UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059352 |
|---|---|
| Receipt number | R000067882 |
| Scientific Title | Effect of Breakfast Protein Intake on Body Composition and Performance in Athletes |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/10/09 11:22:27 |
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Basic information
Public title
How Protein Intake at Breakfast affects Body Composition and Performance in Athletes
Acronym
Breakfast Protein Intake and Athletes' Performance and Body Composition
Scientific Title
Effect of Breakfast Protein Intake on Body Composition and Performance in Athletes
Scientific Title:Acronym
Effect of Breakfast Protein in Athletes
Region
| Japan |
Condition
Condition
Collegiate Athletes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine how increasing protein intake at breakfast affects body composition and performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass, Muscle strength
Key secondary outcomes
Subjective fatigue
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Participants are asked to consume powdered protein at breakfast for 12 weeks.
Interventions/Control_2
Participants are asked to consume powdered protein at dinner for 12 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Collegiate athletes with adequate total daily protein intake (1.4 g/kg body weight/day) but insufficient breakfast protein intake (0.31 g/kg body weight)
Key exclusion criteria
Athletes not participating in training due to injury or other reasons, Individuals with milk allergies
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Ishikawa-Takata |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
1158650
Address
1-7-11 Akabanedai, Kita-ku, Tokyo 115-8650
TEL
03-5924-2835
takata001@toyo.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Ishikawa-Takata |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
1158650
Address
1-7-11 Akabanedai, Kita-ku, Tokyo 115-8650
TEL
0359242835
Homepage URL
takata001@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Toyo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Promotion Section, Toyo University
Address
2100 Kujirai, Kawagoe, Saitama
Tel
0492391440
mlkks@toyo.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
| 2025 | Year | 10 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067882
