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Investigating the effects of a period of Ginseng Consumption on Exercise and Cognitive Performance in Sports Science Female Students during Hypoxia Condition after taking Acetazolamide

Protocol summary

Study aim
Examining the effects of ginseng on sports and cognitive performance in hypoxic conditions after taking acetazolamide
Design
This research project will include 10 female students of Razi University's physical education department. This research has 2 groups, one group will use ginseng and the other group will use placebo. This research is a type of laboratory research that will be double-blind, block-randomized using the Random Allocation softwarer, with an intra-group and counterbalanced design, and it has a clinical trial phase of 3.
Settings and conduct
Hypoxia through a hypoxia device. Place: Razi University Faculty of Sports Sciences laboratory
Participants/Inclusion and exclusion criteria
Entry requirements: Razi University students aged 18 to 29, body mass index 18.5 to 24.9, regular aerobic activity program in the 6 months before the start of the research. Conditions of non-entry: having a chronic disease, a history of cognitive disorders or neurological diseases, taking any sports supplements in the two months before the start of the research, and a history of staying at altitudes of more than 2000 meters in the two months before the start of the research.
Intervention groups
Supplemental group: the group that will take ginseng. Control group: the group that will take a placebo.
Main outcome variables
Evaluation of the time to collapse in normobaric hypoxia, evaluation of pressure perception in normobaric hypoxia, evaluation of heart rate in normobaric hypoxia, evaluation of arterial oxygen saturation in normobaric hypoxia, evaluation of cognitive function in normoxia, evaluation of cognitive function in normobaric hypoxia, evaluation of subsequent cognitive function Residual aerobic activity in normobaric hypoxia conditions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220523054967N1
Registration date: 2022-10-03, 1401/07/11
Registration timing: prospective

Last update: 2022-10-03, 1401/07/11
Update count: 0
Registration date
2022-10-03, 1401/07/11
Registrant information
Name
Mohana IzadiTabar
Name of organization / entity
The University of Razi
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 7605
Email address
mezady75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-11-05, 1401/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of a period of Ginseng Consumption on Exercise and Cognitive Performance in Sports Science Female Students during Hypoxia Condition after taking Acetazolamide
Public title
The effects of ginseng on sports and cognitive performance in hypoxia conditions after taking acetazolamide
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female students in the field of physical education (third semester of bachelor's degree and above) Place of residence and education in Kermanshah city Age range of 18 to 29 years Body mass index between 18.5 and 24.9 Having general health to participate in sports activities with the doctor's approval Regular aerobic exercise program in the 6 months before the beginning of the research
Exclusion criteria:
Suffering from any chronic disease History of cognitive disorders or neurological diseases Being pregnant Excessive bleeding during menstruation History of allergies and sensitivities Consumption of any sports supplement in two months before the beginning of the research Smoking and alcohol consumption Blood donation in 2 months before the beginning of the research History of staying at altitudes of more than 2000 meters in the two months before the beginning of the research
Age
From 18 years old to 29 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Someone other than researchers will use random allocation software with block randomization method to group subjects. During the grouping process, each subject will be assigned a unique identification code, which will be provided to the main researchers along with the intended intervention (ginseng or placebo). The unique identification code is used as a label to identify the group of each subject after the end of the research. The random allocation software can perform block randomization. The sample size and the names of the two groups (ginseng and placebo) are defined in the main randomization menu. Then, the block design with equal blocks is entered. Also, the formatting of the unique identification code is defined with a specific number of digits. The final step is to create a random list in which the unique identification code and group name will be specified for each number.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because the study was double-blind, the subjects and the researchers did not know who would take ginseng or a placebo, and someone else would check the results. Also, in order not to distinguish the drug and the placebo, they will be prepared in the same capsules and the placebo group will use maltodextrin.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Razi University of Kermanshah
Street address
Taq Bostan, University Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2022-04-27, 1401/02/07
Ethics committee reference number
IR.RAZI.REC.1401.012

Health conditions studied

1

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

Primary outcomes

1

Description
Endurance sports performance
Timepoint
After taking ginseng or placebo and after applying hypoxia
Method of measurement
Astrand test for women is used to measure the maximum power of the subjects.

2

Description
Simple visual reaction time
Timepoint
At the beginning of the study to evaluate the level of cognitive function, after taking ginseng or placebo and before and after applying hypoxia
Method of measurement
Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA)

3

Description
Simple auditory reaction time
Timepoint
At the beginning of the study to evaluate the level of cognitive function, after taking ginseng or placebo and before and after applying hypoxia
Method of measurement
Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA)

4

Description
Selective visual reaction time
Timepoint
At the beginning of the study to evaluate the level of cognitive function, after taking ginseng or placebo and before and after applying hypoxia
Method of measurement
Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA)

5

Description
Combined reaction time
Timepoint
At the beginning of the study to evaluate the level of cognitive function, after taking ginseng or placebo and before and after applying hypoxia
Method of measurement
Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA)

Secondary outcomes

empty

Intervention groups

1

Description
Complementary group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the reaction time test in normal conditions and simulated altitude conditions and the aerobic fitness test in simulated altitude conditions. They take ginseng for two weeks and on the last day (the day before the test) they take acetazolamide and on the day of the test they take the last dose of ginseng and acetazolamide. In other words, they consume ginseng for a period of two weeks. A one-week grace period will be considered.
Category
Prevention

2

Description
Placebo group: apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the reaction time test in normal conditions and simulated altitude conditions and the aerobic fitness test in simulated altitude conditions. They take a placebo for two weeks, and on the last day (the day before the test), they take acetazolamide, and on the day of the test, they take the last dose of placebo and acetazolamide. In other words, they take a placebo for a period of two weeks. A one-week grace period will be considered.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi University
Full name of responsible person
Mohana Izadi Tabar
Street address
Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
mezady75@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Razi
Full name of responsible person
ali heirani
Street address
Taq Bostan, University Street, Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
a.heirani@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Razi
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
The University of Razi
Full name of responsible person
Vahid Tadibi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@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
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Razi
Full name of responsible person
Vahid Tadibi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@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 further 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
The access period starts 6 months after the results are published
To whom data/document is available
researchers
Under which criteria data/document could be used
For meta-analysis research
From where data/document is obtainable
Vahid Tadibi
What processes are involved for a request to access data/document
A maximum of one month after the request
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