Investigating the effect of Ginkgo biloba consumption on exercise and cognitive performance in male mountaineers under hypoxia condition after taking Acetazolamide
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General information
empty
Typing error, the name of the drug was given incorrectly in the intervention groups section of the placebo.
Typing error, the name of the drug was given incorrectly in the intervention groups section of the placebo.
empty
اشتباه تایپی، در قسمت گروه های مداخله در بخش دارونما به اشتباه اسم دارو آورده شده بود.
اشتباه تایپی، در قسمت گروه های مداخله در بخش دارونما به اشتباه اسم دارو آورده شده بود.
Health conditions studied
#1
The participants are healthy and trained male mountaineer.
The participants are healthy and trained male mountaineer.
شرکت کنندگان مردان کوهنورد سالم و تمرین کرده می باشند.
شرکت کنندگان مردان کوهنورد سالم و تمرین کرده می باشند.
Intervention groups
#1
Placebo group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the Stroop test and reaction time in normal conditions and simulated altitude conditions and the submaximal aerobic test in simulated altitude conditions. . Subjects take ginkgo biloba for five days and take acetazolamide on the last day (the day before the test) and take the last dose of ginkgo biloba and acetazolamide on the day of the test. In other words, they consume ginkgo biloba for a period of five days. A one-week grace period will be considered.
placebo group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the Stroop test and reaction time in normal conditions and simulated altitude conditions and the submaximal aerobic test in simulated altitude conditions. Subjects take for five days and take acetazolamide on the last day (the day before the test) and take the last dose of placebo and acetazolamide on the day of the test. In other words, they consume placebo for a period of five days. A one-week grace period will be considered.
Placeboplacebo group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the Stroop test and reaction time in normal conditions and simulated altitude conditions and the submaximal aerobic test in simulated altitude conditions. . Subjects take ginkgo biloba for five days and take acetazolamide on the last day (the day before the test) and take the last dose of ginkgo bilobaplacebo and acetazolamide on the day of the test. In other words, they consume ginkgo bilobaplacebo for a period of five days. A one-week grace period will be considered.
گروه دارونما: جدای از جلسات آشنایی و اندازه گیریهای اولیه، آزمودنیها دو بار در آزمایشگاه حضور مییابند و آزمون استروپ و زمان عکس العمل را در شرایط معمول و شرایط ارتفاع شبیهسازی شده و تست هوازی زیر بیشینه وامانده ساز را در شرایط ارتفاع شبیهسازی انجام می دهند. آزمودنی ها به مدت پنج روز جینکوبیلوبا مصرف میکنند و در آخرین روز (روز قبل از آزمون) داروی استازولامید و در روز آزمون آخرین دوز جینکوبیلوبا و استازولامید را مصرف میکنند. به عبارتی برای یک دوره پنج روزه جینکوبیلوبا مصرف میکنند. یک هفته دوره زدایش در نظر گرفته خواهد شد.
گروه دارونما: جدای از جلسات آشنایی و اندازه گیریهای اولیه، آزمودنیها دو بار در آزمایشگاه حضور مییابند و آزمون استروپ و زمان عکس العمل را در شرایط معمول و شرایط ارتفاع شبیهسازی شده و تست هوازی زیر بیشینه وامانده ساز را در شرایط ارتفاع شبیهسازی انجام می دهند. آزمودنی ها به مدت پنج روز دارونما مصرف میکنند و در آخرین روز (روز قبل از آزمون) داروی استازولامید و در روز آزمون آخرین دوز دارونما و استازولامید را مصرف میکنند. به عبارتی برای یک دوره پنج روزه دارونما مصرف میکنند. یک هفته دوره زدایش در نظر گرفته خواهد شد.
گروه دارونما: جدای از جلسات آشنایی و اندازه گیریهای اولیه، آزمودنیها دو بار در آزمایشگاه حضور مییابند و آزمون استروپ و زمان عکس العمل را در شرایط معمول و شرایط ارتفاع شبیهسازی شده و تست هوازی زیر بیشینه وامانده ساز را در شرایط ارتفاع شبیهسازی انجام می دهند. آزمودنی ها به مدت پنج روز جینکوبیلوبادارونما مصرف میکنند و در آخرین روز (روز قبل از آزمون) داروی استازولامید و در روز آزمون آخرین دوز جینکوبیلوبادارونما و استازولامید را مصرف میکنند. به عبارتی برای یک دوره پنج روزه جینکوبیلوبادارونما مصرف میکنند. یک هفته دوره زدایش در نظر گرفته خواهد شد.
Protocol summary
Study aim
Investigating the effects of ginkgo biloba on exercise and cognitive performance in hypoxic conditions after taking acetazolamide
Design
This research project will include 12 mountaineers living in Kermanshah. This research has 2 groups, one group will use ginkgo biloba and the other group will use placebo. This research is a type of laboratory research that will be double-blind, block-randomized using Random Allocation Software, with an intra-group design and counterbalanced, and it has a phase 3 clinical trial.
Settings and conduct
Hypoxia through a hypoxia device.
Place: Razi University Faculty of Sports Sciences laboratory.
Participants/Inclusion and exclusion criteria
Active mountaineer men aged 18 to 44 (record of climbing to altitudes higher than 4000 meters and regular climbing activity in the last year), A history of AMS in previous nights at altitudes above 3000 meters, Body mass index between 18.5 and 24.9, Having general health to participate in sports activities approved by a doctor, Regular aerobic exercise in the 6 months before the beginning of the research
Intervention groups
Ginkgo biloba group: The group that will consume ginkgo biloba.
Control group: the group that will take a placebo.
Main outcome variables
1. Evaluation of the time to reach paralysis in normobaric hypoxia conditions
2. Evaluation of pressure perception, sensation scale, arousal scale, heart rate and arterial blood oxygen saturation before and after reaching collapse in normobaric hypoxia conditions
3. Evaluation of cognitive function in normoxia conditions, before and after reaching paralysis in normobaric hypoxia conditions
General information
Reason for update
Typing error, the name of the drug was given incorrectly in the intervention groups section of the placebo.
Acronym
IRCT registration information
IRCT registration number:IRCT20230711058744N1
Registration date:2023-07-20, 1402/04/29
Registration timing:retrospective
Last update:2023-12-09, 1402/09/18
Update count:1
Registration date
2023-07-20, 1402/04/29
Registrant information
Name
Sara Mansouri
Name of organization / entity
The University of Razi
Country
Iran (Islamic Republic of)
Phone
+98 83 3466 2138
Email address
saramansourii1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-05, 1401/12/14
Expected recruitment end date
2023-04-18, 1402/01/29
Actual recruitment start date
2023-04-24, 1402/02/04
Actual recruitment end date
2023-05-28, 1402/03/07
Trial completion date
2023-06-19, 1402/03/29
Scientific title
Investigating the effect of Ginkgo biloba consumption on exercise and cognitive performance in male mountaineers under hypoxia condition after taking Acetazolamide
Public title
The effects of Ginkgo biloba on exercise and cognitive performance in hypoxic conditions after taking acetazolamide
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Active mountaineer men aged 18 to 44 years (history of climbing to altitudes higher than 4000 meters and regular climbing activity in the past one year)
History of AMS in previous nights at altitudes higher than 3000 meters
Body mass index between 18.5 and 24.9
Having general health to participate in sports activities approved by the doctor
Regular aerobic exercise in 6 months before the beginning of the research (at least three sessions per week, including hiking)
Exclusion criteria:
Suffering from any chronic disease
History of cognitive disorders or neurological diseases
History of allergies and sensitivities
Use of any sports supplements in the two months before the start of the study
Smoking and alcohol consumption
Donating blood in the 2 months before the start of the study
History of staying at higher altitudes From 2000 meters in two months before the beginning of the research, sleeping at an altitude above 2700 meters in two weeks before the beginning of the research
Taking acetazolamide drug in two weeks before the beginning of the research
Allergy to acetazolamide and sulfonamides
Suffering from color blindness.
Age
From 18 years old to 44 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
12
Actual sample size reached:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Someone other than researcher 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 (ginkgo biloba 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 (ginkgo biloba 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 study subjects and researchers did not know who would take ginkgo biloba 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
2023-03-01, 1401/12/10
Ethics committee reference number
IR.RAZI.REC.1402.014
Health conditions studied
1
Description of health condition studied
The participants are healthy and trained male mountaineer.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in the time to reach exhaustion in a submaximal endurance exercise under hypoxic conditions
Timepoint
After administration of ginkgo biloba or placebo under hypoxic conditions
Method of measurement
Record time using a stopwatch
2
Description
Selective visual reaction time
Timepoint
At the beginning of the study to evaluate the level of cognitive function, after taking ginkgo biloba 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
Cognitive function
Timepoint
At the beginning of the study to evaluate the level of cognitive function, after taking ginkgo biloba or placebo and before and after applying hypoxia
Method of measurement
Using the color-word Stroop test
4
Description
sense of pleasure
Timepoint
Before and after reaching exhaustion in a submaximal endurance exercise under normobaric hypoxia conditions
Method of measurement
Using an 11-item emotion scale
5
Description
Arousal level
Timepoint
Before and after reaching exhaustion in a submaximal endurance exercise under normobaric hypoxia conditions
Method of measurement
Using a 6-item scale of perceived arousal
6
Description
The degree of perception of pressure
Timepoint
Before and after reaching exhaustion in a submaximal endurance exercise under normobaric hypoxia conditions
Method of measurement
Using a pressure perception scale of 6 to 20 borg
Secondary outcomes
empty
Intervention groups
1
Description
Ginkgo biloba group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the Stroop test and reaction time in normal conditions and simulated altitude conditions and the submaximal aerobic test in simulated altitude conditions. . Subjects take ginkgo biloba for five days and take acetazolamide on the last day (the day before the test) and take the last dose of ginkgo biloba and acetazolamide on the day of the test. In other words, they consume ginkgo biloba for a period of five days. A one-week grace period will be considered.
Category
Treatment - Drugs
2
Description
placebo group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the Stroop test and reaction time in normal conditions and simulated altitude conditions and the submaximal aerobic test in simulated altitude conditions. Subjects take for five days and take acetazolamide on the last day (the day before the test) and take the last dose of placebo and acetazolamide on the day of the test. In other words, they consume placebo for a period of five days. A one-week grace period will be considered.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi University
Full name of responsible person
Sara Mansouri
Street address
Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
saramansourii1998@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Farzaneh Gandomi
Street address
Taq Bostan, University Street, Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
gandomif@razi.ac.ir
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
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
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
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