UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of milk product intake on improvements of QOL and physical fitness in elderly people
Title of the study (Brief title)	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	Hiroshi Nose
Organization	Shinshu University Garduate School of Medicine
Division name	DEpartment of Sports Medical Sciences
Address	3-1-1 Asahi Matsumoto 390-8621
TEL	0263-37-2681
Email	nosehir@shinshu-u.ac.jp

Public contact
Name of contact person	Hiroshi Nose
Organization	Shinshu University Graduate School of Medicine
Division name	Department of Sports Medical Sciences
Address	3-1-1 Asahi Matsumoto 390-8621
TEL	0263-37-2681
Homepage URL
Email	nosehir@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028248