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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
