UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of long-term ingestion of milk protein on body composition and physical capacity in high school students
Title of the study (Brief title)	Effects of long-term ingestion of milk protein on body composition and physical capacity in high school students
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 12 weeks ingestion of milk protein drinks and control drinks on body composition and physical capacity in high school students
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skeletal muscle mass (after 12 weeks ingestion and change in 12 weeks)
Key secondary outcomes	Body height, body weight, body fat mass, time of 50 m dash, standing long jump length, throwing medicine ball length, grip strength, back muscle strength, leg extension strength, leg muscle thickness, feeling of fatigue (after 12 weeks ingestion and change in 12 weeks)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	12 weeks ingestion of milk protein drinks (107 kcal, 10 g protein, 9.5 g carbohydrate, 3.2 g fat/bottle; 2 bottles/day)
Interventions/Control_2	12 weeks ingestion of control drinks (104 kcal, 0.0 g protein, 26 g carbohydrate, 0.0 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	15 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Subjects giving written informed consent 2) High school students who belong to sports clubs
Key exclusion criteria	1) Seriously or progressive ill patients 2) Patients with milk or grape allergies 3) 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	Shuji Ikegami
Organization	Meiji Co., Ltd.
Division name	Sports Nutrition Research Department Food Science Research Laboratories R&D Division
Address	540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL	+81-465-37-3796
Email	shuuji.ikegami@meiji.com

Public contact
Name of contact person	Chiaki Sanbongi
Organization	Meiji Co., Ltd.
Division name	Sports Nutrition Research Department Food Science Research Laboratories R&D Division
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	Bell Medical Solutions Inc.
Name of secondary funｄer(s)

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	2016 Year 05 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 24 Day
Anticipated trial start date	2016 Year 06 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 20 Day
Last modified on	2016 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025753