UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of milk-protein and carbohydrate intake during exercise training on cerebral blood flow regulation and dysuria in middle-aged and older people
Title of the study (Brief title)	Effects of milk protein intake during exercise training on health promotion
Region	Japan

Condition
Condition	life-style related disease prevention
Classification by specialty	Hematology and clinical oncology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine whether increased hysical fitness by exercise training improves cerebral blood flow regulation and dysuria and if so, whether milk-protein and carbohydrate intake during training enhance the improvements. In addition, we analyze the relationship between the improved cerebral blood blow regulation and dysuria.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in peak aerobic capacity, cerebral blood flow regulation, and urination function after exercise trainig (intervention) for 2 months
Key secondary outcomes	Changes in carotid arterial compliance,prostate volume,residual urine volume, urination frequency,subjective feeling of urination, and physical chracteristics after exercise training (intervention) for 2 months

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	cycling exercise + milk-protein + carbohydrate intake
Interventions/Control_2	cycling exercise + carbohydrate intake
Interventions/Control_3	no cycling exercise + carbohydrate intake
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	85 years-old >=
Gender	Male
Key inclusion criteria	1) Those who have participated in the Matsumoto Health Promotion Program. 2) Those wo have performed "Interval Walking Training" recommended by the program for more than 6 months 3) Those who are healthy with receiving no treatments for diseases. 4) Those who have received some treatments for some diseases but promise that they will not change the treatments during intervention 5) Those who are interviewed by us and give us a written informed consent to partipate in the study
Key exclusion criteria	1) Those who have showed allergic symptoms aginst milk product intake 2) Those who, we judge, will not be able to perform exercise training with safety 3) Those who have received the operations for prostate and bladder diseases 4) Those who, we judge, are inappropriate for participating in the study for other reasons
Target sample size	45

Research contact person
Name of lead principal investigator	Shizue Masuki
Organization	Shinshu University
Division name	Graduate School of Medicine
Address	3-1-1 Asahi Matsumoto, Nagano
TEL	0263-37-2682
Email	masuki@shinshu-u.ac.jp

Public contact
Name of contact person	Shizue Masuki
Organization	Shinshu University
Division name	Graduate School of Medicine
Address	3-1-1 Asahi Matsumoto, Nagano
TEL	0263-37-2682
Homepage URL
Email	masuki@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	MECSST
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	2018 Year 11 Month 26 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 11 Month 20 Day
Anticipated trial start date	2018 Year 11 Month 26 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	2018 Year 11 Month 22 Day
Last modified on	2018 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039880