UMIN-CTR Clinical Trial

Basic information
Public title	The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.
Acronym	The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.
Scientific Title	The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.
Scientific Title:Acronym	The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.
Region	Asia(except Japan)

Condition
Condition	supplementation
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	is to investigate the effect of acute dose of beetroot crystals (BRC) on exhaustive high-intensity intermittent exercise using laboratory-based setting.
Basic objectives2	Others
Basic objectives -Others	to determine the effect of blood glucose and lactate following acute dose of beetroot crystals (BRC) consumption.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Fatigue time of high intensity intermittent exercise
Key secondary outcomes	1. Blood pressure level 2. Blood lactate level 3. Blood glucose level

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	Other
Interventions/Control_1	beetroot crystal
Interventions/Control_2	placebo (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	35 years-old >=
Gender	Male
Key inclusion criteria	1. physically healthy 2. normal BMI 3. weight range ; 4. free from injury. 5. male recreational collegiate soccer player (who regularly participate in competitive sport and participate in regular training sessions 6. recreational individual
Key exclusion criteria	1. smokers; 2. consistently on medication over the past 5 weeks; 3. blood transfusion recipient within one month of screening; 4. have history of treatment on leg muscles and/or have musculoskeletal problems, 5. has medical history of drugs or alcoholism and 6. undergoing medical surgery within 6 months of screening 7. has history of cardiovascular, pulmonary, or metabolic disease 8. history of allergy to beetroot
Target sample size	28

Research contact person
Name of lead principal investigator	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
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

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 22 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	28
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	2020 Year 01 Month 08 Day
Date of IRB	2020 Year 04 Month 25 Day
Anticipated trial start date	2022 Year 01 Month 22 Day
Last follow-up date	2022 Year 01 Month 22 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 01 Month 20 Day
Last modified on	2022 Year 01 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053253