UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021308 |
|---|---|
| Receipt number | R000024576 |
| Scientific Title | Elucidation of effects of acute endurance exercise on novel peptide hormone |
| Date of disclosure of the study information | 2016/03/04 |
| Last modified on | 2024/11/23 15:05:55 |
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Basic information
Public title
Elucidation of effects of acute endurance exercise on novel peptide hormone
Acronym
Elucidation of effects of acute endurance exercise on novel peptide hormone
Scientific Title
Elucidation of effects of acute endurance exercise on novel peptide hormone
Scientific Title:Acronym
Elucidation of effects of acute endurance exercise on novel peptide hormone
Region
| Japan |
Condition
Condition
Healthy males and females
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate whether acute endurance exercise modulates circulating peptide hormone level in healthy young and elderly subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of acute endurance exercise on circulating peptide hormone level
Key secondary outcomes
Effects of acute endurance exercise on blood biochemical parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Young participants undertook an acute aerobic exercise using cycle ergometer. Exercise intensity was 70% of maximal oxygen uptake, and exercise duration was 30 minutes.
Interventions/Control_2
Elderly participants undertook an acute aerobic exercise using cycle ergometer. Exercise intensity was 70% of maximal oxygen uptake, and exercise duration was 30 minutes.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy young subjects over 18 years old, and healthy elderly subjects over 60 years old
Key exclusion criteria
Subject who could not perform exercise and/or who have chronic diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Higuchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL
+81-4-2947-6745
mhiguchi@waseda.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Taniguchi |
Organization
Waseda University
Division name
Graduate School of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL
+81-4-2947-6745
Homepage URL
hirokazu-t@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for JSPS Fellows. A Waseda University Grant. The Council for Science, Technology and Innovation, SIP, "Technologies for creating next-generation agriculture, forestry and fisheries".
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
+81-3-5272-4652
rps-management@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
早稲田大学 (Waseda University)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/abs/10.1111/cen.13162
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1111/cen.13162
Number of participants that the trial has enrolled
28
Results
Higher serum FGF21 was observed in the elderly subjects group throughout the experiment (P < 0.05). There was no significant increase in serum FGF21 levels after the cessation of exercise, whereas serum FGF21 levels were significantly lower 24 h after the exercise compared with those pre-exercise, 0 min, 30 min and 1 h after the cessation of exercise in both groups (P < 0.01).
Results date posted
| 2024 | Year | 11 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ten healthy young male (age: 18-22 years), nine young female (age: 19-22 years) and nine elderly male (age: 62-69 years) subjects were selected for this study.
Participant flow
The participants arrived at the laboratory between 8:30 and 9:30 AM after an overnight fast, and preexercise blood samples were drawn. The participants consumed 180 kcal of carbohydrate energy jelly before commencing exercise. After a 5-min warm-up at 45-90 W, the participants performed a cycling exercise for 30 min at 70% VO2max. Blood samples were collected immediately after the exercise and at 30 min, 1 h and 3 h after the acute exercise session. On the following day, blood samples were collected from the participants between 8:30 and 9:30 AM after an overnight fast.
Adverse events
None
Outcome measures
Anthropometric measurements, maximal oxygen uptake, and blood analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024576
