UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023975 |
|---|---|
| Receipt number | R000027540 |
| Scientific Title | Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method |
| Date of disclosure of the study information | 2016/09/12 |
| Last modified on | 2017/09/05 14:18:44 |
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Basic information
Public title
Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method
Acronym
Effect of Non-essential Amino Acids on Protein Requirements
Scientific Title
Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method
Scientific Title:Acronym
Effect of Non-essential Amino Acids on Protein Requirements
Region
| North America |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the current study is to investigate the importance of Non Essential Amino Acids for endurance-trained male subjects
Basic objectives2
Others
Basic objectives -Others
The objective of the current study is to investigate the importance of Non Essential Amino Acids for endurance-trained male subjects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
13CO2 (carbon dioxide) excretion rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
BASE egg protein
0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein
Interventions/Control_2
BCAA-enriched egg protein
BCAA-enriched egg protein provided as crystalline amino acid.
Interventions/Control_3
small amount of essential amino acids
essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of essential amino acid in BASE egg protein
Interventions/Control_4
large amount of essential amino acids
essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of amino acid in BCAA-enriched egg protein
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
-endurance-trained participants who regularly run more than 40 km/week.
-Ability to complete the 16-km familiarization run.
Key exclusion criteria
-Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
-Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
-Regular tobacco use
-Illicit drug use
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daniel Moore |
Organization
University of Toronto
Division name
Faculty of kinesiology and physical education
Zip code
Address
100 Devonshire Place, Toronto, Ontario
TEL
+1-416-946-4088
dr.moore@utoronto.ca
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki KATO |
Organization
University of Toronto
Division name
Faculty of Kinesiology and physical education
Zip code
Address
100 Devonshire Place, Toronto, Ontario
TEL
+1-416-946-5620
Homepage URL
h.kato@utoronto.ca
Sponsor or person
Institute
University of Toronto
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto co. Inc.
Organization
Division
Category of Funding Organization
Profit 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
YES
Study ID_1
NCT02874638
Org. issuing International ID_1
clinicaltrial.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 12 | 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
| 2016 | Year | 09 | Month | 08 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027540
