UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048617 |
|---|---|
| Receipt number | R000055394 |
| Scientific Title | Efficacy of nutrition lecture on dietary basics for athletes: a randomized controlled trial |
| Date of disclosure of the study information | 2022/08/07 |
| Last modified on | 2023/11/21 13:21:23 |
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Basic information
Public title
Efficacy of nutrition lecture on dietary basics for athletes: a randomized controlled trial
Acronym
Efficacy of nutrition lecture for athletes
Scientific Title
Efficacy of nutrition lecture on dietary basics for athletes: a randomized controlled trial
Scientific Title:Acronym
Efficacy of nutrition lecture for athletes
Region
| Japan |
Condition
Condition
Healthy athlete
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the efficacy of nutrition lecture on the dietary basics for athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The Japanese Food Guide adherence score
Key secondary outcomes
Energy and nutrient intakes
Nutritional knowledge
Stages of change in eating behavior
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
No intervention
Interventions/Control_2
A single nutrition lecture and provision of materials
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Male and female university students aged 20-30 years
A member of a university sports club
Being dedicated to sports activities
Key exclusion criteria
Receiving continuous nutritional support (such as nutrition lecture or consulting more than once a month)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryoko |
| Middle name | |
| Last name | Mizushima |
Organization
Japan Sport Council
Division name
Japan Institute of Sport Sciences
Zip code
115-0056
Address
3-15-1 Nishigaoka, Kita-ku, Tokyo 115-0056, Japan
TEL
03-5963-0231
ryoko.mizushima@jpnsport.go.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Mizushima |
Organization
Japan Sport Council
Division name
Japan Institute of Sport Sciences
Zip code
115-0056
Address
3-15-1 Nishigaoka, Kita-ku, Tokyo 115-0056, Japan
TEL
03-5963-0231
Homepage URL
ryoko.mizushima@jpnsport.go.jp
Sponsor or person
Institute
Japan Institute of Sports Sciences, Japan Sport Council
Institute
Department
Personal name
Funding Source
Organization
Japan Institute of Sports Sciences, Japan Sport Council
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Institute of Sports Sciences, Japan Sport Council
Address
3-15-1 Nishigaoka, Kita-ku, Tokyo 115-0056, Japan
Tel
03-5963-0202
research-01@jpnsport.go.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
筑波大学 / University of Tsukuba
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055394
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
