Protocol summary

Study aim
Evaluate Acute caffeine supplementation along with beet juice effect on vasodilatory and performance factors in elite runners.
Design
Quantitative research of semi-experimental-field laboratory with targeted selection of professional runners randomly, cross-sectionally, cross-sectionally and three-blind with 3 groups, each group received all three complementary doses, so each group is considered as its own control group The realized sample size was 10 people. Randomization using dice throws both for how the first, second and third groups are selected and what dose each group receives for the first, second and third stages.
Settings and conduct
Blood sampling test and two 5000 aerobics in the Sports Medicine Center and assessment and evaluation of the National Olympic and Paralympic Academy
Participants/Inclusion and exclusion criteria
Professional male runners aged 18 to 30 with at least 3 training sessions per week.Participants were asked not to eat any diet containing nitrate or caffeine for 24 hours prior to the experiment, including sausages, processed meats, pastes, coffee, chewing gum, syrups, tea, and tobacco. For this reason, participants were given a list of all dietary sources. They were asked not to exercise heavily for 72 hours before the test.
Intervention groups
Intervention and control group 1: High dose of combined supplement (9.6 mmol nitrate in beet juice made by Sensei Pharmaceutical Company and 400 mg of caffeine made by Karen Pharmaceutical Company) which is combined with 250 cc of water. The group received all three complementary doses crossover and randomly, so each intervention group is considered as its control group.
Main outcome variables
Heart rate, systolic and diastolic blood pressure, endothelin-1 [ET-1], collagen 18, nitric oxide [NO] and nitrite levels were measured

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200707048041N1
Registration date: 2020-08-23, 1399/06/02
Registration timing: retrospective

Last update: 2020-08-23, 1399/06/02
Update count: 0
Registration date
2020-08-23, 1399/06/02
Registrant information
Name
Hadi Atarod
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2621 6193
Email address
atarodsportnutrition@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-24, 1398/12/05
Expected recruitment end date
2020-03-14, 1398/12/24
Actual recruitment start date
2020-04-08, 1399/01/20
Actual recruitment end date
2020-06-09, 1399/03/20
Trial completion date
2020-06-19, 1399/03/30
Scientific title
The effect of short-term supplementation of caffeine and beet juice with high, low dose and placebo on vasodilator indices and athletic performance in elite runners
Public title
Evaluation of vasodilatory changes and exercise performance to caffeine-beet juice supplementation in runners
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No history of metabolic disease No history of smoking Intolerance to beet juice, caffeine or other natural stimulants Do not use the drug during the research period Young elite male runners Ability to perform aerobic activity
Exclusion criteria:
Having metabolic diseases such as heart disease and hypertension History of drug use History of tobacco use Having an intolerance to caffeine Having an intolerance to beet-root juice Non-runner Female gender
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Actual sample size reached: 10
Randomization (investigator's opinion)
Randomized
Randomization description
First, the total sample size of 30 people consisting of members of the national endurance athletics team of the country who met the conditions in the descriptive questionnaire and had physical, health and sports conditions were determined. Then they were divided into 3 random groups so that their names were written in the same way on the same sheets and 10 of them were selected by an unrelated person for each group and divided into three groups. The names were randomly determined without replacement from the container and the order of supplementation was determined.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Subjects participating in the project, as well as the researcher who did not know the type of supplement offered to the subjects, and the collection was done only based on the number of each group and the analytical laboratory not knew the names of the individuals in each intervention group and the type of supplement they consumed
Placebo
Used
Assignment
Crossover
Other design features
Design the use of combination supplements with simultaneous random, cross-sectional, and Three-way blind intervention

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research، Islamic Azad University, Science and Research Branch
Street address
Research Sciences Branch، Islamic Azad University، Hesarak St، Punak
City
Tehran
Province
Tehran
Postal code
Approval date
2020-02-21, 1398/12/02
Ethics committee reference number
IR.IAU.SRB.REC.1399.005

Health conditions studied

1

Description of health condition studied
Changes in nitrite, collagen 18, nitrous oxide, endothelin-1, systolic blood pressure, diastolic blood pressure and heart rate in professional runners due to caffeine-beet juice supplementation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Heart rate
Timepoint
The first and seventh days before and after two 5 km, which lasts a total of 14 days for each stage of the intervention. This protocol is repeated in three stages and the consumption of supplements and subjects is changed.
Method of measurement
Holter

2

Description
Systolic blood pressure
Timepoint
The first and seventh days before and after two 5 km, which lasts a total of 14 days for each stage of the intervention. This protocol is repeated in three stages and the consumption of supplements and subjects is changed.
Method of measurement
Mercury barometer

3

Description
Diastolic blood pressure
Timepoint
The first and seventh days before and after two 5 km, which lasts a total of 14 days for each stage of the intervention. This protocol is repeated in three stages and the consumption of supplements and subjects is changed.
Method of measurement
Mercury barometer

4

Description
Nitrate
Timepoint
The first, second, seventh and eighth days of the intervention in the first phase of the intervention, which lasts a total of 14 days. This protocol is repeated in three stages and the consumption of supplements and subjects is changed.
Method of measurement
Blood sampling

5

Description
Nitric oxide
Timepoint
The first, second, seventh and eighth days of the intervention in the first phase of the intervention, which lasts a total of 14 days. This protocol is repeated in three stages and the consumption of supplements and subjects is changed.
Method of measurement
Blood sampling

6

Description
Collagen 18
Timepoint
The first, second, seventh and eighth days of the intervention in the first phase of the intervention, which lasts a total of 14 days. This protocol is repeated in three stages and the consumption of supplements and subjects is changed.
Method of measurement
Blood sampling

7

Description
Endothelin 1
Timepoint
The first, second, seventh and eighth days of the intervention in the first phase of the intervention, which lasts a total of 14 days. This protocol is repeated in three stages and the consumption of supplements and subjects is changed.
Method of measurement
Blood sampling

Secondary outcomes

empty

Intervention groups

1

Description
IIntervention and control group 1: High dose of combined supplement (9.6 mmol nitrate in beet juice made by Sensei Pharmaceutical Company and 400 mg of caffeine made by Karen Pharmaceutical Company) which is combined with 250 cc of water. The group received all three complementary doses crossover and randomly, so each intervention group is considered as its control group.
Category
Rehabilitation

2

Description
Intervention and control group 2: Low dose of combined supplement (4.8 mmol nitrate in beet juice made by Sensai Pharmaceutical Company and 200 mg of caffeine made by Karen Pharmaceutical Company) combined with 250 cc of water. Due to the fact that all three groups received all three complementary doses crossover and randomly, each intervention group is considered as its control group.
Category
Rehabilitation

3

Description
Intervention and control group 3: placebo group Natural beet juice with 1 mmol nitrate and decaffeinated. Due to the fact that all three groups received all three complementary doses crossover and randomly, each intervention group is considered as its control group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Medicine Center of the National Olympic Academy
Full name of responsible person
Dr.Seyed Shamseddin Taghavi
Street address
National Olympic Academy، Enghelab Sports Complex، Seoul street
City
Tehran
Province
Tehran
Postal code
1995614336
Phone
+98 21 2621 6193
Fax
+98 21 2621 6195
Email
nopa.ir@gmail.com
Web page address
http://academy.olympic.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Olympic Academy
Full name of responsible person
Dr.Reza Gharakhanlu
Street address
National Olympic Academy، Enqelab Sports Complex، Seoul Street
City
Tehran
Province
Tehran
Postal code
1995614336
Phone
+98 21 2621 6188
Fax
+98 21 2621 6204
Email
nopa.ir@gmail.com
Web page address
http://academy.olympic.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Olympic Academy
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hadi Atarod
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Science and Research Branch, Islamic Azad University, University Square, Hesarak Boulevard, pounak
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 2621 6193
Fax
+98 21 2621 6195
Email
atarodsportnutrition@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Farshad Ghazalian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Science and Research Branch، Islamic Azad University، University Square، Hesarak Boulevard، pounak
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
0098 21 44865179-82
Fax
+98 21 4486 5179
Email
phdghazalian@gmail.com
Web page address
http://human.srbiau.ac.ir/fa

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Farshad Ghazalian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Science and Research Branch، Islamic Azad University، University Square، Hesarak Boulevard، pounak
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
0098 21 44865179-82
Fax
+98 21 4486 5179
Email
phdghazalian@gmail.com
Web page address
http://human.srbiau.ac.ir/fa

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are no plans to publish. If a researcher needs the information of the participants, he / she can contact the person in charge of the article or the editor of the publication where the article is published, so that the participants can provide details if they wish.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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