UMIN-CTR Clinical Trial

Basic information
Public title	Effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Acronym	Effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Scientific Title	Effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Scientific Title:Acronym	Effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Region	Japan

Condition
Condition	obesity
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study was to compare the effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The following measures would be conducted before and after 12 weeks of intervention. 1) metabolite and hormone
Key secondary outcomes	2) substrate metabolism 3) body composition 4) clock-gene

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	The exercise morning group (0800 - 1100 h) are asked to do moderate endurance exercise for a 60 min/session 3 d per week for 12 weeks.
Interventions/Control_2	The exercise evening group (1700 - 2000 h) are asked to do moderate endurance exercise for a 60 min/session 3 d per week for 12 weeks.
Interventions/Control_3	Control group are asked to maintain their usual lifestyle during the same period as intervention group.
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	20 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age between 20-79 years 2) Gives informed consent, agrees to be randomly assigned
Key exclusion criteria	1) Patients with a history of cardiovascular disease 2) Physically active lifestyle 3) Intake of lipid and/or glucose lowering medication in the previous 3 months 4) Smoking habit
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shizuo Middle name Last name Sakamoto
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama,359-1192 Japan
TEL	04-2947-4545
Email	s.sakamoto@waseda.jp

Public contact
Name of contact person	1st name Hyeon-Ki Middle name Last name Kim
Organization	Waseda University
Division name	School of Advanced Science and Engineering
Zip code	162-8480
Address	TWIns 1F-C302, 2-2 Wakamatsu-cho, Shinjuku-ku, Tokyo
TEL	03-5369-7318
Homepage URL
Email	hk.kim@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Waseda University
Address	1-104 Totsuka, Shinjuku, Tokyo
Tel	03-5272-1639
Email	rinri@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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 20 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	38
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	Completed
Date of protocol fixation	2016 Year 10 Month 13 Day
Date of IRB	2016 Year 08 Month 31 Day
Anticipated trial start date	2016 Year 10 Month 19 Day
Last follow-up date	2021 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	2016 Year 10 Month 18 Day
Last modified on	2021 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028157