UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024544
Receipt number R000028248
Scientific Title Effects of milk product intake on improvements of QOL and physical fitness in elderly people
Date of disclosure of the study information 2016/10/24
Last modified on 2016/10/24 17:48:08

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Basic information

Public title

Effects of milk product intake on improvements of QOL and physical fitness in elderly people

Acronym

Effects of milk product intake in elderly people

Scientific Title

Effects of milk product intake on improvements of QOL and physical fitness in elderly people

Scientific Title:Acronym

Effects of milk product intake in elderly people

Region

Japan


Condition

Condition

Age-associated diseases

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To examine the effects of exercise training + milk product intake on the improvements of physical fitness, glucose tolerance, body temperature regulation, and the symptons of lifstyle-related diseases together with the epigenetic effects of inflammatory genes in elderly people.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

physical fitness, glucose tolerance, body temperature regulation, the symptons of lifestyle-related diseases, and the methylation of inflammatory genes

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Interval walking training + no milk product intake. Subjects perform interval walking training; repeating more than 5 sets of fast walking, equivalent to more than 70% of peak aerobic capacity, and slow walking, equivalent to ~40% peak aerobic capacity, for 3 min each per day, for more than 4 days/week, for 5 months.

Interventions/Control_2

Interval walking training + low dose of milk product intake. Subjects consume milk product containing 4.1g milk protein immediately after interval walking training.

Interventions/Control_3

Interval walking training + high dose of milk product intake. Subjects consume milk product containing 12.3g milk protein immediately after interval walking training.

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

50 years-old <=

Age-upper limit

75 years-old >=

Gender

Female

Key inclusion criteria

1) Middle-aged older women who have performed interval walking training more than 6 month.
2) Those whose sustolic/diastolic blood pressures are less than 159/99 mmHg
3) Those who have no difficalty in performing interval walking training
4) Those who attend the study as subjects voluntarily.

Key exclusion criteria

1) Those who have habit of smoking
2) Those whom the chie investigator judged as inappropriate to participate in the study for some reasons.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Nose

Organization

Shinshu University Garduate School of Medicine

Division name

DEpartment of Sports Medical Sciences

Zip code


Address

3-1-1 Asahi Matsumoto 390-8621

TEL

0263-37-2681

Email

nosehir@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Nose

Organization

Shinshu University Graduate School of Medicine

Division name

Department of Sports Medical Sciences

Zip code


Address

3-1-1 Asahi Matsumoto 390-8621

TEL

0263-37-2681

Homepage URL


Email

nosehir@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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



Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 24 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

2012 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 20 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 10 Month 24 Day

Last modified on

2016 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028248


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name