UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046683 |
|---|---|
| Receipt number | 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 17:18:12 |
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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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053253
