UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047272 |
|---|---|
| Receipt number | R000053910 |
| Scientific Title | Influence of Dietary Nitrate Supplementation on Exercise Performance in Trained and Untrained Male |
| Date of disclosure of the study information | 2022/03/23 |
| Last modified on | 2022/03/23 20:16:33 |
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Basic information
Public title
Influence of Dietary Nitrate Supplementation on Exercise Performance in Trained and Untrained Male
Acronym
Influence of Dietary Nitrate Supplementation on Exercise Performance in Trained and Untrained Male
Scientific Title
Influence of Dietary Nitrate Supplementation on Exercise Performance in Trained and Untrained Male
Scientific Title:Acronym
Influence of Dietary Nitrate Supplementation on Exercise Performance in Trained and Untrained Male
Region
| Asia(except Japan) |
Condition
Condition
Recreationally Active
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess the effects of acute dietary nitrate supplementation, in the form of beetroot crystals (BRC), on exercise tolerance and intermittent performance in trained and untrained population
Basic objectives2
Others
Basic objectives -Others
to assess the effects of acute dietary nitrate supplementation, in the form of beetroot crystals (BRC), on blood glucose and lactate in trained and untrained population
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resting blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial pressure)
Key secondary outcomes
Fractional exhaled hydrogen sulfide
Niric oxide level
Blood glucose and blood lactate
Cognitive function
muscle oxygenation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Medicine |
Interventions/Control_1
capsules containing beetroot crystal
Interventions/Control_2
capsules containing maltodextrin
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Healthy adults
(2) free from injury
(3) Do not have any current or history of cardiovascular, metabolic or pulmonary disease
(4) No contraindication for blood sampling procedure
(5) Pass The Physical Activity Readiness Questionnaire (PAR-Q)
Key exclusion criteria
(1) Smoker
(2) Individual who consume any dietary supplements, quasi drugs or medicines within past 4 weeks
(3) On medication
(4) Receiver of blood transfusion within 1 month prior to screening
(5) Receiver of any investigational research agent prior to 30 days of experimental trial and individual who have a history of or current clinically significant disease
(6) Clinical population or an individual with heart/vascular related problem
(7) Individual with the medical histories of alcoholism or drug dependence
(8) Individual who have contraindication with high intensity exercise
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | MAISARAH |
| Middle name | BINTI MOHD |
| Last name | SALEH |
Organization
UNIVERSITI TEKNOLOGI MARA
Division name
FACULTY OF SPORTS SCIENCE & RECREATION
Zip code
26400
Address
Kampus Jengka Bandar Tun Abdul Razak Jengka Pahang, MALAYSIA
TEL
+60129308441
sarahms@uitm.edu.my
Public contact
Name of contact person
| 1st name | MAISARAH |
| Middle name | |
| Last name | MOHD SALEH |
Organization
UNIVERSITI TEKNOLOGI MARA
Division name
FACULTY OF SPORTS SCIENCE & RECREATION
Zip code
26400
Address
Kampus Jengka Bandar Tun Abdul Razak Jengka Pahang, MALAYSIA
TEL
+60129308441
Homepage URL
sarahms@uitm.edu.my
Sponsor or person
Institute
UNIVERSITI TEKNOLOGI MARA
Institute
Department
Personal name
Funding Source
Organization
UNIVERSITI TEKNOLOGI MARA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
UNIVERSITI TEKNOLOGI MARA
Address
Kampus Jengka Bandar Tun Abdul Razak Jengka Pahang, MALAYSIA
Tel
+60133632005
linoby@uitm.edu.my
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
UNIVERSITI TEKNOLOGI MARA
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053910
