UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of effects of meal timing on energy metabolism
Acronym	Elucidation of effects of meal timing on energy metabolism
Scientific Title	Effects of meal timing on energy metabolism
Scientific Title:Acronym	Effects of meal timing on energy metabolism
Region	Japan

Condition
Condition	Adult men
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify effects of meal timing on each component of energy expenditure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	24-hours glucose concentration
Key secondary outcomes	Glucose concentration indices, 24-hours glucose standard deviation. energy expenditure substrate oxidation physical activity Appetite, visual analogue scale

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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	1. Control meal time (breakfast:7:30-8:30, lunch: 12:00-13:00, dinner:19:00-20:00). Wash out 1 week. 2. Night type meal time(lunch:11:30-13:30, dinner:16:00-17:00, midnight meal: 23:00-0:00)
Interventions/Control_2	1. Night type meal time(lunch: 11:30-13:30, dinner: 16:00-17:00, midnight snack: 23:00-0:00). Wash out 1 week. 2. Control meal time(breakfast: 7:30-8:30, lunch:12:00-13:00, dinner:19:00-20:00).
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	40 years-old >
Gender	Male
Key inclusion criteria	1. Subjects who can make self-judgment and are voluntarily giving written informed consent. 2. BMI range: 18.5-30.0 kg/m2 3. Healthy subjects 4. Who is approved participation by the doctor
Key exclusion criteria	1. BMI range: 18.5-30.0 kg/m2 2. Who are not prohibited from exercising by a doctor. 3. Subjects who have diagnostic of mental disorder 4. Subjects who have past surgical history of gastroenterological surgery. 5. Past medical history of kidney disease. 6. Subjects who use pharmaceuticals regularly. 7. Subjects who excessive alcohol intake and who have a smoking habit. 8. Subjects who is irregular eating habits. 9. Subjects who are participating or will participate other clinical trials. 10. Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Yoichi Middle name Last name Hatamoto
Organization	National Institute of Health, and Nutrition, National Institutes of Biomedical Innovation, Health, and Nutrition
Division name	Department of Nutrition and Metabolism
Zip code	1628636
Address	1-23-1 Toyama, Shinjuku-ku
TEL	+81332035725
Email	yhatamoto@nibiohn.go.jp

Public contact
Name of contact person	1st name YOICHI Middle name Last name HATAMOTO
Organization	Fukuoka University
Division name	Institute for Physical Activity
Zip code	8140180
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	+81928716631
Homepage URL
Email	yhatamoto@nibiohn.go.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	JSPS KAKENHI
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	same as above
Address	same as above
Tel	0928716631
Email	pj.ca.u-akoukuf.mda@nisius

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	2022 Year 07 Month 01 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	8
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 05 Month 03 Day
Date of IRB	2018 Year 05 Month 16 Day
Anticipated trial start date	2018 Year 05 Month 03 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	2022 Year 07 Month 01 Day
Last modified on	2022 Year 07 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054953