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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013309
Receipt No. R000015525
Scientific Title Impact of protein supplement on plasma protein content during exercise training in older people.
Date of disclosure of the study information 2014/03/03
Last modified on 2014/03/02

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Basic information
Public title Impact of protein supplement on plasma protein content during exercise training in older people.
Acronym Exercise training and protein supplement
Scientific Title Impact of protein supplement on plasma protein content during exercise training in older people.
Scientific Title:Acronym Exercise training and protein supplement
Region
Japan

Condition
Condition Heat illness
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of protein supplementation during exercise training on thermal and cardiovascular regulation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Thaermoregulatory and cardiovascylar responses
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Carbohydrate Protein supplement
Interventions/Control_2 Carbohydrate supplement
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
80 years-old >=
Gender Male
Key inclusion criteria 1) Older men who had performed interval walking training more than 6 months.
2) Those whose systolic and diastolic blood pressures were no more than 159mmHg and 99mmHg, respectively.
3) Those who had nodifficulaty in cucling exercise.
4) Those who were willing to participate in the study.
Key exclusion criteria None
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nose
Organization Shinshu University Graduate School of Medicine
Division name Department of Sports Medical Sciences
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0263-37-2681
Email nosehir@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Nose
Organization Shinshu University Graduate School of Medicine
Division name Department of Sports Medical Sciences
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0263-37-2681
Homepage URL
Email nosehir@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Sciety for Promotion of Science
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
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
2014 Year 03 Month 03 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
2011 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 06 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
2014 Year 03 Month 02 Day
Last modified on
2014 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015525

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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