Protocol summary
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Study aim
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Investigating the effects of ginkgo biloba on exercise and cognitive performance in hypoxic conditions after taking acetazolamide
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Design
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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.
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Settings and conduct
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Hypoxia through a hypoxia device.
Place: Razi University Faculty of Sports Sciences laboratory.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Ginkgo biloba group: The group that will consume ginkgo biloba.
Control group: the group that will take a placebo.
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Main outcome variables
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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
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Reason for update
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Typing error, the name of the drug was given incorrectly in the intervention groups section of the placebo.
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Acronym
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IRCT registration information
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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
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Registration date
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2023-07-20, 1402/04/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-03-05, 1401/12/14
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Expected recruitment end date
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2023-04-18, 1402/01/29
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Actual recruitment start date
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2023-04-24, 1402/02/04
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Actual recruitment end date
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2023-05-28, 1402/03/07
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Trial completion date
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2023-06-19, 1402/03/29
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Scientific title
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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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Public title
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The effects of Ginkgo biloba on exercise and cognitive performance in hypoxic conditions after taking acetazolamide
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old to 44 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
12
Actual sample size reached:
12
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-01, 1401/12/10
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Ethics committee reference number
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IR.RAZI.REC.1402.014
Health conditions studied
1
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Description of health condition studied
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The participants are healthy and trained male mountaineer.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Change in the time to reach exhaustion in a submaximal endurance exercise under hypoxic conditions
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Timepoint
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After administration of ginkgo biloba or placebo under hypoxic conditions
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Method of measurement
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Record time using a stopwatch
2
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Description
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Selective visual reaction time
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Timepoint
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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
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Method of measurement
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Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA)
3
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Description
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Cognitive function
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Timepoint
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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
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Method of measurement
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Using the color-word Stroop test
4
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Description
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sense of pleasure
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Timepoint
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Before and after reaching exhaustion in a submaximal endurance exercise under normobaric hypoxia conditions
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Method of measurement
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Using an 11-item emotion scale
5
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Description
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Arousal level
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Timepoint
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Before and after reaching exhaustion in a submaximal endurance exercise under normobaric hypoxia conditions
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Method of measurement
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Using a 6-item scale of perceived arousal
6
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Description
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The degree of perception of pressure
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Timepoint
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Before and after reaching exhaustion in a submaximal endurance exercise under normobaric hypoxia conditions
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Method of measurement
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Using a pressure perception scale of 6 to 20 borg
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Razi University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information.
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Total data
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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For meta-analysis research
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From where data/document is obtainable
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Vahid Tadibi
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What processes are involved for a request to access data/document
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A maximum of one month after the request
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Comments
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