UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of endurance training on ectopic fat accumulation and serum vitamin D concentration
Title of the study (Brief title)	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	Mitsuru Higuchi
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL	+81-4-2947-6745
Email	mhiguchi@waseda.jp

Public contact
Name of contact person	Sun Xiaomin
Organization	Waseda University
Division name	Graduate School of Sport Sciences
Address	135-1 Horinouchi, Tokorozawa, Saitama 359-1165
TEL	+81-4-2947-6833
Homepage URL
Email	gzhtxiaomin@ruri.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 10 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
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022105