UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018972
Receipt number R000021948
Scientific Title Development of an exercise program to improve the drinking effect of fortified milk: focusing on the muscle mass and muscle strength in older adults
Date of disclosure of the study information 2015/09/10
Last modified on 2016/03/13 11:19:12

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Basic information

Public title

Development of an exercise program to improve the drinking effect of fortified milk: focusing on the muscle mass and muscle strength in older adults

Acronym

Development of an exercise and nutritional program to improve muscle function in older adults

Scientific Title

Development of an exercise program to improve the drinking effect of fortified milk: focusing on the muscle mass and muscle strength in older adults

Scientific Title:Acronym

Development of an exercise and nutritional program to improve muscle function in older adults

Region

Japan


Condition

Condition

Decrease muscle mass and decline muscle strength

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop an exercise program to improve drinking effect of fortified milk on muscle mass and muscle strength

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle mass

Key secondary outcomes

1. Muscle strength
2. Physical performance
3. VO2 peak
4. Nutritional status
5. Biochemical blood test
6. Arterial compliance


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food Other

Interventions/Control_1

3-month intervention
1. Resistance training and aerobic training for twice per week.
2. Drinking fortified milk (200 ml) in everyday

Interventions/Control_2

3-month intervention
1. Resistance training for twice per week.
2. Drinking fortified milk (200 ml) in everyday

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

65 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Not restricted by a doctor from exercising
2. Not doing moderate-vigorous-intensity resistance training and aerobic training
3. Not participate in another clinical trial in one year
4. Not have lactose intolerance
5. Can agree with contents of study
6. Not take medication of diabetes

Key exclusion criteria

1. Care-dependent or support-dependent on a Japanese long-term care insurance system
2. Have severe heart disease, cerebrovascular disease, and renal dysfunction
3. Medical doctor can not agree with participation in study
4. Have too much habitual-milk intake
5. Feel knee pain in ecercise

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyoji Tanaka

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan

TEL

+81-29-853-5600(8365)

Email

tanaka@taiiku.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jung Songee

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan

TEL

+81-29-853-5600(8365)

Homepage URL


Email

songeejung@hotmail.com


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

J-milk (Japan Dairy Association)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

筑波大学総合研究棟D


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 10 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

2015 Year 07 Month 02 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 21 Day

Last follow-up date

2015 Year 12 Month 04 Day

Date of closure to data entry

2016 Year 02 Month 29 Day

Date trial data considered complete

2016 Year 03 Month 25 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 10 Day

Last modified on

2016 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021948


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name