UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032958 |
|---|---|
| Receipt number | R000037578 |
| Scientific Title | Examination of meal freaquency for weight gain program in athletes |
| Date of disclosure of the study information | 2018/06/12 |
| Last modified on | 2018/06/13 19:58:53 |
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Basic information
Public title
Examination of meal freaquency for
weight gain program in athletes
Acronym
Examination of meal freaquency for
weight gain program in athletes
Scientific Title
Examination of meal freaquency for
weight gain program in athletes
Scientific Title:Acronym
Examination of meal freaquency for
weight gain program in athletes
Region
| Japan |
Condition
Condition
Healthy condition
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect for weight gain by
different meal freaquency with positive
energy intake of additional>16~18kcal/kg BW than total energy expenditure as well as
fat energy ratio of less than 30%.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition
Key secondary outcomes
Body weight
Blood biochemical parameter
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
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Intervention priod:8 weeks
Meal freaquency: three times per day
Energy intalke:additional>1000kcal
(appropriayely>18kcal/kgBW) energy of meals on the total energy expenditure
Fat ratio of energy intake:less than 30%
Interventions/Control_2
ntervention priod:8 weeks
Meal freaquency: six times per day
Energy intalke:additional>1000kcal
(appropriayely>18kcal/kgBW) energy of meals on the total energy expenditure
Fat ratio of energy intake:less than 30%
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
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
Collegiate athletes required weight gain
Key exclusion criteria
With gastrointestinal symptom
With gastrointestinal disease
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Taguchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6778
mtaguchi@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Murata |
Organization
Waseda University
Division name
Organization for University Reserch Initiative
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6778
Homepage URL
hmurata567@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Self Funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 06 | Month | 12 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 12 | Day |
Last modified on
| 2018 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037578
