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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04804657
Other study ID # CEP2101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date March 15, 2021

Study information

Verified date March 2021
Source University of Burgundy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date March 15, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Sage extracts Cognivia
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).
Placebo
Made with maltodextrin. It will be administrated the the morning before the endurance test (oral administration).

Locations

Country Name City State
France Centre d'Expertise de la Performance Dijon

Sponsors (1)

Lead Sponsor Collaborator
University of Burgundy

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Memory Changes in percent number of correct answers during a reverse digit immediate memory test 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
Secondary Heart rate Changes in heart rate using a polar belt (in beats per minutes) 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
Secondary Rating of perceived exertion Changes in rating of perceived exertion using a visual analogic scale (1-10) 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
Secondary Reaction time Changes in reaction time between a visual signal and manual action 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
Secondary Stroop performance Changes in percent number of correct answers during a stroop test 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
Secondary Stroop reaction time Changes in reaction time during the stroop test 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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