UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004684 |
|---|---|
| Receipt number | R000005576 |
| Scientific Title | Effects of ingesting 5-aminolaevulinic acids (ALA) on cardiovascular, respiratory, and metabolic function during exercise |
| Date of disclosure of the study information | 2010/12/08 |
| Last modified on | 2014/07/08 10:18:39 |
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Basic information
Public title
Effects of ingesting 5-aminolaevulinic acids (ALA) on cardiovascular, respiratory, and metabolic function during exercise
Acronym
Ingestion of ALA and physiological functions during exercise
Scientific Title
Effects of ingesting 5-aminolaevulinic acids (ALA) on cardiovascular, respiratory, and metabolic function during exercise
Scientific Title:Acronym
Ingestion of ALA and physiological functions during exercise
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examin effects of ALA ingestion on physiological functions during exercise in humans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ALA ingestion will suppress an increase in blood lactate concentration, resulting in attenuating enhanced ventilation during graded exercise.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
100g/day of ALA ingestion for 1 week-> placebo
Interventions/Control_2
placebo -> 100g/day of ALA ingestion for 1 wee
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy and non-smoking males whoes participation is voluntary.
Key exclusion criteria
a patient with disease and smoker
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose, MD, PhD |
Organization
Graduate School of Medicine, Shinshu University
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 | 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, 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
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
| 2010 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | 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
| 2010 | Year | 12 | Month | 08 | Day |
Last modified on
| 2014 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005576
