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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046683
Receipt No. R000053253
Scientific Title The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.
Date of disclosure of the study information 2022/01/22
Last modified on 2022/01/20

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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