UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of protein supplementation during 5-month fast-walking training on nocturnal and morning blood pressure in middle and elderly people.
Title of the study (Brief title)	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	Dr. Hiroshi Nose
Organization	Graduate School of Medicine, Shinshu University
Division name	Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Address	3-1-1 Asahi, Matsumoto, Japan
TEL	0263-37-2682
Email	nosehir@shinshu-u.ac.jp

Public contact
Name of contact person	Dr. Yoshi-ichiro Kamijo
Organization	Graduate School of Medicine, Shinshu University
Division name	Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Address	3-1-1 Asahi, Matsumoto, Japan
TEL	0263-37-2682
Homepage URL
Email	yoshikmj@shinshu-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Shinshu University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002418