UMIN-CTR Clinical Trial

Basic information
Public title	Effects of exercise and milk protein drink ingestion on muscle mass and strength in elderly people
Acronym	Effects of exercise and milk protein drink ingestion on muscle mass and strength in elderly people
Scientific Title	Effects of exercise and milk protein drink ingestion on muscle mass and strength in elderly people
Scientific Title:Acronym	Effects of exercise and milk protein drink ingestion on muscle mass and strength in elderly people
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effects of 6 months ingestion of milk protein drink following exercise on muscle mass and strength in people aged 60 or more compared to placebo drink.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Isokinetic muscle strength (knee extension and flexion)
Key secondary outcomes	Grip strength, push up, walking speed, timed "Up & Go" test, sit-to-stand test, functional reach, body weight, lean body mass, fat mass, segmental lean mass, muscle thickness, blood analysis, executive function, blood pressure, pulse rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	6 months ingestion of milk protein drink (68 kcal, 10.1 g protein, 7.0 g carbohydrate, 0.2 g fat/day) and exercise
Interventions/Control_2	6 months ingestion of placebo drink (68 kcal, 0.1 g protein, 16.0 g carbohydrate, 0.5 g fat/day) and exercise
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Able to provide written consent and understand the study requirements and procedures 2) Age 60 or more
Key exclusion criteria	1) Significant kidney, liver, respiratory, cardiovascular or digestive disease 2) Significant orthopedic injury 3) Milk or soy allergies 4) Significant abnormal value of blood pressure or pulse rate 5) Significant abnormal value of blood test 6) Protein restriction 7) Resistance training (3 days/week or more and 30 min/day or more) 8) Not submit first dietary records 9) Participate in other study 10) Judged as unsuitable for this study by the doctor for other reasons
Target sample size	120

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Tadasu Urashima
Organization	Obihiro University of Agriculture & Veterinary Medicine
Division name	Graduate School of Food Hygiene
Zip code
Address	Nishi2sen 11banchi, Inada cho, Obihiro, Hokkaido 080-8555, Japan
TEL	+81-155-49-5577
Email	urashima@obihiro.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Chiaki Sanbongi
Organization	Meiji Co., Ltd.
Division name	Food Science & Technology Research Laboratories
Zip code
Address	1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919, Japan
TEL	+81-42-632-5846
Homepage URL
Email	chiaki.sanbongi@meiji.com

Sponsor
Institute	Obihiro University of Agriculture & Veterinary Medicine
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	帯広畜産大学

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 11 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	2018 Year 02 Month 09 Day
Date of IRB	2018 Year 02 Month 09 Day
Anticipated trial start date	2018 Year 05 Month 09 Day
Last follow-up date	2018 Year 11 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 10 Day
Last modified on	2019 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036715