UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034977
Receipt number 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 17:09:51

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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 or person

Institute

Shinshu University

Institute

Department

Personal name



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

Value
https://center6.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