Protocol summary

Summary
18 taekwondo athletes will participate in this double-blind randomized clinical trial with crossover design. Before intervention every person's background information will be recorded, including age, height, weight, BMI and dominant leg. The information related to the intended exercise tests (isokinetic and balance tests), blood pressure and heart rate will be also collected before and after intervention. Subjects will be randomly allocated into two groups of nine supplement and placebo. In phase I of the study, intervention group will receive concentrated nitrate-rich beetroot juice (2x 70 ml/day of concentrated beetroot juice with 8 mmol nitrate content) and placebo group will receive black currant juice (2x 70 ml/day of black currant juice with negligible nitrate content) for six days. After a 10-day washout period, phase II of the study will be initiated and then intervention and placebo groups will be interchanged. The measurement of isokinetic parameters and balance test will be conducted on day 6 of the study. isokinetic parameters such as peak torque, peak power and total work during knee extension for both legs will be measured using the Biodex isokinetic dynamometer system at angular velocities of 60, 90, 180, 270 and 360 °/s. subsequently, the subjects performed a 50 contraction fatigue test at angular velocity of 180°/s. The balance will be assessed using athlete single leg protocol on the the Biodex balance system. Then the effect of concentrated nitrate-rich beetroot juice on the isokinetic parameters and balance will be determined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072735331N1
Registration date: 2017-11-18, 1396/08/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-18, 1396/08/27
Registrant information
Name
samaneh khosravi
Name of organization / entity
Tehran University of Medical Sciences(School of Nutritional Sciences and Dietetics)
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
skhosravi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2017-11-10, 1396/08/19
Expected recruitment end date
2017-12-14, 1396/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of concentrated nitrate-rich beetroot juice on some of lower extremity isokinetic parameters and balance in taekwondo athletes
Public title
The effect of concentrated beetroot juice on muscle strength and balance in taekwondo athletes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: -the tendency to cooperation -18 to 32 years old taekwondo athletes - having necessary readiness for performing exercise tests using the Physical Activity Readiness Questionnaire Exclusion criteria: -will be unable to continue cooperation -the emergence of lower extremity injuries -making a change in the diet (or consumption of nitrate- rich foods) using the 24-hour Dietary Recall method -the consumption of any kind of supplements during the study -not consuming of concentrated nitrate-rich beetroot juice (in the two cases: 1-more than once during the study 2- on day 6 of the study) -will be unable to execute the knee extensor test using proper form
Age
From 18 years old to 32 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, on the corner of Qods street, Keshavarz Boulevard
City
Tehran
Postal code
1417653761
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.TUMS.VCR.REC.1395.186

Health conditions studied

1

Description of health condition studied
healthy athletes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
peak torque
Timepoint
before and after intervention
Method of measurement
Biodex isokinetic dynamometer system

2

Description
peak power
Timepoint
before and after intervention
Method of measurement
Biodex isokinetic dynamometer system

3

Description
Total work
Timepoint
before and after intervention
Method of measurement
Biodex isokinetic dynamometer system

4

Description
stability index
Timepoint
before and after intervention
Method of measurement
Biodex balance system

Secondary outcomes

1

Description
Heart rate
Timepoint
before and after intervention
Method of measurement
Heart rate monitor

2

Description
Systolic and Diastolic blood pressure
Timepoint
before and after intervention
Method of measurement
Blood pressure device

3

Description
MAP
Timepoint
before and after intervention
Method of measurement
calculating

Intervention groups

1

Description
Intervention group: concentrated nitrate-rich beetroot juice, 2 x 70 ml (140 ml) , twice a day( one in the morning, one in the evening) for 6 days
Category
Placebo

2

Description
Placebo group: black currant juice, 2 x 70 ml (140 ml), twice a day (one in the morning, one in the evening) for 6 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti University
Full name of responsible person
Sajjad Ahmadizad
Street address
School of Physical Education and Sport Sciences, Shahid Beheshti University, Daneshjou Boulevard, Evin, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
International Campus, Tehran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research of International Campus
Street address
#124, Baradaran Mozaffar street, Dameshq street, south Felestin street, Keshavarz Boulevard, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Campus, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Khosravi
Position
Master's Student of nutritional sciences
Other areas of specialty/work
Street address
#44 Hojjatdust St., Naderi St, Keshavarz Boulevard, School of Nutritional Sciences and Dietetics, Tehran
City
Tehran
Postal code
6439311416
Phone
+98 21 8895 5975
Fax
+98 21 8895 5975
Email
s.khosravi86@ymail.comskhosravi@razi.tums.ac.ir
Web page address
http://snsd.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kurosh Djafarian
Position
associated professor/ PhD
Other areas of specialty/work
Street address
#44 Hojjatdust St., Naderi St, Keshavarz Boulevard, School of Nutritional Sciences and Dietetics, Tehran
City
Tehran
Postal code
6439311416
Phone
+98 21 8895 5569
Fax
+98 21 8895 5975
Email
kdjafarian@tums.ac.ir
Web page address
http://snsd.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Khosravi
Position
Master's Student of Nutritional Sciences
Other areas of specialty/work
Street address
#44 Hojjatdust St., Naderi St, Keshavarz Boulevard, School of Nutritional Sciences and Dietetics
City
Tehran
Postal code
6439311416
Phone
+98 21 8895 5975
Fax
+98 21 8895 5975
Email
s.khosravi86@ymail.comskhosravi@razi.tums.ac.ir
Web page address
http://snsd.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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