UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044171 |
|---|---|
| Receipt number | 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 | 2022/05/24 19:09:28 |
* 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
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
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
mtaguchi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050440
