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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044171
Receipt No. R000050440
Scientific Title The importance of breakfast intake on the physical development in young men - focusing on the protein metabolism -
Date of disclosure of the study information 2021/05/17
Last modified on 2021/05/11

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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
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 Open public recruiting
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
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
2021 Year 05 Month 11 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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