UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018374 |
|---|---|
| Receipt number | R000021274 |
| Scientific Title | Elucidation of effects of endurance training on ectopic fat accumulation, novel peptide hormone, gut microbiota and the individual responsiveness |
| Date of disclosure of the study information | 2015/07/22 |
| Last modified on | 2024/11/23 14:50:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Elucidation of effects of endurance training on ectopic fat accumulation, novel peptide hormone, gut microbiota and the individual responsiveness
Acronym
Effects of endurance training on health status
Scientific Title
Elucidation of effects of endurance training on ectopic fat accumulation, novel peptide hormone, gut microbiota and the individual responsiveness
Scientific Title:Acronym
Effects of endurance training on health status
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study was to evaluate whether endurance training modulates ectopic fat accumulation, circulating peptide hormone level, arterial wall stiffness and gut microbiota in healthy elderly subjects, and the individual responsiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of 5-week endurance exercise on hepatic fat content, circulating peptide hormone level, arterial wall stiffness and gut microbiota, and association between these outcomes and genetic polymorphism
Key secondary outcomes
Effects of 5-week endurance exercise on maximal oxygen uptake, obesity index and blood biochemical parameters
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants undertook a progressive aerobic exercise program for 5 weeks. Training comprised three cycle ergometer sessions (30-45 minutes each) per week, and the intensity gradually increased from 60 to 75% of maximal oxygen uptake. After the exercise intervention, the subjects switched to rest period for a 5 weeks.
Interventions/Control_2
After a 5-week rest period, participants undertook a progressive aerobic exercise program for 5 weeks. Training comprised three cycle ergometer sessions (30-45 minutes each) per week, and the intensity gradually increased from 60 to 75% of maximal oxygen uptake.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
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
The Ministry of Education, Culture, Sports, Science, and Technology. Waseda University. Bio-oriented Technology Research Advancement Institution, NARO.
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
https://academic.oup.com/jcem/article/101/1/191/2806705?login=false
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/jcem/article/101/1/191/2806705?login=false
Number of participants that the trial has enrolled
33
Results
A 5-week endurance exercise program decreased the hepatic fat content and serum FGF21 levels without weight loss, and the changes were higher in the exercise period than in the control period (P = .021 and P = .026, respectively). Correlation analysis demonstrated that only the change in hepatic fat content was significantly and positively correlated with change in serum FGF21 levels (r = 0.366, P = .006).
Results date posted
| 2024 | Year | 11 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elderly Japanese men (aged 62-76 years)
Participant flow
Participants were recruited from temporary employment agencies.The subjects were randomized by an independent observer to either a 5-week endurance exercise program or a control period during which they were instructed not to undertake any formal exercise or change their level of general physical activity. After 5 weeks, the subjects switched to the other regimen for 5 weeks.
Adverse events
One subject did not complete the exercise program because he was injured in a car crash that was not related to this study.
Outcome measures
Cardiorespiratory fitness level, anthropometric characteristics, and blood analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 21 | 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=R000021274
