AzTrials
AzTrials

Carbohydrate IngestionNCT02880124

Maple Products and Exercise Performance

A study testing Solution ingestion, Constant load cycling and Expired gas sampling in people with Carbohydrate Ingestion and Fuel Selection, run by Université de Montréal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the acute metabolic responses and time-trial 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
What is being tested?
Solution ingestion, Constant load cycling and Expired gas sampling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteCanada
Study dates
11 Jul 2016to 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 WHO 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.

Canada1 site
  • Centre d'éducation physique et sportive de l'Université de Montréal (CEPSUM)

    Montreal, Quebec, H3C 3J7

Other trials in Canada

About this study

Official title: Ingestion of Maple Products During Exercise: Effects on Energy Metabolism and Time-trial Performance

The purpose of this study is to compare the acute metabolic responses and time-trial 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 4 hours for experimentation (120-min exercise on a stationary bicycle with ingestion of a solution carbohydrates or sweetened water, and a 20-km time trial).

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".

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. It lasts 120 minutes at a power output corresponding to 60% of the VO2max obtained during the maximal test. A volume of a carbohydrate solution (120 g, 6% carbohydrate by volume) or sweetened water will be administered to the subject before (571 mL) and during exercise (286 mL every 30 minutes). The following solutions will be administered in a balanced, randomized, double-blind model: maple sap, maple syrup, glucose, a commercial sports drink and water with a glucose trace (0.001% carbohydrate by volume). Under conditions where only a trace of water or glucose are administered, a natural sweetener (stevia) will be added to obtain a sweet taste similar to other conditions. Carbohydrate solutions will all be artificially enriched in 13C. The volume ingested after 30 minutes of exercise will be artificially enriched in deuterium (D2O, 8g incorporated in the ingestion of 286 mL).

Being tested
Solution ingestion, Constant load cycling, Expired gas sampling, Indirect respiratory calorimetry, Palatability
Keywords
Isotope Labeling, Stable, Exercise, Physical, Calorimetry, Indirect, Athletic Performance, Sugar Maple
Medical subject headings
Motor Activity

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 2 litres of the experimental solution, spread over the 2 hours of exercise. A first ingestion of 572 mL of solution will be made at rest, 30 minutes before starting exercise, and 286 mL will be ingested immediately before the start of exercise and every 30 minutes during the exercise period.

  • Constant load cyclingBehavioural

    Subjects will be required to perform 2 hours of cycling exercise at a power output eliciting 60% of VO2max.

  • Expired gas samplingProcedure or surgery

    Subjects will be asked, twice, to provide a forced expiration into a 10 mL plastic tube in order to collect a sample expired gases. This procedure will be done immediately before blood sampling and ingestion of the solution, every 30 minutes.

  • Indirect respiratory calorimetryProcedure or surgery

    A mouthpiece and nose plug will be placed on the subject and expired gases will be analyzed by a metabolic cart during 3 minutes. This procedure will be done immediately before expired gas collection, blood sampling and ingestion of the solution, every 30 minutes.

  • 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.

  • GastrointestinalOther

    At the end of the time trial, subjects will be asked to fill out a short form on gastrointestinal issues they might have had during experimentation.

  • Blood samplingProcedure or surgery

    A catheter will be inserted in an antecubital vein and a saline solution will be continuously perfused to maintain the vessel open. 15 mL of blood will be collected every 30 minutes, immediately before ingesting the solution.

  • Time trialBehavioural

    Subjects will be required to complete a simulated 20-km time trial on the cycle ergometer set in linear mode (where resistance is proportional to pedalling cadence), starting at 70% of the peak power output for the cadence spontaneously adopted by the subject during 2 hours of exercise.

Study groups in NCT02880124
Study groupRoleWhat they receive
Maple syrupExperimentalA maple syrup solution of 6% carbohydrate per volume labeled with 13C-sucrose will be ingested 30 min prior to starting exercise and every 30 min thereafter (solution ingestion), until 2h of the constant load cycling exercise is completed. Starting 4 min before each solution ingested over the protocol, indirect respiratory calorimetry, expired gas sampling, blood sampling will occur. After completing the 2h of exercise, subjects will be given a few minutes of rest (5-min) during which the catheter will be removed, after which the 20-km time trial will be initiated on the same ergometer. Palatability of the solution will be assessed after the first ingestion and after ingesting the last solution. Gastrointestinal symptoms will be assessed after the time trial.
Receives: Dietary Supplement: Solution ingestion; Behavioral: Constant load cycling; Procedure: Expired gas sampling; Procedure: Indirect respiratory calorimetry; Other: Palatability; Other: Gastrointestinal; Procedure: Blood sampling; Behavioral: Time trial
Maple sapExperimentalA maple sap solution of 6% carbohydrate per volume labeled with 13C-sucrose will be ingested 30 min prior to starting exercise and every 30 min thereafter (solution ingestion), until 2h of the constant load cycling exercise is completed. Starting 4 min before each solution ingested over the protocol, indirect respiratory calorimetry, expired gas sampling, blood sampling will occur. After completing the 2h of exercise, subjects will be given a few minutes of rest (5-min) during which the catheter will be removed, after which the 20-km time trial will be initiated on the same ergometer. Palatability of the solution will be assessed after the first ingestion and after ingesting the last solution. Gastrointestinal symptoms will be assessed after the time trial.
Receives: Dietary Supplement: Solution ingestion; Behavioral: Constant load cycling; Procedure: Expired gas sampling; Procedure: Indirect respiratory calorimetry; Other: Palatability; Other: Gastrointestinal; Procedure: Blood sampling; Behavioral: Time trial
GlucoseActive comparatorA glucose solution of 6% carbohydrate per volume labeled with 13C-sucrose will be ingested 30 min prior to starting exercise and every 30 min thereafter (solution ingestion), until 2h of the constant load cycling exercise is completed. Starting 4 min before each solution ingested over the protocol, indirect respiratory calorimetry, expired gas sampling, blood sampling will occur. After completing the 2h of exercise, subjects will be given a few minutes of rest (5-min) during which the catheter will be removed, after which the 20-km time trial will be initiated on the same ergometer. Palatability of the solution will be assessed after the first ingestion and after ingesting the last solution. Gastrointestinal symptoms will be assessed after the time trial.
Receives: Dietary Supplement: Solution ingestion; Behavioral: Constant load cycling; Procedure: Expired gas sampling; Procedure: Indirect respiratory calorimetry; Other: Palatability; Other: Gastrointestinal; Procedure: Blood sampling; Behavioral: Time trial
Sport drinkActive comparatorA Gatorade (TM) solution of 6% carbohydrate per volume labeled with 13C-sucrose will be ingested 30 min prior to starting exercise and every 30 min thereafter (solution ingestion), until 2h of the constant load cycling exercise is completed. Starting 4 min before each solution ingested over the protocol, indirect respiratory calorimetry, expired gas sampling, blood sampling will occur. After completing the 2h of exercise, subjects will be given a few minutes of rest (5-min) during which the catheter will be removed, after which the 20-km time trial will be initiated on the same ergometer. Palatability of the solution will be assessed after the first ingestion and after ingesting the last solution. Gastrointestinal symptoms will be assessed after the time trial.
Receives: Dietary Supplement: Solution ingestion; Behavioral: Constant load cycling; Procedure: Expired gas sampling; Procedure: Indirect respiratory calorimetry; Other: Palatability; Other: Gastrointestinal; Procedure: Blood sampling; Behavioral: Time trial
TracePlacebo comparatorA solution containing stevia (sugar substitute) and trace amounts of glucose (3g) labeled with 13C-sucrose will be ingested 30 min prior to starting exercise and every 30 min thereafter (solution ingestion), until 2h of the constant load cycling exercise is completed. Starting 4 min before each solution ingested over the protocol, indirect respiratory calorimetry, expired gas sampling, blood sampling will occur. After completing the 2h of exercise, subjects will be given a few minutes of rest (5-min) during which the catheter will be removed, after which the 20-km time trial will be initiated on the same ergometer. Palatability of the solution will be assessed after the first ingestion and after ingesting the last solution. Gastrointestinal symptoms will be assessed after the time trial.
Receives: Dietary Supplement: Solution ingestion; Behavioral: Constant load cycling; Procedure: Expired gas sampling; Procedure: Indirect respiratory calorimetry; Other: Palatability; Other: Gastrointestinal; Procedure: Blood sampling; Behavioral: Time trial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exogenous carbohydrate oxidation

    Measured by indirect respiratory calorimetry combined with tracer techniques.

    Measured: Every 30 minutes during the exercise protocol, during 3 minutes of expired gas collection.

  2. Exercise performance in the 20-km time trial

    Duration to complete distance and mean power sustained during the performance

    Measured: At the end of 2 hours of exercise

Secondary outcomes (7)
  1. Blood insulin concentration

    Blood is sampled using a venous catheter over about 60 seconds. Following centrifugation to extract the plasma, a small sample is used to measure insulin concentration.

    Measured: Every 30 minutes during the exercise protocol

  2. Blood glucose concentration

    Blood is sampled using a venous catheter over about 60 seconds. Following centrifugation to extract the plasma, a small sample is used to measure glucose concentration.

    Measured: Every 30 minutes during the exercise protocol

  3. Blood free fatty acid concentration

    Blood is sampled using a venous catheter over about 60 seconds. Following centrifugation to extract the plasma, a small sample is used to measure free fatty acid concentration.

    Measured: Every 30 minutes during the exercise protocol

  4. Blood lactate concentration

    Blood is sampled using a venous catheter over about 60 seconds. Following centrifugation to extract the plasma, a small sample is used to measure lactate concentration.

    Measured: Every 30 minutes during the exercise protocol

  5. Muscle glycogen oxidation

    Measured by indirect respiratory calorimetry combined with tracer techniques.

    Measured: Every 30 minutes during the exercise protocol, during 3 minutes of expired gas collection.

  6. Oxidation of glucose released by the liver

    Measured by indirect respiratory calorimetry combined with tracer techniques. Average of 3 minutes of steady-state expired gas collection.

    Measured: Every 30 minutes during the exercise protocol, during 3 minutes of expired gas collection.

  7. Total carbohydrate oxidation

    Measured by indirect respiratory calorimetry.

    Measured: Every 30 minutes during the exercise protocol, during 3 minutes of expired gas collection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2016 (estimated)
  2. Study start11 Jul 2016
  3. Primary completion22 Dec 2017
  4. Study completion30 Mar 2018

Resources

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
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02880124
Sponsor's protocol ID
16-088-CERES-P
Status last verified
Aug 2019
First submitted
30 Jul 2016
Last updated
21 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Lavoie L, Tremblay J. Ingestion of maple-based and other carbohydrate sports drinks: effect on sensory perceptions during prolonged exercise. J Int Soc Sports Nutr. 2020 Dec 9;17(1):63. doi: 10.1186/s12970-020-00384-3.

    PubMed 33298104

Questions about this trial

What is this clinical trial studying?

A study testing Solution ingestion, Constant load cycling and Expired gas sampling in people with Carbohydrate Ingestion and Fuel Selection, 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 21 Aug 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?

Exogenous carbohydrate oxidation (time frame: Every 30 minutes during the exercise protocol, during 3 minutes of expired gas collection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02880124, which also lists 1 linked publication.

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 21 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in