
1. Current smoker
2. Taking medicines and supplements affecting metabolism
3. Restricted exercise training
4. Having a current or history of cardiovascular diseases
5. Having a weight change of more than 3 kg within the past 6 months
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shigeharu |
| Middle name | |
| Last name | Numao |
Organization
National Institute of Fitness and Sports in Kanoya
Division name
Department of Sports and Life Science
Zip code
891-2393
Address
1 Shiromizu, Kanoya, Kagoshima, Japan
TEL
+81-994-46-4946
numashige@nifs-k.ac.jp
Public contact
Name of contact person
| 1st name | Shigeharu |
| Middle name | |
| Last name | Numao |
Organization
National Institute of Fitness and Sports in Kanoya
Division name
Department of Sports and Life Science
Zip code
891-2393
Address
1 Shiromizu, Kanoya, Kagoshima, Japan
TEL
+81-994-46-4946
Homepage URL
numashige@nifs-k.ac.jp
Sponsor or person
Institute
National Institute of Fitness and Sports in Kanoya
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
National Institute of Fitness and Sports in Kanoya
Address
1 Shiromizu, Kanoya, Kagoshima, Japan
Tel
+81-994-46-4878
kokusai@nifs-k.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
鹿屋体育大学（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 13 | 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 | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2028 | 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 | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066480
