NCT04804657

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

27 days

First QC Date

January 26, 2021

Last Update Submit

March 17, 2021

Conditions

Healthy

Keywords

cyclingcognitionsagememoryfatigue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Heart rate

    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

    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

    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

    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

    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

Study Arms (2)

Sage extract

ACTIVE COMPARATOR

Two hours before the endurance test, participants were asked to absorb two capsules of sage extracts (600mg each - cognivia™)

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).

Dietary Supplement: Placebo

Interventions

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).

Sage extract
PlaceboDIETARY_SUPPLEMENT

Made with maltodextrin. It will be administrated the the morning before the endurance test (oral administration).

placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index lower than 27 and waist size lower than 94 cm
  • physical activity higher than 3 hours a week
  • written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Expertise de la Performance

Dijon, 21000, France

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Babault, PhD

    University of Burgundy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 26, 2021

First Posted

March 18, 2021

Study Start

February 1, 2021

Primary Completion

February 28, 2021

Study Completion

March 15, 2021

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)