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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02880124
Other study ID # 16-088-CERES-P
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 11, 2016
Est. completion date March 30, 2018

Study information

Verified date August 2019
Source Université de Montréal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date March 30, 2018
Est. primary completion date December 22, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Low alcohol consumption (<3 drinks/week)

- Not regularly taking medication for a known pathology

- Regularly practices endurance sports (cycling, running, etc.)

Exclusion Criteria:

- 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.)

Study Design


Intervention

Dietary Supplement:
Solution ingestion
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.
Behavioral:
Constant load cycling
Subjects will be required to perform 2 hours of cycling exercise at a power output eliciting 60% of VO2max.
Procedure:
Expired gas sampling
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 calorimetry
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.
Other:
Palatability
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.
Gastrointestinal
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.
Procedure:
Blood sampling
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.
Behavioral:
Time trial
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.

Locations

Country Name City State
Canada Centre d'éducation physique et sportive de l'Université de Montréal (CEPSUM) Montréal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Université de Montréal Fédération des producteurs acéricoles du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Palatability score Score computed from ratings on a visual analog scale. Within 5 minutes after the first ingestion and within 5 minutes after the last ingestion.
Other Score of gastrointestinal symptoms Score computed from ratings on a visual analog scale. Within 5 minutes after the end of exercise
Primary Exogenous carbohydrate oxidation Measured by indirect respiratory calorimetry combined with tracer techniques. Every 30 minutes during the exercise protocol, during 3 minutes of expired gas collection.
Primary Exercise performance in the 20-km time trial Duration to complete distance and mean power sustained during the performance At the end of 2 hours of exercise
Secondary 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. Every 30 minutes during the exercise protocol
Secondary 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. Every 30 minutes during the exercise protocol
Secondary 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. Every 30 minutes during the exercise protocol
Secondary 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. Every 30 minutes during the exercise protocol
Secondary Muscle glycogen oxidation Measured by indirect respiratory calorimetry combined with tracer techniques. Every 30 minutes during the exercise protocol, during 3 minutes of expired gas collection.
Secondary 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. Every 30 minutes during the exercise protocol, during 3 minutes of expired gas collection.
Secondary Total carbohydrate oxidation Measured by indirect respiratory calorimetry. Every 30 minutes during the exercise protocol, during 3 minutes of expired gas collection.
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