Protocol summary

Study aim
Caffeine increases the activity of the sympathetic nervous system in healthy people, changes in the nervous system can be assessed using heart rate variability. The aim of this study was to evaluate the effect of caffeine dose on the recovery of some indicators of the autonomic nervous system after endurance activity.
Design
Subjects were referred to the laboratory in 3 separate sessions with an interval of at least 3 and a maximum of 6 days of wash-out. In the laboratory, after 15 minutes in a sitting position, HR, SBP, DBP, and HRV were measured and after eating the same breakfast containing 540 kcal capsules containing doses of 6 and 9 mg/kg body weight of caffeine or placebo. They received 300 ml of water with the single-blind method.
Settings and conduct
Exercise Physiology Laboratory, Faculty of Physical Education and Sports Sciences, Guilan University. After supplementation to maximize caffeine concentration in the blood, subjects were seated for 35 minutes. Immediately after that, they started running on a treadmill for 12 minutes, equivalent to 75% of the maximum oxygen consumption. After the activity, there was a 60-minute recovery phase in which HRV levels were recorded at 10-minute intervals.
Participants/Inclusion and exclusion criteria
Men trained with VO2max at least 50 with a history of at least 2 years of regular exercise, with good body composition, no history of acute and chronic diseases, no history of smoking, no cardiovascular problems, no anabolic steroids or central nervous system stimulant And other sports supplements in the last 6 months
Intervention groups
Caffeine dose groups of 6 and 9 mg/kg body weight
Main outcome variables
Parameters related to heart rate variability (RMSSD and LF/HF), systolic and diastolic blood pressure, myocardial oxygen cost, RPP, pain sensation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190720044283N4
Registration date: 2021-10-27, 1400/08/05
Registration timing: retrospective

Last update: 2021-10-27, 1400/08/05
Update count: 0
Registration date
2021-10-27, 1400/08/05
Registrant information
Name
Siamand Abdollahpour
Name of organization / entity
Guilan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0274
Email address
siamand.abp1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-26, 1400/07/04
Expected recruitment end date
2021-10-27, 1400/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of caffeine dose on heart rate variability, rate pressure product and some fatigue indexes after endurance exercise in trained men
Public title
Caffeine Dose and Autonomic Recovery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects have exercised regularly (three sessions per week or more) over the past two years None of the subjects used supplements or ergogenic aids. No use of anabolic steroids or central nervous system stimulants in the last two years No caffeine intake of more than 300 mg per day No history of cardiovascular and metabolic diseases No history of alcohol and tobacco use Optimal body composition and physical health
Exclusion criteria:
Age
From 18 years old to 22 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 12
More than 1 sample in each individual
Number of samples in each individual: 3
The control group, the low-dose intervention group and the high-dose intervention group
Randomization (investigator's opinion)
Randomized
Randomization description
Use the random selection method by Excel software. In this method, we first enter the names of the subjects in Excel, and then in another part, we specify the position of the desired groups in two separate sections of 6 subjects. Then in these two sections, we will execute the following code so that people are randomly placed in groups of 6 subjects. =INDEX($A$3:$A$12,RANDBETWEEN(1,ROWS($A$3:$A$12)),1)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, subjects were not aware of how caffeine or placebo was distributed. The determined amount of supplement and placebo was weighed for each subject separately and was delivered to the subjects by coding by the laboratory operator on each day of the test.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Sports Science Institute (SSRI)
Street address
Fifth Alley, Mir Emad St., Ostad Motahhari St.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2021-09-15, 1400/06/24
Ethics committee reference number
IR.SSRI.REC.1400.1230

Health conditions studied

1

Description of health condition studied
Recovery of indicators of the autonomic nervous system
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Heart rate variability
Timepoint
15 minutes after attending the laboratory (before breakfast), 35 minutes after supplementation, immediately and at 1, 2, 3, 5, 10, 20, 40, and 60 minutes after exercise
Method of measurement
Heart rate monitor (Polar-H10)

2

Description
Systolic and diastolic blood pressure
Timepoint
15 minutes after attending the laboratory (before breakfast), 35 minutes after supplementation, immediately and at 1, 2, 3, 5, 10, 20, 40, and 60 minutes after exercise
Method of measurement
hand barometer (Zenith, ZTH-5001, Switzerland)

3

Description
Rate pressure product
Timepoint
At all points when heart rate and blood pressure will also be measured.
Method of measurement
It is calculated by multiplying systolic blood pressure and heart rate.

4

Description
Rate of Perceived Exertion (RPE)
Timepoint
Immediately after exercise
Method of measurement
Borg scale (6-20)

5

Description
Muscle Pain
Timepoint
Immediately after exercise until one hour after exercise
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dose of 6 mg/kg of caffeine and endurance activity
Category
N/A

2

Description
Intervention group: Dose of 9 mg/kg of caffeine and endurance activity
Category
N/A

3

Description
Control group: Taking placebo along with performing endurance activity
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Physical Education and Sports Sciences
Full name of responsible person
Dr. Javad Mehrabani
Street address
5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3366 9027
Email
int@guilan.ac.ir
Web page address
https://fe.guilan.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Guilan
Full name of responsible person
Javad Mehrabani
Street address
District 5, Rasht, Gilan Province
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0274
Email
Siamand.abp1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Guilan
Proportion provided by this source
1
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
Faculty of Physical Education and Sports Sciences, University of Guilan
Full name of responsible person
Dr. Javad Mehrabani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
8 km of Tehran road, Faculty of Physical Education and Sports Sciences, University of Guilan
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 911 230 9074
Email
mehrabanij@guilan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Physical Education and Sports Sciences, University of Guilan
Full name of responsible person
Dr. Javad Mehrabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
8 km of Tehran road, Faculty of Physical Education and Sports Sciences, University of Guilan
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 911 230 9074
Email
mehrabanij@guilan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Siamand Abdolahpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physical Education and Sport Science
Street address
District 5, Rasht, Gilan Province
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0274
Email
Siamand.abp1@gmail.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
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
After analyzing the data, only part of the data related to the main outcome will be shared.
When the data will become available and for how long
After approval by the journal publishing the study report
To whom data/document is available
Journal publisher of study reports
Under which criteria data/document could be used
By getting permission from the journal publish the study report
From where data/document is obtainable
Journal publisher of study reports
What processes are involved for a request to access data/document
Public and private terms Journal of the study report
Comments
Loading...