Protocol summary

Study aim
The effect of beetroot juice supplementation on blood nitrate levels, sport performance, and cognitive function in adult soccer players
Design
A controlled, double-blind, randomized, phase 2 clinical trial with crossover groups on 20 athletes. In this crossover study, subjects were distributed between two intervention and placebo groups in phase 1, and after a one-week washout period, subjects were switched between the two groups. For randomization in this study, a lottery method was used as a simple randomization method.
Settings and conduct
This study will be done in a covered sports hall. First, participants will be asked to go to the hall after 12 hours of fasting. Five mL blood samples will be collected from each participant. Moreover, demographic information and data on clinical history, physical activity, and a 24-h dietary recall will be gathered. After blood sampling, participants will consume a standard breakfast. Thirty min after breakfast, participants will receive either 140 mL beetroot juice (BRJ) containing 800 mg nitrate (2*70 mL) or natural BRJ without added nitrate. 150 min after BRJ intake, blood sampling will be repeated. After that, sport performance tests will be performed. All participants and outcome assessors will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria • Football athletes aged 18 to 22 years Exclusion criteria • Sensitivity to nitrate-rich beetroot juice and its compounds
Intervention groups
10 female athletes and 10 male athletes each receive 140 ml of nitrate-rich beetroot juice or normal beetroot juice during exercise sessions (totally 2 sessions for each group). . They will receive the supplement and in the next session they will change places.
Main outcome variables
Aerobic capacity, maximum vertical jump, 30 m speed, cognitive function, blood nitrate level.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240521061856N1
Registration date: 2024-12-28, 1403/10/08
Registration timing: retrospective

Last update: 2024-12-28, 1403/10/08
Update count: 0
Registration date
2024-12-28, 1403/10/08
Registrant information
Name
Omid Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3174
Email address
omidsadeghi2012@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-23, 1403/04/03
Expected recruitment end date
2025-02-28, 1403/12/10
Actual recruitment start date
2024-06-23, 1403/04/03
Actual recruitment end date
2024-09-28, 1403/07/07
Trial completion date
2024-11-15, 1403/08/25
Scientific title
The effect of beetroot juice supplementation on blood nitrate levels, sport performance, and cognitive function in adult soccer players: a double-blinded crossover randomized controlled trial.
Public title
The effect of nitrate-rich beetroot juice supplementation on sport performance
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
age 18 to 22 years at least 5 years of sports experience check to participate in the study body mass between 20 and 30 having three to five exercise sessions per week
Exclusion criteria:
Consumption of sports supplements such as creatine, caffeine and sodium bicarbonate in the last week Suffering from a chronic disease (diabetes, hypertension, kidney or lung disease, cancer) Having allergy to food rich in nitrate-rich beetroot juice and compounds containing it smoking Having exercise damage in the last 6 months Players who use energy supplements during the last three months. The habit of drinking coffee during the day
Age
From 18 years old to 22 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Actual sample size reached: 18
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization will be used to distribute individuals and the randomization unit will be individuals. This randomization will be done in a stratified manner so that 20 soccer players will be placed in two strata, male and female (stratified randomization). 10 people will be included in each stratum. The randomization tool in this study will be sealed envelopes so that each person in each stratum will be given a specific code and these codes will be placed in sealed envelopes and then the individuals will be distributed into two groups using a lottery. Given that all participants in this study will be known in advance and will be present on the day of sampling, a person unaware of the study objectives will distribute the sealed envelopes into the two groups (allocation concealment). Therefore, due to the simple randomization method in this study, there is no need to create a random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial. The nitrate-rich beet juice and normal beet juice will be packed identically in terms of (color, shape and smell) in similar 140 cc bottles. Patients, researchers who are responsible for sampling and evaluating tests and statistical analyzes will be blinded.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculties of Pharmacy and Nutrition, Isfahan University of Medical Sciences
Street address
Isfahan, Hazar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8177843191
Approval date
2024-05-20, 1403/02/31
Ethics committee reference number
IR.MUI.PHANUT.REC.1403.034

Health conditions studied

1

Description of health condition studied
The studied state of physical performance of soccer players
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum levels of nitrate
Timepoint
Baseline and 150 min after nitrate-rich beet root juice
Method of measurement
ELISA method

2

Description
Serum levels of Nitric oxide
Timepoint
Baseline and 150 min after nitrate-rich beet root juice
Method of measurement
ELISA method

3

Description
Serum levels of Nitrite
Timepoint
Baseline and 150 min after nitrate-rich beet root juice
Method of measurement
ELISA method

Secondary outcomes

1

Description
Aerobic capacity
Timepoint
Baseline and 150 min after nitrate-rich beet root juice
Method of measurement
Mobile Garmin Software

2

Description
Counter movement jump(CMJ)
Timepoint
Baseline and 150 min after nitrate-rich beet root juice
Method of measurement
Mobile Garmin Software

3

Description
30 meters of sprint
Timepoint
Baseline and 150 min after nitrate-rich beet root juice
Method of measurement
Timer

4

Description
Maximum Heart Rate
Timepoint
Baseline and 150 min after nitrate-rich beet root juice
Method of measurement
Mobile Garmin Software

5

Description
Average Heart Rate
Timepoint
Baseline and 150 min after nitrate-rich beet root juice
Method of measurement
Blood pressure monitor

Intervention groups

1

Description
Intervention group: Participants in the intervention group will receive 140 ml of nitrate-rich beetroot juice 30 minutes after breakfast. This supplement will be supplied by BeetIt-Pro Elite Shot, James White Drinks, UK.
Category
Other

2

Description
Control group: 140 ml of regular beetroot juice will be received by the subjects in the placebo group 30 minutes after breakfast. The steps for producing regular beetroot juice will be such that first, fresh red beets will be prepared and then washed, peeled and chopped. The beets will be cooked for 90 minutes at 100 degrees Celsius in a commercial oven that does not change the nitrate content and then the juice created by cooking the beets will be used as a placebo. Also, in order to create a similar taste to the nitrate-enriched beetroot juice supplement, 12 grams of sugar will be added to every 70 ml of regular beetroot juice.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Silo Gym
Full name of responsible person
Omid Sadeghi
Street address
Isfahan, Freiburg St
City
Isfahan
Province
Isfehan
Postal code
817783191
Phone
+98 913 453 0498
Email
omidsadeghi69@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Omid Sadeghi
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Nutrition
City
Isfahan
Province
Isfehan
Postal code
8177843191
Phone
+98 31 3792 3174
Email
omidsadeghi69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Omid Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Nutrition
City
Isfahan
Province
Isfehan
Postal code
8177843191
Phone
+98 31 3792 3174
Email
omidsadeghi69@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Omid Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Nutrition
City
Isfahan
Province
Isfehan
Postal code
8177843191
Phone
+98 31 3792 3174
Email
omidsadeghi69@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Omid Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Nutrition
City
Isfahan
Province
Isfehan
Postal code
8177843191
Phone
+98 31 3792 3174
Email
omidsadeghi69@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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