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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027032
Receipt No. R000030990
Scientific Title Effects of long-term ingestion of protein-rich milk on muscle strength in university students
Date of disclosure of the study information 2017/04/19
Last modified on 2018/04/10

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Basic information
Public title Effects of long-term ingestion of protein-rich milk on muscle strength in university students
Acronym Effects of ingestion of protein-rich milk on muscle strength
Scientific Title Effects of long-term ingestion of protein-rich milk on muscle strength in university students
Scientific Title:Acronym Effects of ingestion of protein-rich milk on muscle strength
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of 10 weeks ingestion of protein-rich milk and soy protein on muscle strength in university students
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximal isometric muscle strength (after 10 weeks ingestion and change in 10 weeks)
Key secondary outcomes Leg extension strength, grip strength, lean body mass, Fat mass, muscle thickness, muscle activation efficiency, feeling of fatigue (after 10 weeks ingestion and change in 10 weeks)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 10 weeks ingestion of protein-rich milk (107 kcal, 10.0 g protein, 9.5 g carbohydrate, 3.2 g fat/bottle; 2 bottles/day)
Interventions/Control_2 10 weeks ingestion of soy protein (107 kcal, 10.0 g protein, 15.3 g carbohydrate, 0.7 g fat/bottle; 2 bottles/day)
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 and Female
Key inclusion criteria 1) Subjects giving written informed consent
2) University students who belong to sports clubs
Key exclusion criteria 1) Seriously or progressive ill patients
2) Patients with milk, soy or wheat allergies
3) Phenylketonuria patients
4) Subjects who were judged as unsuitable for this study by the doctor for other reasons
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Aoyanagi
Organization Nippon Sport Science University
Division name Faculty of Sport Science
Zip code
Address 1221-1 Kamoshida-cho, Aoba-ku, Yokohama, Kanagawa 227-0033, Japan
TEL +81-45-963-7951
Email aoyanagi@nittai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiaki Sanbongi
Organization Meiji Co., Ltd.
Division name Sports Nutrition Research Department Food Science Research Laboratories R&D Division
Zip code
Address 540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL +81-465-37-3796
Homepage URL
Email chiaki.sanbongi@meiji.com

Sponsor
Institute Meiji Co., Ltd.
Institute
Department

Funding Source
Organization Meiji Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Edihas Co., Ltd.
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
2017 Year 04 Month 19 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
2017 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 20 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
2017 Year 04 Month 18 Day
Last modified on
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030990

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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