UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019117 |
|---|---|
| Receipt number | R000022105 |
| Scientific Title | Effects of endurance training on ectopic fat accumulation and serum vitamin D concentration |
| Date of disclosure of the study information | 2015/09/25 |
| Last modified on | 2017/07/22 13:30:51 |
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Basic information
Public title
Effects of endurance training on ectopic fat accumulation and serum vitamin D concentration
Acronym
Effects of endurance training on serum vitamin D concentration
Scientific Title
Effects of endurance training on ectopic fat accumulation and serum vitamin D concentration
Scientific Title:Acronym
Effects of endurance training on serum vitamin D concentration
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate whether endurance training modulates ectopic fat accumulation, circulating vitamin D concentration, and glucose and lipid profiles in healthy elderly subjects.
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 vitamin D concentration, and glucose and lipid profiles
Key secondary outcomes
Effects of 5-week endurance exercise on maximal oxygen uptake and obesity-related indicators
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
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
One group 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_2
No endurance training during the 5 weeks period.
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
1.Use of tanning booths or other artificial UV light exposure
2.History or presence of diabetes, heart, liver and kidney diseases, and stoke, eating disorders, gastrointestinal disorders
3.Taking vitamin D supplement or 1,25 vitamin D
4.Physician has placed a restriction on physical exercise
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Higuchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
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 | |
| Middle name | |
| Last name | Sun Xiaomin |
Organization
Waseda University
Division name
Graduate School of Sport Sciences
Zip code
Address
135-1 Horinouchi, Tokorozawa, Saitama 359-1165
TEL
+81-4-2947-6833
Homepage URL
gzhtxiaomin@ruri.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
1.The ministry of Education, Culture, Sports, Science, and Technology
2.Waseda University
3.Bio-oriented Technology Research Advancement Institution
4.National Natural Science Foundation of China
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan/China
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 09 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022105
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
