UMIN-CTR Clinical Trial

Basic information
Public title	The effect of breakfast intake on the physical development in young men
Acronym	The effect of breakfast intake on the physical development
Scientific Title	The importance of breakfast intake on the physical development in young men - focusing on the protein metabolism -
Scientific Title:Acronym	The importance of breakfast intake on the physical development in young men
Region	Japan

Condition
Condition	Young men
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of breakfast intake on protein metabolism in young men
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in amino acid utilization over time
Key secondary outcomes	3-methyl histidine in urea Blood parameters

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intervention period: 1 week Meal timing: at lunch and dinner, adjusted by energy availability to 30 kcal/kg FFM/day
Interventions/Control_2	Intervention period: 1 week Meal timing: at breakfast, lunch and dinner, adjusted by energy availability to 45 kcal/kg FFM/day
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	30 years-old >
Gender	Male
Key inclusion criteria	1. Male subjects who are aged 20-29 years old 2. Subjects who have a habit of breakfast skipping 3. Subjects whose physical activity status does not change drastically during intervention periods 4. Subjects who obtained the consent to the study
Key exclusion criteria	1. Subjects who take medicines of metabolism and hormone 2. Subjects who are smokers 3. Subjects who are controlling their body weight 4. Subjects who have food allergies and are unable to consume the provided meals
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Motoko Middle name Last name Taguchi
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL	04-2947-6778
Email	mtaguchi@waseda.jp

Public contact
Name of contact person	1st name Motoko Middle name Last name Taguchi
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL	04-2947-6778
Homepage URL
Email	mtaguchi@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	MEXT
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	Ethics Review Committee on Research with Human Subjects, Waseda University
Address	1-104, Totsuka-cho, Shinjuku-ku, 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	2021 Year 05 Month 17 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	16
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	2021 Year 04 Month 07 Day
Date of IRB	2021 Year 04 Month 07 Day
Anticipated trial start date	2021 Year 04 Month 13 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 05 Month 24 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 11 Day
Last modified on	2022 Year 05 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050440