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Protocol summary
A crossover, placebo-controlled, double-blind, randomized, phase 3 clinical trial on 16 judo athletes. The RAND function of Excel software will be used for randomization.
A crossover, placebo-controlled, double-blind, randomized, phase 3 clinical trial on 34 judo athletes. The RAND function of Excel software will be used for randomization.
A crossover, placebo-controlled, double-blind, randomized, phase 3 clinical trial on 1634 judo athletes. The RAND function of Excel software will be used for randomization.
کارآزمایی بالینی متقاطع، کنترل شده با دارونما، دو سویه کور ، تصادفی شده، فاز 3 بر روی 16 جودوکار. برای تصادفی سازی از فانکشن RAND نرم افزار اکسل استفاده خواهد شد.
کارآزمایی بالینی متقاطع، کنترل شده با دارونما، دو سویه کور ، تصادفی شده، فاز 3 بر روی 34 جودوکار. برای تصادفی سازی از فانکشن RAND نرم افزار اکسل استفاده خواهد شد.
کارآزمایی بالینی متقاطع، کنترل شده با دارونما، دو سویه کور ، تصادفی شده، فاز 3 بر روی 1634 جودوکار. برای تصادفی سازی از فانکشن RAND نرم افزار اکسل استفاده خواهد شد.
Participants will perform two sessions of SJFT after beetroot or placebo supplementation. The number of throws (TT), heart rate (HR) immediately at the end of SJFT (HR0) and 1 minute after SJFT (HR1), SJFT index and rate of perceived exertion (RPE) will be measured. This study will use a double-blind method (participants and researchers). The study will take place in Ankara, Turkey.
Participants will perform two sessions of SJFT after beetroot or placebo supplementation. The number of throws (TT), heart rate (HR) immediately at the end of SJFT (HR0) and 1 minute after SJFT (HR1), SJFT index, rate of perceived exertion (RPE), muscle oxygenation, and plasma nitrate, nitrite and lactate levels will be measured. This study will use a double-blind method (participants and researchers). The study will take place in Ankara, Turkey.
Participants will perform two sessions of SJFT after beetroot or placebo supplementation. The number of throws (TT), heart rate (HR) immediately at the end of SJFT (HR0) and 1 minute after SJFT (HR1), SJFT index and, rate of perceived exertion (RPE), muscle oxygenation, and plasma nitrate, nitrite and lactate levels will be measured. This study will use a double-blind method (participants and researchers). The study will take place in Ankara, Turkey.
شرکتکنندگان دو جلسه SJFT را پس از مصرف مکمل چغندر یا دارونما انجام خواهند داد. تعداد پرتابها (TT)، ضربان قلب (HR) بلافاصله در پایان SJFT (HR0) و 1 دقیقه پس از SJFT (HR1)، شاخص SJFT و میزان درک فشار (RPE) اندازهگیری خواهد شد. این مطالعه از روش دوسوکور (شرکتکنندگان و محققان) استفاده خواهد کرد. این مطالعه در آنکارا، ترکیه انجام خواهد شد.
شرکتکنندگان دو جلسه SJFT را پس از مصرف مکمل چغندر یا دارونما انجام خواهند داد. تعداد پرتابها (TT)، ضربان قلب (HR) بلافاصله در پایان SJFT (HR0) و 1 دقیقه پس از SJFT (HR1)، شاخص SJFT، میزان درک فشار (RPE)، اکسیژن رسانی عضلانی، و مقدار نیترات، نیتریت و لاکتات پلاسمایی اندازهگیری خواهد شد. این مطالعه از روش دوسوکور (شرکتکنندگان و محققان) استفاده خواهد کرد. این مطالعه در آنکارا، ترکیه انجام خواهد شد.
شرکتکنندگان دو جلسه SJFT را پس از مصرف مکمل چغندر یا دارونما انجام خواهند داد. تعداد پرتابها (TT)، ضربان قلب (HR) بلافاصله در پایان SJFT (HR0) و 1 دقیقه پس از SJFT (HR1)، شاخص SJFT و، میزان درک فشار (RPE)، اکسیژن رسانی عضلانی، و مقدار نیترات، نیتریت و لاکتات پلاسمایی اندازهگیری خواهد شد. این مطالعه از روش دوسوکور (شرکتکنندگان و محققان) استفاده خواهد کرد. این مطالعه در آنکارا، ترکیه انجام خواهد شد.
Consuming beetroot juice supplement (140 ml) or placebo (140 ml of water with red food coloring) 120 minutes before exercise sessions
Consuming beetroot juice supplement (140 ml) or placebo (140 ml of nitrate-depleted beetroot juice) 120 minutes before exercise sessions
Consuming beetroot juice supplement (140 ml) or placebo (140 ml of water with red food coloringnitrate-depleted beetroot juice) 120 minutes before exercise sessions
مصرف مکمل آب چغندر (140 میلی لیتر) یا دارونما (140 میلی لیتر آب با رنگ خوراکی قرمز) 120 دقیقه قبل از جلسات ورزشی
مصرف مکمل آب چغندر (140 میلی لیتر) یا دارونما (140 میلی لیتر آب چغندر فاقد نیترات) 120 دقیقه قبل از جلسات ورزشی
مصرف مکمل آب چغندر (140 میلی لیتر) یا دارونما (140 میلی لیتر آب با رنگ خوراکی قرمزچغندر فاقد نیترات) 120 دقیقه قبل از جلسات ورزشی
General information
16
34
1634
empty
Adding some secondary variables to evaluate possible mechanisms; Adding subjects number to enhance statistical analysis power; Using nitrate-depleted beetroot juice as a placebo to enhancing blinding effect.
Adding some secondary variables to evaluate possible mechanisms; Adding subjects number to enhance statistical analysis power; Using nitrate-depleted beetroot juice as a placebo to enhancing blinding effect.
empty
افزودن برخی متغیرهای ثانویه برای اندازه گیری سازوکارهای احتمالی؛ اضافه کردن تعداد آزمودنی ها برای افزایش توان تحلیل های آماری؛ استفاده از مکمل آب چغندر فاقد نیترات بعنوان دارونما برای افزایش اثر کورسازی.
افزودن برخی متغیرهای ثانویه برای اندازه گیری سازوکارهای احتمالی؛ اضافه کردن تعداد آزمودنی ها برای افزایش توان تحلیل های آماری؛ استفاده از مکمل آب چغندر فاقد نیترات بعنوان دارونما برای افزایش اثر کورسازی.
Secondary outcomes
#1
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Plasma nitrate concentration
Plasma nitrate concentration
empty
غلظت نیترات پلاسمایی
غلظت نیترات پلاسمایی
empty
At baseline, pre-test, and post-test (5 minutes after exercise)
At baseline, pre-test, and post-test (5 minutes after exercise)
empty
در حالت پایه، پیش آزمون و پس آزمون (5 دقیقه بعد از ورزش)
در حالت پایه، پیش آزمون و پس آزمون (5 دقیقه بعد از ورزش)
empty
By high‑performance liquid chromatography method (ENO‑20; EiCom, Kyoto, Japan)
By high‑performance liquid chromatography method (ENO‑20; EiCom, Kyoto, Japan)
empty
با روش کروماتوگرافی مایع عملکرد بالا (ENO‑20; EiCom، کیوتو، ژاپن)
با روش کروماتوگرافی مایع عملکرد بالا (ENO‑20; EiCom، کیوتو، ژاپن)
#2
empty
Plasma nitrite concentration
Plasma nitrite concentration
empty
غلظت نیتریت پلاسمایی
غلظت نیتریت پلاسمایی
empty
At baseline, pre-test, and post-test (5 minutes after exercise)
At baseline, pre-test, and post-test (5 minutes after exercise)
empty
در حالت پایه، پیش آزمون و پس آزمون (5 دقیقه بعد از ورزش)
در حالت پایه، پیش آزمون و پس آزمون (5 دقیقه بعد از ورزش)
empty
By high‑performance liquid chromatography method (ENO‑20; EiCom, Kyoto, Japan)
By high‑performance liquid chromatography method (ENO‑20; EiCom, Kyoto, Japan)
empty
با روش کروماتوگرافی مایع عملکرد بالا (ENO‑20; EiCom، کیوتو، ژاپن)
با روش کروماتوگرافی مایع عملکرد بالا (ENO‑20; EiCom، کیوتو، ژاپن)
#3
empty
Plasmalactate
Plasmalactate
empty
لاکتات پلاسمایی
لاکتات پلاسمایی
empty
At baseline, pre-test, and post-test (5 minutes after exercise)
At baseline, pre-test, and post-test (5 minutes after exercise)
empty
در حالت پایه، پیش آزمون و پس آزمون (5 دقیقه بعد از ورزش)
در حالت پایه، پیش آزمون و پس آزمون (5 دقیقه بعد از ورزش)
empty
Using a lactate ELISA kit
Using a lactate ELISA kit
empty
با استفاده از کیت الایزای لاکتات
با استفاده از کیت الایزای لاکتات
#4
empty
Muscle oxygenation
Muscle oxygenation
empty
اکسیژن رسانی عضلانی
اکسیژن رسانی عضلانی
empty
During the SJFT
During the SJFT
empty
در طول SJFT
در طول SJFT
empty
Near-infrared spectroscopy
Near-infrared spectroscopy
empty
طیف سنجی اشعه مادون قرمز-نزدیک
طیف سنجی اشعه مادون قرمز-نزدیک
Intervention groups
#1
Placebo (140 ml) will be consumed 2 hours before exercise in opaque bottles. Placebo will be prepared by adding flavor and red food color (McCormick red food color; FD&C reds 40 and 3) to water.
Placebo (140 ml) will be consumed 2 hours before exercise in opaque bottles. Commercial nitrate-depleted beetroot juice supplement (NO₃⁻-depleted BJ, Beet It Sport®, James White Drinks Ltd., UK) will be used in this study.
Placebo (140 ml) will be consumed 2 hours before exercise in opaque bottles. PlaceboCommercial nitrate-depleted beetroot juice supplement (NO₃⁻-depleted BJ, Beet It Sport®, James White Drinks Ltd., UK) will be prepared by adding flavor and red food color (McCormick red food color; FD&C reds 40 and 3) to waterused in this study.
گروه کنترل: دارونما (140 میلی لیتر) 2 ساعت قبل از ورزش در بطری های مات 2 ساعت قبل از ورزش مصرف خواهد شد. دارونما از طریق اضافه کردن طعم دهنده و رنگ خوراکی قرمز (McCormick red food color; FD&C reds 40 and 3) به آب تهیه خواهد شد.
گروه کنترل: دارونما (140 میلی لیتر) 2 ساعت قبل از ورزش در بطری های مات 2 ساعت قبل از ورزش مصرف خواهد شد. از مکمل آب چغندر فاقد نیترات تجاری (NO₃⁻-depleted BJ, Beet It Sport®, James White Drinks Ltd., UK) در این مطالعه استفاده خواهد شد.
گروه کنترل: دارونما (140 میلی لیتر) 2 ساعت قبل از ورزش در بطری های مات 2 ساعت قبل از ورزش مصرف خواهد شد. دارونما از طریق اضافه کردن طعم دهنده و رنگ خوراکی قرمز (McCormick red food color; FD&C reds 40 and 3) بهمکمل آب تهیهچغندر فاقد نیترات تجاری (NO₃⁻-depleted BJ, Beet It Sport®, James White Drinks Ltd., UK) در این مطالعه استفاده خواهد شد.
Protocol summary
Study aim
This study aims to evaluate the effect of training status on the Special Judo Fitness Test (SJFT) performance following beetroot juice ingestion.
Design
A crossover, placebo-controlled, double-blind, randomized, phase 3 clinical trial on 34 judo athletes. The RAND function of Excel software will be used for randomization.
Settings and conduct
Participants will perform two sessions of SJFT after beetroot or placebo supplementation. The number of throws (TT), heart rate (HR) immediately at the end of SJFT (HR0) and 1 minute after SJFT (HR1), SJFT index, rate of perceived exertion (RPE), muscle oxygenation, and plasma nitrate, nitrite and lactate levels will be measured. This study will use a double-blind method (participants and researchers). The study will take place in Ankara, Turkey.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having at least a Purple Belt in Judo
Free from neuromuscular and musculoskeletal disorders
Non-smokers
Non-alcoholic
Not consumers of medicine
Exclusion criteria:
Having any injuries or pain
Inability to perform tests
Non-adherence to recommendations
Intervention groups
Consuming beetroot juice supplement (140 ml) or placebo (140 ml of nitrate-depleted beetroot juice) 120 minutes before exercise sessions
Main outcome variables
Number of throws; Heart rate immediately after SJFT; Heart rate one minute after SJFT; SJFT index; Rate of perceived exertion
General information
Reason for update
Adding some secondary variables to evaluate possible mechanisms; Adding subjects number to enhance statistical analysis power; Using nitrate-depleted beetroot juice as a placebo to enhancing blinding effect.
Acronym
IRCT registration information
IRCT registration number:IRCT20231004059615N3
Registration date:2025-05-22, 1404/03/01
Registration timing:registered_while_recruiting
Last update:2026-04-07, 1405/01/18
Update count:1
Registration date
2025-05-22, 1404/03/01
Registrant information
Name
Davar Khodadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 3583
Email address
davar.khodadadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2025-05-31, 1404/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acute effects of beetroot juice supplementation on the Special Judo Fitness Test performance in judokas: a randomized double-blinded crossover trial
Public title
Acute effects of beetroot juice supplementation on judo performance
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least a Purple Belt in Judo
Free from neuromuscular and musculoskeletal disorders
Non-smokers
Non-alcoholic
Not consumers of medicine
Exclusion criteria:
Having any injuries or pain
Inability to perform tests
Age
From 20 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
The names of the subjects will be entered in one column of Excel; in another column, a number will be randomly assigned to each subject using the RAND function (=RAND()); then, the numbers will be sorted from smallest to largest; 50% of the subjects (from rows 1 to 8) will receive the supplement and the other 50% (from rows 9 to 16) will receive the placebo. In the second experimental session, the subjects will be switched (subjects who received the supplement in the first session will receive the placebo in the second session and vice versa).
Blinding (investigator's opinion)
Double blinded
Blinding description
The order of beetroot juice supplement or placebo intake will be determined randomly by a person outside the study, and participants and researchers will not be informed of it until after data analysis. Also, subjects will receive the supplement and placebo in an opaque container with a similar appearance. In addition, the color and taste of the placebo will be similar to the beetroot juice through the addition of food coloring and flavoring.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the International Science and Technology University
Street address
Tunahan Mah. Dumlupinar 30 Agustos Cad. No:2, Metromal Business F Blok Office
City
Ankara
Postal code
21,06824
Approval date
2025-05-14, 1404/02/24
Ethics committee reference number
202505-03
Health conditions studied
1
Description of health condition studied
Improve exercise performance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
SJFT index
Timepoint
َAfter SJFT
Method of measurement
Using the following formula: SJFT index = HR0 + HR1 / total number of throws
Secondary outcomes
1
Description
Rate of perceived exertion
Timepoint
Following SJFT
Method of measurement
Using the Borg scale
2
Description
Number of throws
Timepoint
During the SJFT
Method of measurement
Counting the number
3
Description
Heart rate
Timepoint
Immediately at the end of SJFT and 1 minute after SJFT
Method of measurement
Using a Polar heart rate monitor
4
Description
Plasma nitrate concentration
Timepoint
At baseline, pre-test, and post-test (5 minutes after exercise)
Method of measurement
By high‑performance liquid chromatography method (ENO‑20; EiCom, Kyoto, Japan)
5
Description
Plasma nitrite concentration
Timepoint
At baseline, pre-test, and post-test (5 minutes after exercise)
Method of measurement
By high‑performance liquid chromatography method (ENO‑20; EiCom, Kyoto, Japan)
6
Description
Plasmalactate
Timepoint
At baseline, pre-test, and post-test (5 minutes after exercise)
Method of measurement
Using a lactate ELISA kit
7
Description
Muscle oxygenation
Timepoint
During the SJFT
Method of measurement
Near-infrared spectroscopy
Intervention groups
1
Description
Intervention group: Beetroot juice supplement (140 ml, containing approximately 12.8 mmol nitrate) in opaque bottles will be consumed 2 hours before exercise. Commercial beetroot juice supplement (BEET It Sport®; James White Drinks Ltd., Ipswich, UK) will be used in this study.
Category
Rehabilitation
2
Description
Placebo (140 ml) will be consumed 2 hours before exercise in opaque bottles. Commercial nitrate-depleted beetroot juice supplement (NO₃⁻-depleted BJ, Beet It Sport®, James White Drinks Ltd., UK) will be used in this study.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
INTERNATIONAL SCIENCE AND TECHNOLOGY UNIVERSITY
Full name of responsible person
Heidar Sajedi
Street address
Tunahan Mah. Dumlupinar 30 Agustos Cad. No:2, Metromal Business F Blok Office
City
Ankara
Postal code
21,06824
Phone
+90 312 475 76 15
Email
heidar.sajedi@istu.edu.pl
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
INTERNATIONAL SCIENCE AND TECHNOLOGY UNIVERSITY
Full name of responsible person
Erdal Dursun
Street address
Tunahan Mah., Dumlupinar 30 Agustos Cad. No. 2, Metromal Business F Blok Office
City
Ankara
Postal code
21,06824
Phone
+90 312 475 76 15
Email
heidar.sajedi@istu.edu.pl
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
INTERNATIONAL SCIENCE AND TECHNOLOGY UNIVERSITY
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
Ir
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Davar Khodadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sports Sciences, Velayat University Complex, Shahid Sohani St., Sohank
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 2263 3583
Fax
Email
davar.khodadadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Davar Khodadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sports Sciences, Velayat University Complex, Shahid Sohani St., Sohank
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 2263 3583
Fax
Email
davar.khodadadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Davar Khodadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sports Sciences, Velayat University Complex, Shahid Sohani St., Sohank
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 2263 3583
Fax
Email
davar.khodadadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data collected during the study will be shareable after de-identifying the subjects.
When the data will become available and for how long
The data will be published after the extracted articles are accepted.
To whom data/document is available
All people
Under which criteria data/document could be used
All data collected during the study will be shareable after de-identifying the subjects. The requester will only be permitted to use the data for meta-analysis reviews.
From where data/document is obtainable
Corresponding author:
Davar Khodadadi, Faculty of Physical Education and Sports Sciences, Islamic Azad University Central Tehran Branch, Tehran, Iran
Email: davar.khodadadi@yahoo.com
What processes are involved for a request to access data/document
Sending an email request to the corresponding author:
Davar Khodadadi
Email: davar.khodadadi@yahoo.com