UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036994 |
|---|---|
| Receipt number | R000042147 |
| Scientific Title | Effects of endurance exercise performed in the morning and evening on metabolic response and circadian rhythm. |
| Date of disclosure of the study information | 2019/06/07 |
| Last modified on | 2023/09/29 12:58:56 |
* 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
Effects of endurance exercise performed in the morning and evening on metabolic response and circadian rhythm.
Acronym
Effects of endurance exercise performed in the morning and evening on metabolic response and circadian rhythm.
Scientific Title
Effects of endurance exercise performed in the morning and evening on metabolic response and circadian rhythm.
Scientific Title:Acronym
Effects of endurance exercise performed in the morning and evening on metabolic response and circadian rhythm.
Region
| Japan |
Condition
Condition
Obesity, Diabetes
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare the effects of endurance exercise training performed in the morning and evening on metabolic response and circadian rhythm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following measures would be conducted before and after 1 weeks of intervention.
1) metabolite and hormone
2)
Key secondary outcomes
1)inflammatory cytokines
2) clock-gene
3) physical activity(accelerometer)
4) morningness-eveningness type, Pittsburgh sleep quality index (questionnaire)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The exercise morning trial (0900 - 1100 h) are asked to do moderate endurance exercise for a 60 min/session 3 d per week for 1 weeks.
Interventions/Control_2
The exercise evening trial (1600 - 2000 h) are asked to do moderate endurance exercise for a 60 min/session 3 d per week for 1 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Gives informed consent, agrees to be randomly assigned
Key exclusion criteria
1) Physically active lifestyle
2) Intake of lipid and/or glucose lowering medication
3) Intake of Antipsychotics, Hypnotic, Steroids
4) Judged ineligible by a medical doctor.
5) Obesity (BMI>34kg/m2) and sleep apnea syndrome
6) High blood pressure (SBP: above 140mmHg, and DBP: above 90mmHg)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shigenobu |
| Middle name | |
| Last name | Shibata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
162-8480
Address
2-2 Wakamatsu, Shinjuku, Tokyo
TEL
03-5369-7318
shibatas@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
2-2 Wakamatsu, Shinjuku, Tokyo
TEL
03-5369-7318
Homepage URL
gusrlgusrl82@gmail.com
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 Totuska, Shinjuku, Tokyo
Tel
03-5272-1639
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
| 2019 | Year | 06 | Month | 07 | 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
12
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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042147
