NCT04084808

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 8, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
Last Updated

September 10, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

August 20, 2019

Last Update Submit

September 9, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Cognitive flexibility

    Measured with a computerized version of the 4th board of Stroop's Task.

    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"

    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.

    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).

    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

    Baseline (Before the exercise protocol), during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise.

Study Arms (5)

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.

Dietary Supplement: Solution ingestionBehavioral: Cognitive flexibilityProcedure: Brain oxygenationOther: PalatabilityProcedure: Blood glucoseBehavioral: Perceived exertionBehavioral: 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.

Dietary Supplement: Solution ingestionBehavioral: Cognitive flexibilityProcedure: Brain oxygenationOther: PalatabilityProcedure: Blood glucoseBehavioral: Perceived exertionBehavioral: 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.

Dietary Supplement: Solution ingestionBehavioral: Cognitive flexibilityProcedure: Brain oxygenationOther: PalatabilityProcedure: Blood glucoseBehavioral: Perceived exertionBehavioral: 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.

Dietary Supplement: Solution ingestionBehavioral: Cognitive flexibilityProcedure: Brain oxygenationOther: PalatabilityProcedure: Blood glucoseBehavioral: Perceived exertionBehavioral: 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.

Dietary Supplement: Solution ingestionBehavioral: Cognitive flexibilityProcedure: Brain oxygenationOther: PalatabilityProcedure: Blood glucoseBehavioral: Perceived exertionBehavioral: High Intensity Interval Training bouts

Interventions

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.

GlucoseMaple SyrupMaple sapSports drinkWater

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.

GlucoseMaple SyrupMaple sapSports drinkWater

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).

GlucoseMaple SyrupMaple sapSports drinkWater

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.

GlucoseMaple SyrupMaple sapSports drinkWater
Blood glucosePROCEDURE

Blood glucose will be measured with a puncture on the tip of a finger to get a droplet of blood.

GlucoseMaple SyrupMaple sapSports drinkWater

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.

GlucoseMaple SyrupMaple sapSports drinkWater

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.

GlucoseMaple SyrupMaple sapSports drinkWater

Eligibility Criteria

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

You may qualify if:

  • Low alcohol consumption (\<3 drinks/week)
  • Not regularly taking medication for a known pathology
  • Regularly practices endurance sports (cycling, running, etc.)

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

Blood Glucose

Intervention Hierarchy (Ancestors)

GlucoseHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Jonathan Tremblay

    Associate Professor

    PRINCIPAL INVESTIGATOR
  • Olivier Dupuy, Ph.D.

    Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

September 10, 2019

Study Start

August 8, 2017

Primary Completion

December 22, 2017

Study Completion

March 30, 2018

Last Updated

September 10, 2019

Record last verified: 2019-08

Locations