Carbohydrate IngestionNCT04084808
Maple Products and Cognitive Performance During High Intensity Intermittent Exercise (HIIE)
A study testing Solution ingestion, Cognitive flexibility and Brain oxygenation in people with Carbohydrate Ingestion and Cognitive Performance, run by Université de Montréal at 1 site in Canada.
Trial summary
The purpose of this study is to compare the cognitive performance following the ingestion of carbohydrate solutions containing either maple syrup, maple sap, corn syrup, a commercial sport drink or water. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carbohydrate Ingestion, Cognitive Performance, High Intensity Interval Training
- What is being tested?
- Solution ingestion, Cognitive flexibility and Brain oxygenation
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteCanada
- Study dates
- 8 Aug 2017to 30 Mar 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Low alcohol consumption (<3 drinks/week)
- Not regularly taking medication for a known pathology
- Regularly practices endurance sports (cycling, running, etc.)
Who cannot join
- Intolerant to glucose (according to World Health Organization standards)
- Musculoskeletal injury or illness affecting exercise performance
- Failure to respect protocol guidelines (diet, exercise prior to experimentation, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ingestion of Maple Products During High Intensity Intermittent Exercise : Effects on Cognitive Flexibility
The purpose of this study is to compare the cognitive performance following the ingestion of carbohydrate solutions containing either maple syrup, maple sap, corn syrup, a commercial sport drink or water.
Read the detailed description
The study will require 4 meetings for each subject: a 30-minute meeting to explain the project; a meeting of 2 hours (glucose tolerance test, at rest); a one-hour meeting (maximum oxygen consumption test (VO2max) during an exercise conducted on an electromagnetically braked cycle ergometer, and a meeting of about 1,5 hours for experimentation (warmup, and 6 X 3-minutes intermittent efforts at 95% of MAP on a stationary bicycle with ingestion of a solution carbohydrates or sweetened water).
Visit #1 - Pre-participation (screening visit) Following an initial contact by phone or email, the subject will be invited to individual meetings which will last about 15 minutes. During the meeting, one of the project managers will check the eligibility of the potential subject in the study and, if eligible, will present him the details of the protocol specifying the discomforts and risks involved. The participant will be required to fill a Physical Activity Readiness Questionnaire (PAR-Q) and will be given a copy of the consent form. We will request the name and contact details of a person to contact in case of emergency, this information will be recorded and preserved in the subject matter. A period of at least three days will be allocated to make the decision whether to participate in the study or not. If the participant decides to participate in the study, he will be invited for the second visit (oral glucose tolerance test) and on this occasion will sign the consent form.
Visit #2 - Oral glucose tolerance test (OGTT) This test will be performed at Exercise Physiology Laboratory at the Department of kinesiology from the University of Montreal under the procedure commonly used for these tests. This procedure requires the ingestion of 300 mL of water containing 75 g of glucose in the morning (around 8am) after 12 hours of fasting, and blood samples and on the tip of a finger at 0, 60 and 120 minutes for the measurement of blood glucose. Subjects with higher blood glucose than 5 mmol/L before ingestion of glucose and greater than 8 mmol/L after ingestion (60 or 120 min) will not be considered for the study. These glucose tolerance standards are more stringent than those of the World Health Organization, because the objective of this test is not a diagnosis on glucose tolerance or a prognosis of its future development, but just n include in the study subjects who have good glucose tolerance.
Visit #3 - Maximum oxygen uptake testing: cycling VO2max This test will be conducted in the Exercise Physiology Laboratory at the Department of kinesiology from the University of Montreal. Exercise involves pedaling a stationary bike at a power output (resistance) gradually increasing until reaching VO2max. During the execution of the test, the subject is wearing surface electrodes to measure heart rate, a mouthpiece and nose clip to measure the volume of expired gas as well as the oxygen and carbon dioxide content to determine the consumption oxygen and carbon dioxide production. This type of testing is routinely used in our laboratory. The test can be stopped at any time by the will of the subject. For this test, guidelines established by the Exercise Physiology Laboratory at the Department of kinesiology from the University of Montreal will be followed. These guidelines are based on recommendations of ethics and safety of the "American College of Sports Medicine".
Visit #4 - Experimentation: The tests will be conducted at the Exercise Physiology Laboratory at the Department of kinesiology from the University of Montreal. The exercise is carried out on stationary cycle ergometer. Prior to exercise, electrodes (EMG) will be installed on the subject's hands, optodes helmet (NIRS) will be installed on the subject's head, and a first dose (167 mL) of a solution of carbohydrates, (120 g, 6% carbohydrate by volume), sweetened or unsweetened water will be administrated to the subject. During exercise protocol, the following solutions will be administered to the subject in a balanced, randomized, double-blind model: maple sap, maple syrup, glucose, a commercial sports drink and water. He will then begin a standardized warmup consisting of 10 minutes cycling at 40% of MAP followed by 6 bouts of 10 seconds at 95% of MAP separated by 50 seconds of passive recovery. After the second dose of solution (167 mL), the subject will have to do 6 efforts of 3 minutes at 95% of MAP, each bout separated by 3 minutes of passive recovery. He will be administered an additional dose after the first 4 efforts (4 X 167 mL). After the last effort, one last dose (167 mL) will be administered, and the subject will be asked to stay in the laboratory for the 45 minutes following the last effort. Cognitive task as well as blood sugar level will be evaluated before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise. Heart rate, brain oxidation and muscle electrical activity will be measured continuously during recovery. The total duration of this visit is approximately 90 minutes.
- Being tested
- Solution ingestion, Cognitive flexibility, Brain oxygenation, Palatability, Blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution ingestionDietary supplement
Subjects will be required to ingest 1 liter of the experimental solution, spread over the 45 minutes of exercise. A first ingestion of 167 mL of solution will be made at rest, right before starting warmup, and another dose (167 mL) after it. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort.
Cognitive flexibilityBehavioural
Subjects will be required to undergo the Stroop task. They will have to answer as quickly as possible, with push buttons, to a colour stimulus, following specific rules, and get the highest possible number of right answers. The flexibility block will show a pre-signal on a screen in front of the subject (a square or a cross will be shown). The form presented will indicate if the subject must use the colour of the writing, or the word written. Each block will consist of 50 trials, 25% of which switching the condition of answer. During this test, reaction time in milliseconds (ms) as well as the number of right answers will be measured.
This test will be measured before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.
Brain oxygenationProcedure or surgery
Optic imagery (Near-infrared spectroscopy, or NIRS) is a non-invasive technique allowing a fine investigation of the inner workings of the brain. It allows discrimination of oxygenated hemoglobin from deoxygenated hemoglobin, which informs on the coupling between blood flow and oxygen consumption inside the brain. To measure brain oxygenation with NIRS, optodes will be installed on the subject's skin without glue or transmission gel.
[ Time Frame: During Stroop's task (i.e.before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise). ] Measured with near-infrared spectroscopy (NIRS).
PalatabilityOther
Subjects will be asked to fill out a short form on the palatability of the solution ingestion, after ingesting the first solution and at the end of exercise, after ingestion the last solution.
Blood glucoseProcedure or surgery
Blood glucose will be measured with a puncture on the tip of a finger to get a droplet of blood.
Perceived exertionBehavioural
Perceived exertion will be assessed using 3 scales : Borg (RPE), and DP-15 scale for mental effort (Delignières, Brisswalter, \& Legros, 1994). These scales will be administrated at the end of each 3 minute high intensity bout.
High Intensity Interval Training boutsBehavioural
6 3-minute bouts at 95% of maximal aerobic power will be done on a bike. Each bout will be separated by 3 minutes of passive recovery. The last bout will be followed by 45 minutes of rest.
| Study group | Role | What they receive |
|---|---|---|
| Maple Syrup | Experimental | A maple syrup solution of 6% carbohydrate per volume labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. Receives: Dietary Supplement: Solution ingestion; Behavioral: Cognitive flexibility; Procedure: Brain oxygenation; Other: Palatability; Procedure: Blood glucose; Behavioral: Perceived exertion; Behavioral: High Intensity Interval Training bouts |
| Maple sap | Experimental | A maple sap solution of 6% carbohydrate per volume labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. Receives: Dietary Supplement: Solution ingestion; Behavioral: Cognitive flexibility; Procedure: Brain oxygenation; Other: Palatability; Procedure: Blood glucose; Behavioral: Perceived exertion; Behavioral: High Intensity Interval Training bouts |
| Glucose | Active comparator | A glucose solution of 6% carbohydrate per volume labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. Receives: Dietary Supplement: Solution ingestion; Behavioral: Cognitive flexibility; Procedure: Brain oxygenation; Other: Palatability; Procedure: Blood glucose; Behavioral: Perceived exertion; Behavioral: High Intensity Interval Training bouts |
| Sports drink | Active comparator | A commercial sports drink of 6% carbohydrate per volume labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. Receives: Dietary Supplement: Solution ingestion; Behavioral: Cognitive flexibility; Procedure: Brain oxygenation; Other: Palatability; Procedure: Blood glucose; Behavioral: Perceived exertion; Behavioral: High Intensity Interval Training bouts |
| Water | Placebo comparator | A solution containing stevia (sugar substitute) labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. Receives: Dietary Supplement: Solution ingestion; Behavioral: Cognitive flexibility; Procedure: Brain oxygenation; Other: Palatability; Procedure: Blood glucose; Behavioral: Perceived exertion; Behavioral: High Intensity Interval Training bouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive flexibility
Measured with a computerized version of the 4th board of Stroop's Task.
Measured: Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.
Change in Mental Effort
Measured with the DP-15 Scale, ranging from 1 to 15, 1 corresponds to "very, very easy" and 15 is "very, very hard"
Measured: Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.
Change in Perceived exertion
Measured using a Category Ratio scale on 10 points (CR10), 0 signifies no exertion and 10 being maximal effort.
Measured: Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.
Change in Brain oxygenation
Measured with near-infrared spectroscopy (NIRS).
Measured: During Stroop's task (i.e.before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise).
Secondary outcomes (1)
Change in Blood glucose concentration
Measured by a puncture on the tip of the finger to collect a droplet of blood and process it with a commercial glucometer.
Measured: Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start8 Aug 2017
- Primary completion22 Dec 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbohydrate IngestionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération des producteurs acéricoles du Québec
- Responsible party
- Sponsor
- Investigators
- Jonathan Tremblay, Principal investigator, Associate ProfessorOlivier Dupuy, Ph.D., Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084808
- Sponsor's protocol ID
- Maple-cognition-exercise
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ingestion of Maple Products During High Intensity Intermittent Exercise : Effects on Cognitive Flexibility
- ClinicalTrials.gov ID
- NCT04084808
- Acronym / sponsor ID
- Maple-cognition-exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Fédération des producteurs acéricoles du Québec
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 10 Sep 2019 (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.
The purpose of this study is to compare the cognitive performance following the ingestion of carbohydrate solutions containing either maple syrup, maple sap, corn syrup, a commercial sport drink or water.
Detailed description
The study will require 4 meetings for each subject: a 30-minute meeting to explain the project; a meeting of 2 hours (glucose tolerance test, at rest); a one-hour meeting (maximum oxygen consumption test (VO2max) during an exercise conducted on an electromagnetically braked cycle ergometer, and a meeting of about 1,5 hours for experimentation (warmup, and 6 X 3-minutes intermittent efforts at 95% of MAP on a stationary bicycle with ingestion of a solution carbohydrates or sweetened water).
Visit #1 - Pre-participation (screening visit) Following an initial contact by phone or email, the subject will be invited to individual meetings which will last about 15 minutes. During the meeting, one of the project managers will check the eligibility of the potential subject in the study and, if eligible, will present him the details of the protocol specifying the discomforts and risks involved. The participant will be required to fill a Physical Activity Readiness Questionnaire (PAR-Q) and will be given a copy of the consent form. We will request the name and contact details of a person to contact in case of emergency, this information will be recorded and preserved in the subject matter. A period of at least three days will be allocated to make the decision whether to participate in the study or not. If the participant decides to participate in the study, he will be invited for the second visit (oral glucose tolerance test) and on this occasion will sign the consent form.
Visit #2 - Oral glucose tolerance test (OGTT) This test will be performed at Exercise Physiology Laboratory at the Department of kinesiology from the University of Montreal under the procedure commonly used for these tests. This procedure requires the ingestion of 300 mL of water containing 75 g of glucose in the morning (around 8am) after 12 hours of fasting, and blood samples and on the tip of a finger at 0, 60 and 120 minutes for the measurement of blood glucose. Subjects with higher blood glucose than 5 mmol/L before ingestion of glucose and greater than 8 mmol/L after ingestion (60 or 120 min) will not be considered for the study. These glucose tolerance standards are more stringent than those of the World Health Organization, because the objective of this test is not a diagnosis on glucose tolerance or a prognosis of its future development, but just n include in the study subjects who have good glucose tolerance.
Visit #3 - Maximum oxygen uptake testing: cycling VO2max This test will be conducted in the Exercise Physiology Laboratory at the Department of kinesiology from the University of Montreal. Exercise involves pedaling a stationary bike at a power output (resistance) gradually increasing until reaching VO2max. During the execution of the test, the subject is wearing surface electrodes to measure heart rate, a mouthpiece and nose clip to measure the volume of expired gas as well as the oxygen and carbon dioxide content to determine the consumption oxygen and carbon dioxide production. This type of testing is routinely used in our laboratory. The test can be stopped at any time by the will of the subject. For this test, guidelines established by the Exercise Physiology Laboratory at the Department of kinesiology from the University of Montreal will be followed. These guidelines are based on recommendations of ethics and safety of the "American College of Sports Medicine".
Visit #4 - Experimentation: The tests will be conducted at the Exercise Physiology Laboratory at the Department of kinesiology from the University of Montreal. The exercise is carried out on stationary cycle ergometer. Prior to exercise, electrodes (EMG) will be installed on the subject's hands, optodes helmet (NIRS) will be installed on the subject's head, and a first dose (167 mL) of a solution of carbohydrates, (120 g, 6% carbohydrate by volume), sweetened or unsweetened water will be administrated to the subject. During exercise protocol, the following solutions will be administered to the subject in a balanced, randomized, double-blind model: maple sap, maple syrup, glucose, a commercial sports drink and water. He will then begin a standardized warmup consisting of 10 minutes cycling at 40% of MAP followed by 6 bouts of 10 seconds at 95% of MAP separated by 50 seconds of passive recovery. After the second dose of solution (167 mL), the subject will have to do 6 efforts of 3 minutes at 95% of MAP, each bout separated by 3 minutes of passive recovery. He will be administered an additional dose after the first 4 efforts (4 X 167 mL). After the last effort, one last dose (167 mL) will be administered, and the subject will be asked to stay in the laboratory for the 45 minutes following the last effort. Cognitive task as well as blood sugar level will be evaluated before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise. Heart rate, brain oxidation and muscle electrical activity will be measured continuously during recovery. The total duration of this visit is approximately 90 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Maple Syrup | Experimental | Dietary Supplement: Solution ingestion, Behavioral: Cognitive flexibility, Procedure: Brain oxygenation, Other: Palatability, Procedure: Blood glucose, Behavioral: Perceived exertion, Behavioral: High Intensity Interval Training boutsA maple syrup solution of 6% carbohydrate per volume labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. |
| Maple sap | Experimental | Dietary Supplement: Solution ingestion, Behavioral: Cognitive flexibility, Procedure: Brain oxygenation, Other: Palatability, Procedure: Blood glucose, Behavioral: Perceived exertion, Behavioral: High Intensity Interval Training boutsA maple sap solution of 6% carbohydrate per volume labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. |
| Glucose | Active comparator | Dietary Supplement: Solution ingestion, Behavioral: Cognitive flexibility, Procedure: Brain oxygenation, Other: Palatability, Procedure: Blood glucose, Behavioral: Perceived exertion, Behavioral: High Intensity Interval Training boutsA glucose solution of 6% carbohydrate per volume labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. |
| Sports drink | Active comparator | Dietary Supplement: Solution ingestion, Behavioral: Cognitive flexibility, Procedure: Brain oxygenation, Other: Palatability, Procedure: Blood glucose, Behavioral: Perceived exertion, Behavioral: High Intensity Interval Training boutsA commercial sports drink of 6% carbohydrate per volume labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. |
| Water | Placebo comparator | Dietary Supplement: Solution ingestion, Behavioral: Cognitive flexibility, Procedure: Brain oxygenation, Other: Palatability, Procedure: Blood glucose, Behavioral: Perceived exertion, Behavioral: High Intensity Interval Training boutsA solution containing stevia (sugar substitute) labeled with 13C-sucrose will first be ingested at rest (167 mL), right before starting warmup. Another dose (167 mL) will be administered after warmup. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Low alcohol consumption (<3 drinks/week)
- Not regularly taking medication for a known pathology
- Regularly practices endurance sports (cycling, running, etc.)
Key exclusion criteria (3 listed)
- Intolerant to glucose (according to World Health Organization standards)
- Musculoskeletal injury or illness affecting exercise performance
- Failure to respect protocol guidelines (diet, exercise prior to experimentation, etc.)
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 |
|---|---|---|
| Solution ingestionSubjects will be required to ingest 1 liter of the experimental solution, spread over the 45 minutes of exercise. A first ingestion of 167 mL of solution will be made at rest, right before starting warmup, and another dose (167 mL) after it. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort. | Dietary supplement | Glucose, Maple Syrup, Maple sap, Sports drink, Water |
| Cognitive flexibilitySubjects will be required to undergo the Stroop task. They will have to answer as quickly as possible, with push buttons, to a colour stimulus, following specific rules, and get the highest possible number of right answers. The flexibility block will show a pre-signal on a screen in front of the subject (a square or a cross will be shown). The form presented will indicate if the subject must use the colour of the writing, or the word written. Each block will consist of 50 trials, 25% of which switching the condition of answer. During this test, reaction time in milliseconds (ms) as well as the number of right answers will be measured. This test will be measured before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise. | Behavioural | Glucose, Maple Syrup, Maple sap, Sports drink, Water |
| Brain oxygenationOptic imagery (Near-infrared spectroscopy, or NIRS) is a non-invasive technique allowing a fine investigation of the inner workings of the brain. It allows discrimination of oxygenated hemoglobin from deoxygenated hemoglobin, which informs on the coupling between blood flow and oxygen consumption inside the brain. To measure brain oxygenation with NIRS, optodes will be installed on the subject's skin without glue or transmission gel. [ Time Frame: During Stroop's task (i.e.before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise). ] Measured with near-infrared spectroscopy (NIRS). | Procedure or surgery | Glucose, Maple Syrup, Maple sap, Sports drink, Water |
| PalatabilitySubjects will be asked to fill out a short form on the palatability of the solution ingestion, after ingesting the first solution and at the end of exercise, after ingestion the last solution. | Other | Glucose, Maple Syrup, Maple sap, Sports drink, Water |
| Blood glucoseBlood glucose will be measured with a puncture on the tip of a finger to get a droplet of blood. | Procedure or surgery | Glucose, Maple Syrup, Maple sap, Sports drink, Water |
| Perceived exertionPerceived exertion will be assessed using 3 scales : Borg (RPE), and DP-15 scale for mental effort (Delignières, Brisswalter, \& Legros, 1994). These scales will be administrated at the end of each 3 minute high intensity bout. | Behavioural | Glucose, Maple Syrup, Maple sap, Sports drink, Water |
| High Intensity Interval Training bouts6 3-minute bouts at 95% of maximal aerobic power will be done on a bike. Each bout will be separated by 3 minutes of passive recovery. The last bout will be followed by 45 minutes of rest. | Behavioural | Glucose, Maple Syrup, Maple sap, Sports drink, Water |
Primary outcome
Change in Cognitive flexibility
Time frame: Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.
Measured with a computerized version of the 4th board of Stroop's Task.
Change in Mental Effort
Time frame: Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.
Measured with the DP-15 Scale, ranging from 1 to 15, 1 corresponds to "very, very easy" and 15 is "very, very hard"
Change in Perceived exertion
Time frame: Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.
Measured using a Category Ratio scale on 10 points (CR10), 0 signifies no exertion and 10 being maximal effort.
Change in Brain oxygenation
Time frame: During Stroop's task (i.e.before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise).
Measured with near-infrared spectroscopy (NIRS).
1 secondary outcome
Change in Blood glucose concentration
Time frame: Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.
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 10 Sep 2019.
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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.
Jonathan Tremblay principal investigator
Associate Professor
Olivier Dupuy, Ph.D. study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solution ingestion, Cognitive flexibility and Brain oxygenation in people with Carbohydrate Ingestion and Cognitive Performance, run by Université de Montréal at 1 site in Canada.
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 10 Sep 2019. 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 Canada. 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?
Change in Cognitive flexibility (time frame: Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.). The study lists 4 primary outcomes in all. 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 10 Sep 2019.