Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT02667340 |
| Other study ID # |
10009797 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
January 19, 2016 |
| Last updated |
January 25, 2016 |
| Start date |
February 2016 |
| Est. completion date |
August 2017 |
Study information
| Verified date |
January 2016 |
| Source |
University of Western Ontario, Canada |
| Contact |
Pete w Lemon, PhD |
| Phone |
519-661-2111 |
| Email |
plemon[@]uwo.ca |
| Is FDA regulated |
No |
| Health authority |
Canada: Health Canada |
| Study type |
Interventional
|
Clinical Trial Summary
To assess the efficacy of a hydrothermally modified starch supplement (Superstarch made
byGeneration UCAN) vs isoenergetic placebo (glucose) on exercise performance, execution of
specific soccer skills, and on cognitive function during and following a simulated soccer
game.
Secondary: To compare fat oxidation and carbohydrate oxidation (based on RER data) during
the game with Generation UCAN vs isoenergetic placebo (glucose).
Description:
This will be a double blind cross over study. There will be two treatments involved:
Superstarch and glucose (placebo). Participants and investigators will be blinded as an
individual not involved in the project will prepare and distribute the treatment (drinks)
according to a coding system that is kept confidential until the study is completed.
Participants will complete each treatment once and the treatment order will be
systematically rotated to avoid any order effect. Healthy men and women soccer players aged
18-35 yr will be recruited. Participants will come to the lab on five different occasions to
complete two familiarization sessions, a baseline testing session, and two main trials.
During the first visit, the participants will be asked to complete a physical activity
readiness questionnaire (as approved previously; Par Q and a participant information form
for personal and familial health history to rule out any pathologies or health issues that
may preclude them from participating in the present study. Subsequently, the investigators
will collect data for VO2max, body composition and sprinting speed. In the second visit,
participants will be familiarized with the high intensity intermittent exercise protocol to
be used during the study days and will also be allowed to practice the cognitive and skill
tests to be used (up to 8 times in order to remove any learning effect that may influence
the results). During the third visit, baseline scores for the skill tests will be collected.
Participants will perform 4 attempts (the first two will be for re-acclimation) and the last
two will be recorded. The remaining two visits will be the study days and will be separated
by at least 1 week. The order of treatments will be randomized to avoid any order effect.
The night before study day, participants will arrive at the laboratory at 19:00 h and will
be fed a standardized meal containing 2g/kg of carbohydrate (pasta and tomato sauce) and
will not be allowed any food or drink except water thereafter. On the study day,
participants will arrive to the lab at 07:30 h following an overnight 12h fast and will have
refrained from exercise, caffeine or alcohol within the prior 24 hours. Baseline capillary
blood lactate and blood glucose will be obtained by fingerprick by a trained phlebotomist.
In order to ensure the prevention of infection and or contamination during sampling,
standard sterile blood handling techniques will be used including the use of new medical
examination gloves, alcohol swabs, and disposable sterile lancets. All blood-contaminated
materials will be disposed of in a hazardous material labeled disposal (or sharps)
container, promptly after analysis. Subsequently, baseline data for the cognitive tests will
be collected. After collecting baseline data, the corresponding treatment will be given and
30 minutes after, participants will perform a standardized 10-minute warm-up, followed by
the exercise session. The exercise session consists of a 60- minute simulated soccer game
divided into 4 x 15-minute blocks exercising (running) at varying intensities that replicate
the activity pattern of soccer such as sprinting, jogging, cruising, walking etc. The
proportion of time spent at each speed will be allocated based on a time-motion analysis of
professional soccer players observed by Reilly and Thomas (1976) as indicated by Clarke et
al (2008). During each 15-minute block, cognitive function will be tested using the serial
seven subtraction test and the Flanker test. Also, expired gas samples will be collected
during the last 4 min of each standardized 15-minute block to estimate carbohydrate and fat
oxidation. A fingerprick blood lactate and blood glucose sample will be collected at the end
of each 15-minute block. Ratings of perceived exertion will also be taken at the end of each
block. Water will be available ad-libitum during the first test day and will be quantified.
The same amount of water will be provided for the remaining trial. After completion of the
60-minute simulated soccer game, we will test physical performance using a repeated sprint
ability test comprised of twelve, 30m sprints with 35sec of walking recovery between each
sprint. Subsequently, technical skills will be assessed using a battery test comprised of
the Slalom Dribble test and the Loughborough Soccer Passing Test (LSPT). The Slalom Dribble
test is a skill test that requires participants to dribble a soccer ball around a set
obstacle course taking the least amount of time possible whereas the LSPT is a test that
requires participants to accurately pass a soccer ball a set number of times towards
coloured targets while negotiating a coned area, as quickly as possible.
