Protocol summary

Study aim
Determining the effects of electrical stimulation of the brain and dark chocolate on physiological and cognitive function and perceptual responses during and after debilitating endurance activity in hypoxia And mental fatigue
Design
This research will have an intervention group and a control group, double-blind and randomized with a within-group design and counterbalancing. Latin square method and www.random.org site are used for randomization.
Settings and conduct
Hypoxia through the hypoxia device, mental fatigue with the Stroop test software, supplement (dark and white chocolate) and direct transcranial stimulation of the brain with the tDCS device. Razi University Faculty of Sports Science Laboratory.Subjects and the lead researcher will not be aware of the type of stimulation received in each session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 18 to 44 years Active cyclist under the supervision of Kermanshah city cycling board Regular cycling training in the last six months at least three sessions a week Obtaining a certificate of non-prohibition from participating in an exercise program from a physician Being right-handed. Criteria for barring entry to the research: Climbing to an altitude of over 2000 meters in the past month Having any cardiovascular, pulmonary and metabolic diseases The presence of implantable or pacemaker devices in the body Tobacco and alcohol consumption
Intervention groups
Intervention: It is a group that receives the interventions of anodal electrical stimulation, sham stimulation and dark chocolate. Control: the group that consumes white chocolate. Each subject will be randomly examined in four conditions.
Main outcome variables
Time to exhaustion; Electromyography; Rate of perceived exertion; Sense of pleasure; Arousal; Reaction time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220417054556N1
Registration date: 2022-07-27, 1401/05/05
Registration timing: registered_while_recruiting

Last update: 2022-07-27, 1401/05/05
Update count: 0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
parisa banaei
Name of organization / entity
Faculty of Sports Sciences, Razi University
Country
Iran (Islamic Republic of)
Phone
+98 81 3492 3788
Email address
p.banayi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-07-29, 1401/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of transcranial direct current stimulation and dark chocolate supplementation on athletic and cognitive performance in normobaric hypoxia after inducing mental fatigue in men cyclists
Public title
The effect of transcranial direct current stimulation and dark chocolate on cyclists' athletic and cognitive performance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Active cyclist under the supervision of Kermanshah city cycling board Regular cycling practice for the past six months at least three times a week Obtaining a certificate of non-prohibition from participating in an exercise program from a physician Being right-handed Age range 18 to 44 years
Exclusion criteria:
Age
From 18 years old to 44 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 12
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the order of subjects' exposure to four different conditions, the Latin square method will be used. To do this, first using the site www.random.org, each subject will be randomly assigned a number between 1 and 12 as the identification code. Then, the English letters A, B, C, and D are assigned to the four intervention terms, and a Latin square with four rows and four columns is created. After creating the Latin square, participants 1 to 3 in the first row sequence, participants 4 to 6 in the second row sequence, participants 7 to 9 in the third row sequence, and participants 10 to 12 in the sequence Sequences will be placed in the fourth row.
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects and the researcher will not be aware of the type of stimulation received in each session and this information will be available only to someone outside the research team until the end of the research. In order to conceal the order of receiving the stimulus from the researcher, all the steps related to randomly determining the order of receiving the stimulus in each subject will be performed by the same person outside the research team. Also, in order to hide the type of stimulation in each session of the subjects, the tDCS device is hidden from the subjects by a cover and the researcher will not be present in the laboratory during the installation of the electrodes and at the end of 20 minutes and the time of electrode separation.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Razi University
Street address
Razi University, Tagh-e-Bostan, University St.
City
kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.RAZI.REC.1401.005

Health conditions studied

1

Description of health condition studied
Hypoxia
ICD-10 code
ICD-10 code description

2

Description of health condition studied
mental fatigue
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Endurance sports performance
Timepoint
Before starting the intervention and every 3 minutes from the beginning of the test to exhaustion in each session for 4 weeks
Method of measurement
The Astrand test for men is used to measure the maximum power output of the subjects.

2

Description
Cognitive function
Timepoint
Before starting the intervention and every 3 minutes from the beginning of the test to exhaustion in each session for 4 weeks
Method of measurement
A reaction time test is used.

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group: 2: sham stimulation-dark chocolate, 1: anodal stimulation-dark chocolate." . In both groups of stimulation, after installing the electrodes, the subjects will receive anodal and sham electrical stimulation with a intensity of 2 mA crosswise in a sitting position and one session per week (for 4 weeks) for 20 minutes. Chocolate supplement Bitter (467 kcal of dark chocolate (Nestle-70%) will also be received cross-over each week for four weeks.
Category
Prevention

2

Description
"Control group: 1:Anodal stimulation- White chocolate, 2:Sham stimulation-White chocolate." In both groups of stimulation, after installing the electrodes, the subjects will receive anodal and sham electrical stimulation with a intensity of 2 mA crosswise in a sitting position and one session per week (for 4 weeks) for 20 minutes. They will also receive white chocolate supplements ((487 kcal from Nestle white chocolate)) cross-over each week for four weeks.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi University
Full name of responsible person
Parisa Banaei
Street address
Razi University, University Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
p.banayi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Ali Heyrani
Street address
Razi University., Daneshgah St.,Taghbestan.
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
p.banayi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University
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
Razi University
Full name of responsible person
Parisa Banaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Razi University., Faculty of Sports Sciences., University Blvd., Taq Bostan,
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
p.banayi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Razi University., Faculty of Sports Sciences., University Blvd., Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
vtadibi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Parisa Banaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Razi University., Faculty of Sports Sciences., University Blvd., Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
p.banayi@yahoo.com

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 is no more information
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
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
Total data
When the data will become available and for how long
Start access 6 months after printing results
To whom data/document is available
researchers
Under which criteria data/document could be used
For meta-analytic research
From where data/document is obtainable
vahid tadibi
What processes are involved for a request to access data/document
Maximum one month after application
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