UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005948 |
|---|---|
| Receipt number | R000007027 |
| Scientific Title | Mechanisms of an increase in plasma protein induced by exercise training and effects of protein supplementation on the mechanisms in elderly people |
| Date of disclosure of the study information | 2014/07/08 |
| Last modified on | 2019/02/19 21:09:42 |
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Basic information
Public title
Mechanisms of an increase in plasma protein induced by exercise training and effects of protein supplementation on the mechanisms in elderly people
Acronym
Protein supplementation after exercise to prevent elderly from heat stroke
Scientific Title
Mechanisms of an increase in plasma protein induced by exercise training and effects of protein supplementation on the mechanisms in elderly people
Scientific Title:Acronym
Protein supplementation after exercise to prevent elderly from heat stroke
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate effects of carbohydrate and protein suplementation after exercise training for 2 months on thermoregulatory and blood pressure controls in the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
thermoregulatory responses
blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
protein and carbohydrate suplementation group
(15g catbohydrate and 10g protein)
8 months; ; 60-70%VO2peak, 4days/week
Interventions/Control_2
placebo group
8 months; ; 60-70%VO2peak, 4days/week
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
Male and female subjects who desire to participate by voluntary agreement
Key exclusion criteria
Systolic and diastolic blood pressures over 160 mmHg and 100 mmHg
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose, MD, PhD |
Organization
Shinshu University, Graduate School of Medicine
Division name
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2681
nosehir@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshi-ichiro Kamijo, MD, PhD |
Organization
Shinshu University, Graduate School of Medicine
Division name
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
Homepage URL
yoshikmj@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention,
Shinshu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
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
Published
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
| 2011 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 04 | 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
| 2011 | Year | 07 | Month | 07 | 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=R000007027
