UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022393
Receipt number R000025753
Scientific Title Effects of long-term ingestion of milk protein on body composition and physical capacity in high school students
Date of disclosure of the study information 2016/05/23
Last modified on 2016/11/21 08:49:31

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Basic information

Public title

Effects of long-term ingestion of milk protein on body composition and physical capacity in high school students

Acronym

Effects of long-term ingestion of milk protein on body composition and physical capacity in high school students

Scientific Title

Effects of long-term ingestion of milk protein on body composition and physical capacity in high school students

Scientific Title:Acronym

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

1st name
Middle name
Last name Shuji Ikegami

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

Email

shuuji.ikegami@meiji.com


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 or person

Institute

Meiji Co., Ltd.

Institute

Department

Personal name



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)



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

2016 Year 05 Month 23 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

2016 Year 03 Month 24 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025753


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name