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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
      • Dijon, France, 21000
        • Centre d'Expertise de la Performance

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Sage extract
Two hours before the endurance test, participants were asked to absorb two capsules of sage extracts (600mg each - cognivia™)
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_COMPARATOR: placebo
Two hours before the endurance test, participants were asked to absorb two capsules of placebo (similar appearance than active comparator).
Dietary supplement: Placebo
Made with maltodextrin. It will be administrated the the morning before the endurance test (oral administration).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Burgundy

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEP2101

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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