UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001981 |
|---|---|
| Receipt number | R000002418 |
| Scientific Title | Effects of protein supplementation during 5-month fast-walking training on nocturnal and morning blood pressure in middle and elderly people. |
| Date of disclosure of the study information | 2014/07/08 |
| Last modified on | 2019/02/19 21:01:47 |
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Basic information
Public title
Effects of protein supplementation during 5-month fast-walking training on nocturnal and morning blood pressure in middle and elderly people.
Acronym
Protein ingestion and blood pressure
Scientific Title
Effects of protein supplementation during 5-month fast-walking training on nocturnal and morning blood pressure in middle and elderly people.
Scientific Title:Acronym
Protein ingestion and blood pressure
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to examine whether protein supplementation during fast-walking training period reduces nocturnal and morning blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Protein supplementation would enhance a reduction of nocturnal blood pressure and attenuate an increase in blood pressure from night to motning compared with non-protein supplementation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Interval fast-walking trianing
3-4days/week,
total fast-walking time 60min/week,
for 5 months
Interventions/Control_2
protein or placebp supplementation
Interventions/Control_3
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pepole who are no orthopedic and cardiovasucular histories interfered with walking and voluntarily desire to participate in the present study.
Key exclusion criteria
Pepole whose systplic blood pressure is over 150 mmHg or diastolic blood pressure is over 90 mmHg.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Hiroshi Nose |
Organization
Graduate School of Medicine, Shinshu University
Division name
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
0263-37-2682
nosehir@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Yoshi-ichiro Kamijo |
Organization
Graduate School of Medicine, Shinshu University
Division name
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
0263-37-2682
Homepage URL
yoshikmj@shinshu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 07 | Month | 08 | 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
| 2009 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2009 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002418
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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