- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04804657
Effects of Sage Extracts on Cognitive Function During Aerobic Exercise
March 17, 2021 updated by: Nicolas Babault, University of Burgundy
Effects of Sage Extracts on Cognitive Function During Aerobic Exercise in Healthy Individuals
Extracts of sage have been reported to interact with central nervous system (CNS) mechanisms relevant to cognitive performance but, to date, no trial has clearly demonstrated the possible effects in healthy individuals in fatiguing conditions.
The current study investigates the effects of this supplementation in healthy males and females versus placebo on cognition, heart rate and perceived exertion, during a fatiguing cycling exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Healthy males and females will be tested in fresh and fatiguing conditions to mimic individuals at the beginning or during a competition where cognitive function are important for decision making for example.
Tests will be conducted during the warm-up (fresh), during fatiguing situations (during two consecutive 10-minutes pedaling exercises) and during recovery.
Tests will include a reverse digit memory test (from 3 to 7 digits), a stroop test, a simple reaction time test.
Moreover, heart rate and rating of perceived exertion will be quantified.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dijon, France, 21000
- Centre d'Expertise de la Performance
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index lower than 27 and waist size lower than 94 cm
- physical activity higher than 3 hours a week
- written informed consent
Exclusion Criteria:
- more than 12 hours training a week
- asthmatic, smokers or under medicinal drugs
- dietary supplement, sports drink, special dietary food or functional food, of any kind, liable or presented as liable to enhance physical performances
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Sage extract
Two hours before the endurance test, participants were asked to absorb two capsules of sage extracts (600mg each - cognivia™)
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Cognivia is composed of 400 mg of aqueous extract from Salvia officinalis and the remaining 200 mg contained 50 µL of Salvia lavandulaefolia essential oil and encapsulated with gum acacia.
It will be administrated the the morning before the endurance test (oral administration).
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PLACEBO_COMPARATOR: placebo
Two hours before the endurance test, participants were asked to absorb two capsules of placebo (similar appearance than active comparator).
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Made with maltodextrin.
It will be administrated the the morning before the endurance test (oral administration).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memory
Time Frame: During the 10-minutes warm-up, immediately after the first 10-minutes fatiguing exercise, after the second 10-minutes fatiguing exercise and after a five minutes recovery period
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Changes in percent number of correct answers during a reverse digit immediate memory test
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During the 10-minutes warm-up, immediately after the first 10-minutes fatiguing exercise, after the second 10-minutes fatiguing exercise and after a five minutes recovery period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: At rest, at the end of the 10-minutes warm-up, at the end of the first 10-minutes fatiguing exercise, at the end of the second 10-minutes fatiguing exercise, after 5 minutes of recovery
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Changes in heart rate using a polar belt (in beats per minutes)
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At rest, at the end of the 10-minutes warm-up, at the end of the first 10-minutes fatiguing exercise, at the end of the second 10-minutes fatiguing exercise, after 5 minutes of recovery
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Rating of perceived exertion
Time Frame: At rest, at the end of the 10-minutes warm-up, at the end of the first 10-minutes fatiguing exercise, at the end of the second 10-minutes fatiguing exercise, after 5 minutes of recovery
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Changes in rating of perceived exertion using a visual analogic scale (1-10)
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At rest, at the end of the 10-minutes warm-up, at the end of the first 10-minutes fatiguing exercise, at the end of the second 10-minutes fatiguing exercise, after 5 minutes of recovery
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Reaction time
Time Frame: During the 10-minutes warm-up, immediately after the first 10-minutes fatiguing exercise, after the second 10-minutes fatiguing exercise and after a five minutes recovery period
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Changes in reaction time between a visual signal and manual action
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During the 10-minutes warm-up, immediately after the first 10-minutes fatiguing exercise, after the second 10-minutes fatiguing exercise and after a five minutes recovery period
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Stroop performance
Time Frame: During the 10-minutes warm-up, immediately after the first 10-minutes fatiguing exercise, after the second 10-minutes fatiguing exercise and after a five minutes recovery period
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Changes in percent number of correct answers during a stroop test
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During the 10-minutes warm-up, immediately after the first 10-minutes fatiguing exercise, after the second 10-minutes fatiguing exercise and after a five minutes recovery period
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Stroop reaction time
Time Frame: During the 10-minutes warm-up, immediately after the first 10-minutes fatiguing exercise, after the second 10-minutes fatiguing exercise and after a five minutes recovery period
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Changes in reaction time during the stroop test
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During the 10-minutes warm-up, immediately after the first 10-minutes fatiguing exercise, after the second 10-minutes fatiguing exercise and after a five minutes recovery period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2021
Primary Completion (ACTUAL)
February 28, 2021
Study Completion (ACTUAL)
March 15, 2021
Study Registration Dates
First Submitted
January 26, 2021
First Submitted That Met QC Criteria
March 17, 2021
First Posted (ACTUAL)
March 18, 2021
Study Record Updates
Last Update Posted (ACTUAL)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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