UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000019407
Receipt number	R000022438
Scientific Title	Timing of exercise affects 24 hours energy metabolism
Date of disclosure of the study information	2015/10/20
Last modified on	2015/10/20 20:49:15

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Basic information

Public title

Timing of exercise affects 24 hours energy metabolism

Acronym

Timing of exercise affects 24 hours energy metabolism

Scientific Title

Timing of exercise affects 24 hours energy metabolism

Scientific Title:Acronym

Timing of exercise affects 24 hours energy metabolism

Region

Japan

Condition

healthy subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To evaluate the difference of exercise timing on energy metabolism

Basic objectives2

Others

Basic objectives -Others

Sports Medicine

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

Energy expenditure, substrate oxidation and respiratory quotient measured using metabolic chamber.
The continuous measurement for 24 hours started after 1 day from intervention.

Key secondary outcomes

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

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Without exercise-(wash out)-Exercise before breakfast-(wash out)-Exercise after lunch-(wash out)-Exercise after dinner

Interventions/Control_2

Without exercise-(wash out)-Exercise before breakfast-(wash out)-Exercise after dinner-(wash out)-Exercise after lunch

Interventions/Control_3

Without exercise-(wash out)-Exercise after lunch-(wash out)-Exercise before breakfast-(wash out)-Exercise after dinner

Interventions/Control_4

Without exercise-(wash out)-Exercise after lunch-(wash out)-Exercise after dinner-(wash out)-Exercise before breakfast

Interventions/Control_5

Without exercise-(wash out)-Exercise after dinner-(wash out)-Exercise before breakfast-(wash out)-Exercise after lunch

Interventions/Control_6

Without exercise-(wash out)-Exercise after dinner-(wash out)-Exercise after lunch-(wash out)-Exercise before breakfast

Interventions/Control_7

Exercise before breakfast-(wash out)-Without exercise-(wash out)-Exercise after lunch-(wash out)-Exercise after dinner

Interventions/Control_8

Exercise before breakfast-(wash out)-Without exercise-(wash out)-Exercise after lunch-(wash out)-Exercise after dinner

Interventions/Control_9

Exercise before breakfast-(wash out)-Exercise after lunch-(wash out)-Without exercise-(wash out)-Exercise after dinner

Interventions/Control_10

Exercise before breakfast-(wash out)-Exercise after lunch-(wash out)-Exercise after dinner-(wash out)-Without exercise

Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

30 years-old >

Gender

Male

Key inclusion criteria

They were recreationally active but untrained (defined as 2-4 days/wk of moderate exercise).

Key exclusion criteria

Smoker, thyroid disease, diabetes, inflammatory bowel disease, kidney failure, liver failure, biliary atresia, pancreatitis, asthma, chronic obstructive pulmonary disease and pancreatic fibrotic cystic disease.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Makoto Satoh

Organization

University of Tsukuba.

Division name

International Institute for Integrative Sleep Medicine.

Zip code

Address

Tennodai 1-1-1, Tsukuba, Ibaraki, Japan

TEL

029-853-5643

Email

mk-satoh@outlook.com

Public contact

Name of contact person

1st name

Middle name

Last name Makoto Satoh

Organization

University of Tsukuba.

Division name

International Institute for Integrative Sleep Medicine.

Zip code

Address

Tennodai 1-1-1, Tsukuba, Ibaraki, Japan

TEL

029-853-5643

Homepage URL

Email

mk-satoh@outlook.com

Sponsor or person

Institute

Doctoral Program in Sports Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba

Institute

Department

Personal name

Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2015 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

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

2014 Year 07 Month 15 Day

Date of IRB

Anticipated trial start date

2014 Year 09 Month 16 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

The number of intervention group is 24.Intervention 11-24 is as follow.

Invervention 11:
Exercise before breakfast-(wash out)-Exercise after dinner-(wash out)-Without exercise-(wash out)-Exercise after lunch

Invervention 12:
Exercise before breakfast-(wash out)-Exercise after dinner-(wash out)-Exercise after lunch-(wash out)-Without exercise

Invervention 13:
Exercise after lunch-(wash out)-Without exercise-(wash out)-Exercise before breakfast-(wash out)-Exercise after dinner

Invervention 14:
Exercise after lunch-(wash out)-Without exercise-(wash out)-Exercise after dinner-(wash out)-Exercise before breakfast

Invervention 15:
Exercise after lunch-(wash out)-Exercise before breakfast-(wash out)-Exercise after dinner-(wash out)-Without exercise

Invervention 16:
Exercise after lunch-(wash out)-Exercise before breakfast-(wash out)-Without exercise-(wash out)-Exercise after dinner

Invervention 17:
Exercise after lunch-(wash out)-Exercise after dinner-(wash out)-Exercise before breakfast-(wash out)-Without exercise

Invervention 18:
Exercise after lunch-(wash out)-Exercise after dinner-(wash out)-Without exercise-(wash out)-Exercise before breakfast

Invervention 19:
Exercise after dinner-(wash out)-Without exercise-(wash out)-Exercise before breakfast-(wash out)-Exercise after lunch

Invervention 20:
Exercise after dinner-(wash out)-Without exercise-(wash out)-Exercise after lunch-(wash out)-Exercise before breakfast

Invervention 21:
Exercise after dinner-(wash out)-Exercise before breakfast-(wash out)-Without exercise-(wash out)-Exercise after lunch

Invervention 22:
Exercise after dinner-(wash out)-Exercise before breakfast-(wash out)-Exercise after lunch-(wash out)-Without exercise

Invervention 23:
Exercise after dinner-(wash out)-Exercise after lunch-(wash out)-Without exercise-(wash out)-Exercise before breakfast

Invervention 24:
Exercise after dinner-(wash out)-Exercise after lunch-(wash out)-Exercise before breakfast-(wash out)-Without exercise

Management information

Registered date

2015 Year 10 Month 19 Day

Last modified on

2015 Year 10 Month 20 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022438

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name