UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036036 |
|---|---|
| Receipt number | R000040876 |
| Scientific Title | Effects of supplementary protein powder on American football players' body composition |
| Date of disclosure of the study information | 2019/02/28 |
| Last modified on | 2021/01/05 09:55:17 |
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Basic information
Public title
Effects of supplementary protein powder on American football players' body composition
Acronym
Protein powder study
Scientific Title
Effects of supplementary protein powder on American football players' body composition
Scientific Title:Acronym
Protein powder study
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of consuming EMIQ with supplementary protein powder on American football players' changes in body composition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Body composition parameters using DXA (0,4 month)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test group
Duration: 4 months, 6 times a week
Test material: supplementary protein powder with EMIQ
Interventions/Control_2
Placebo group:
Duration: 4 months, 6 times a week
Test material: supplementary protein powder
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
Key inclusion criteria
Male Japanese students who played American football(BMI >=18.5 and <30)
Key exclusion criteria
Subject with food allergy.
Subject who consumes other supplementary protein powder, drug or supplement during the study.
Subject who changes lifestyle, including dietary and exercise habit, during the study.
Subject who eats unbalanced diet (consuming much polyphenol-rich food, such as citrus fruit, buckwheat, and fermented soybeans), and consumes excessive alcohol.
Subject who refrained from practice for long periods (e.g., because of injury).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Omi |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1, Tennou dai, Tsukuba city
TEL
029-853-6319
ominaomi@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Omi |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1, Tennou dai, Tsukuba city
TEL
029-853-6319
Homepage URL
ominaomi@taiiku.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Morinaga & Co., Ltd.
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
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
| 2019 | Year | 02 | Month | 28 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040876
| Research Plan | |
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| 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 |
