UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013309 |
|---|---|
| Receipt number | 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 15:23:21 |
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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
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
nosehir@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015525
