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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036036
Receipt No. 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 2019/02/28

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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
Email 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
Email ominaomi@taiiku.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email

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 Completed
Date of protocol fixation
2014 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 31 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
2019 Year 02 Month 28 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040876

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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