UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062173 |
|---|---|
| Receipt number | R000071149 |
| Scientific Title | A Longitudinal Intervention Study on the Physical and Psychological Effects of Egg Intake in University Long-Distance Runners |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/08 17:00:37 |
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Basic information
Public title
A Longitudinal Intervention Study on the Physical and Psychological Effects of Egg Intake in University Long-Distance Runners
Acronym
Effects of Egg Intake in Collegiate Long-Distance Runners
Scientific Title
A Longitudinal Intervention Study on the Physical and Psychological Effects of Egg Intake in University Long-Distance Runners
Scientific Title:Acronym
Effects of Egg Intake in Collegiate Long-Distance Runners
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will longitudinally examine (1) the effects of post-training egg consumption on iron metabolism and mood state, (2) the impact on spontaneous dietary behavior following the intervention, (3) a comparison with conditions where consumption timing is not restricted, and (4) the relationship between the burden of consumption and adherence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Subjective Measures] Conducted via self-administered paper-based surveys
Profile of Mood States 2 Short Form (POMS2-SF): Fatigue scale
Visual Analog Scale (VAS): Fatigue, concentration, and physical condition
Questionnaire survey evaluating egg consumption using a 5-point scale across the following dimensions: psychological aspects, taste and preferences, practical aspects, physical aspects, and willingness to continue consumption.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume two eggs after training or at any time of day.
Interventions/Control_2
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
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
University student and member of the track and field team
Aged 18-22
No egg allergy
Key exclusion criteria
Restricting egg intake
Individuals instructed by a doctor to follow dietary restrictions
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Namie |
| Middle name | |
| Last name | Kojima |
Organization
Kyoto Koka University
Division name
Department of Health and Nutrition / Institute of Food Creation
Zip code
615-0882
Address
38, Kadono-cho, Nshikyogoku, Ukyo-ku, Kyoto, JAPAN
TEL
075-874-7246
n-kojima@mail.koka.ac.jp
Public contact
Name of contact person
| 1st name | Namie |
| Middle name | |
| Last name | Kojima |
Organization
Kyoto Koka University
Division name
Department of Health and Nutrition / Institute of Food Creation
Zip code
615-0882
Address
38, Kadono-cho, Nshikyogoku, Ukyo-ku, Kyoto, JAPAN
TEL
075-874-7246
Homepage URL
n-kojima@mail.koka.ac.jp
Sponsor or person
Institute
Kyoto Koka University
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Kyoto Koka University
Address
38, Kadono-cho, Nshikyogoku, Ukyo-ku, Kyoto, JAPAN
Tel
075-874-7246
n-kojima@mail.koka.ac.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
| 2026 | Year | 07 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071149
