HealthyNCT04804657
Effects of Sage Extracts on Cognitive Function During Aerobic Exercise
A study testing Sage extracts Cognivia in people with Healthy, run by University of Burgundy at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sage extracts Cognivia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index lower than 27 and waist size lower than 94 cm
- physical activity higher than 3 hours a week
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Sage extracts Cognivia, Placebo
- Keywords
- cycling, cognition, sage, memory, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sage extracts CogniviaDietary supplement
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).
PlaceboDietary supplement
Made with maltodextrin. It will be administrated the the morning before the endurance test (oral administration).
| Study group | Role | What they receive |
|---|---|---|
| Sage extract | Active comparator | Two hours before the endurance test, participants were asked to absorb two capsules of sage extracts (600mg each - cognivia™) Receives: Dietary Supplement: Sage extracts Cognivia |
| placebo | Placebo comparator | Two hours before the endurance test, participants were asked to absorb two capsules of placebo (similar appearance than active comparator). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory
Changes in percent number of correct answers during a reverse digit immediate memory test
Measured: 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 outcomes (5)
Heart rate
Changes in heart rate using a polar belt (in beats per minutes)
Measured: 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
Rating of perceived exertion
Changes in rating of perceived exertion using a visual analogic scale (1-10)
Measured: 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
Reaction time
Changes in reaction time between a visual signal and manual action
Measured: 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
Stroop performance
Changes in percent number of correct answers during a stroop test
Measured: 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
Stroop reaction time
Changes in reaction time during the stroop test
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Feb 2021
- Primary completion28 Feb 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Babault, University of Burgundy
- Investigators
- Nicolas Babault, PhD, Principal investigator, University of Burgundy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804657
- Sponsor's protocol ID
- CEP2101
- Status last verified
- Mar 2021
- First submitted
- 26 Jan 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sage Extracts on Cognitive Function During Aerobic Exercise in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04804657
- Acronym / sponsor ID
- CEP2101
- Conditions
- Healthy
- Keywords
- cycling, cognition, sage, memory, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sage extract | Active comparator | Dietary Supplement: Sage extracts CogniviaTwo hours before the endurance test, participants were asked to absorb two capsules of sage extracts (600mg each - cognivia™) |
| placebo | Placebo comparator | Dietary Supplement: PlaceboTwo hours before the endurance test, participants were asked to absorb two capsules of placebo (similar appearance than active comparator). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index lower than 27 and waist size lower than 94 cm
- physical activity higher than 3 hours a week
- written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sage extracts CogniviaCognivia 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). | Dietary supplement | Sage extract |
| PlaceboMade with maltodextrin. It will be administrated the the morning before the endurance test (oral administration). | Dietary supplement | placebo |
Primary outcome
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
Changes in percent number of correct answers during a reverse digit immediate memory test
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Babault, PhD principal investigator
University of Burgundy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sage extracts Cognivia in people with Healthy, run by University of Burgundy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.