aim of this study is to investigate the acute effect of acute consumption of a compound supplement containing inorganic nitrate from red beetroot extract along with vitamin C on maximum and average power during short-term exercise with maximum intensity and factors related to fatigue in semi-professional athletes.
Design
crossover clinical trial; Double-blind, randomized, placebo-controlled study on 28 semi-professional male wrestlers, 18-35 years old, randomized using permuted block randomization with blocks of four using an online site (www. .sealedenvelope.com)
Settings and conduct
Blinding of the participants and the researcher, performed in the Faculty of Sports Sciences of Ferdowsi University of Mashhad, performing the Wingate anaerobic test using the Monarch ergometer bicycle by 28 wrestlers of the Mashhad wrestling team.
Participants/Inclusion and exclusion criteria
1- Age 18-35 years
2- semi-professional wrestler men; More than two years of experience in sports activities with a high glycolytic energy metabolism component
3- Willingness to participate in research
Intervention groups
Drug receiving group: 14 male semi-professional wrestlers will receive 1 sports drink each.
Placebo group: 14 semi-professional wrestlers will each receive 1 placebo sports drink, which is completely similar in appearance and volume to the combined beetroot and vitamin C sports drink.
3 hours after consuming the drinks, the samples will each perform a Wingate performance test.
After the two-week washout period, the place of each participant in the groups will be changed, and all people will take the Wingate test once after taking the combined supplement and once after taking the placebo.
Main outcome variables
Serum level of lactate dehydrogenase, creatine kinase, blood sugar
Wingate functional test data:
• Anaerobic peak power
• Anaerobic mean power
• Fatigue index
• Time to peak power
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240407061440N1
Registration date:2024-06-07, 1403/03/18
Registration timing:registered_while_recruiting
Last update:2024-06-07, 1403/03/18
Update count:0
Registration date
2024-06-07, 1403/03/18
Registrant information
Name
Maede Nojoumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3223 3662
Email address
m.nojoumi78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of acute vitamin C-enriched beetroot supplementation on the 30-second high-intensity inertial cycle ergometer test: a crossover, double-blind, placebo-controlled clinical trial
Public title
Investigating the effect of supplementation with vitamin C-enriched red beetroot extract on an anaerobic test
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-35 years
semi-professional wrestler men; More than two years of experience in sports activities with a high glycolytic energy metabolism component (such as speed tests in swimming, martial arts and team sports) that is not considered an elite athlete.
Willingness to participate in research
Exclusion criteria:
The occurrence of any incident that affects a person's health.
Having any acute illness during the study
Unwillingness to continue cooperation in research
The occurrence of complications that lead to disruption in the quality of life and exercise of the participants.
Age
From 18 years old to 35 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
28
More than 1 sample in each individual
Number of samples in each individual:
2
Because it is a cross-over study, Wingate functional test will be taken from each person twice, and blood will be taken before and after.
Randomization (investigator's opinion)
Randomized
Randomization description
To apply randomization, the random block method (permuted block randomization) with blocks of four will be used. According to the sample size of 28 that has been determined, the blocks will be produced using the online site (www.sealedenvelope.com). In order to apply concealment in the randomization process, unique codes will be used on medicine boxes, and the desired code will be generated by the online site.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in this study are blinded, so that 28 semi-professional wrestlers each received a supplement and after a 2-week washout period, a placebo, which in terms of appearance and volume is completely similar to a combined beetroot and vitamin C sports drink. will do Without knowing what the content of the received drink was every time.
The people who evaluate the data and results in this study and the statistical consultant are also blinded in this study.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences
Street address
Nutrition Department, School of Medicine, East door of Ferdowsi University, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2024-04-06, 1403/01/18
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1403.011
Health conditions studied
1
Description of health condition studied
Healthy wrestlers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
• Anaerobic peak power
Timepoint
3 hours after consuming a sports drink or placebo and when performing the Wingate test
Method of measurement
Applying the Wingate test to the Monark bicycle
Secondary outcomes
1
Description
Anaerobic mean power
Timepoint
3 hours after consuming a sports drink or placebo and when applying the Wingate test
Method of measurement
Applying Wingate's anaerobic test to Monark bicycle
2
Description
Lactate dehydrogenase (LDH)
Timepoint
3 hours after consuming the drink, that is, before starting the warm-up exercises and immediately after the Wingate test And 24 hours later
Method of measurement
LDH Assay Kit
3
Description
Creatine phosphokinase
Timepoint
3 hours after consuming the drink, i.e. right before starting the warm-up exercises and immediately after the Wingate test And 24 hours later
Method of measurement
Human Creatine Phosphokinase (CPK) elisa-kit
4
Description
blood sugar
Timepoint
3 hours after consuming the drink, i.e. right before starting the warm-up exercises and immediately after the Wingate test
Method of measurement
Glucose determination kit
Intervention groups
1
Description
The complementary group of 14 semi-professional wrestlers will each receive 1 sports drink that is a combination of red beetroot and vitamin C (8.4 mmol nitrate + 90 mg vitamin C). 3 hours later, blood sampling is done from people and Wingate functional test is performed immediately. And blood sampling is done immediately after the end of the Wingate test and 24 hours later.
Category
Other
2
Description
Intervention group: the supplementary group of 14 semi-professional wrestlers will each receive 1 drink. 3 hours later, blood will be drawn from the subjects and they will immediately perform the Wingate functional test. And blood sampling is done immediately after the end of the Wingate test and 24 hours later.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad wrestling clubs
Full name of responsible person
Maede Nojoumi
Street address
Mashhad University of Medical Sciences, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 911 515 4350
Email
m.nojoumi78@gmail.com
Web page address
https://www.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mubarhan
Street address
Azadi square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3800 2420
Email
GhayourM@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Mashhad University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maede Nojoumi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Medical School, Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2418
Email
m.nojoumi78@gmail.com
Web page address
https://www.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Azadi Square, Campus of University, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2418
Email
reza.rezvani.rr@gmail.com
Web page address
https://www.mums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maede Nojoumi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Azadi square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
m.nojoumi78@gmail.com
Web page address
https://www.mums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Non-identifiable personal information of study participants will be shared. Also, the results and statistical analysis of the research will be published in the relevant articles.
When the data will become available and for how long
Data access will start 6 months after the results are published.
To whom data/document is available
Participants' de-identified personal information will then be shared with other researchers at academic institutions.
Under which criteria data/document could be used
Participants' non-identifiable personal information may only be used for research aspects.
From where data/document is obtainable
The non-identifiable information of the participants can be obtained by sending an email to Dr. Reza Rezvani (reza.rezvani.rr@gmail.com).
What processes are involved for a request to access data/document
Other researchers in academic institutions can submit their request via email to Dr. Reza Rezvani. The data will be sent to them after consultation and approval of the research team.