UMIN-CTR Clinical Trial

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
Email	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
Email	sarahms@uitm.edu.my

Sponsor
Institute	UNIVERSITI TEKNOLOGI MARA
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053910