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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034977
Receipt No. R000039880
Scientific Title Effects of milk-protein and carbohydrate intake during exercise training on cerebral blood flow regulation and dysuria in middle-aged and older people
Date of disclosure of the study information 2018/11/26
Last modified on 2018/11/22

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Basic information
Public title Effects of milk-protein and carbohydrate intake during exercise training on cerebral blood flow regulation and dysuria in middle-aged and older people
Acronym Effects of milk protein intake during exercise training on health promotion
Scientific Title Effects of milk-protein and carbohydrate intake during exercise training on cerebral blood flow regulation and dysuria in middle-aged and older people
Scientific Title:Acronym 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
1st name
Middle name
Last name Shizue Masuki
Organization Shinshu University
Division name Graduate School of Medicine
Zip code
Address 3-1-1 Asahi Matsumoto, Nagano
TEL 0263-37-2682
Email masuki@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shizue Masuki
Organization Shinshu University
Division name Graduate School of Medicine
Zip code
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)

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
2018 Year 11 Month 26 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 Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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