INFORMATION FOR PARTICIPANTS
TITLE OF STUDY
Co- ingestion of glucose and fructose during endurance exercise at a simulated
altitude of 2500m (~16% O2)
INVITATION TO PARTICIPATE
You are being invited to take part in a research study, but before you decide whether
you will take part, it is important for you to understand why the research is being
carried out and what it will involve. Please take time to read the following information
carefully and discuss it with friends and relatives if you wish. Ask us if there is
anything that is not clear, or if you would like more information (a contact number and
address are at the end of this information sheet). Take time to decide whether or not
you wish to take part.
WHAT IS THE PURPOSE OF THE STUDY?
Ingestion of carbohydrate during exercise of 45 minutes or longer enhances
endurance performance at sea level. High altitude exposure has been shown to
result in changes in carbohydrate and fat utilisation at rest and during exercise with
the possible result of increasing demands for carbohydrate utilisation. At sea level,
co- ingestion of glucose and fructose has resulted in high rates of exogenous
carbohydrate oxidation, this may be important for maintaining exercise performnce at
altitude where reliance on carbohydrates is higher than sea level. This research aims
to understand fuel use (from exogenous and endogenous sources) at altitude in
order to investigate the optimum feeding strategy that should be taken.
The duration of the study is approximately 6 weeks, with a total of 6 visits to the
laboratory at Leeds Metropolitan University. The aim of this study is to provide data
towards a PhD study, Undergraduate and Masters major independent study and
possible publication.
WHY HAVE I BEEN CHOSEN?
We are seeking approximately 8 males, aged between 18 and 40 years to participate
in this study. To participate you must confirm that you are fit and healthy, a nondiabetic and that you are not currently taking, or have recently taken any medication,
which may interfere with this study.
DO I HAVE TO TAKE PART?
It is your decision whether or not to take part. If you decide to take part, you will be
given this information sheet to keep and be asked to sign a consent form at your
appointment, before any assessments. You will be able to ask any questions at that
time. If you decide to take part you are still free to withdraw at any time and without
giving reason. If you decide to withdraw from the study prior to participating in all
parts of data collection, your data will be removed from the study.
WHAT WILL HAPPEN IF I TAKE PART?
You will be asked to make 6 visits to the laboratory at Leeds Metropolitan University
over an approximately 6 week period. Your visits will consist of;


One Maximal Oxygen Uptake Test (aerobic capacity test) and familiarisation
session
Five Experimental Trials (120 minute run plus 5km time trial)
During your initial visit you will take part in a pre screening assessment followed by
your Maximal Oxygen Uptake test which will be at a simulated altitude of 2500m
(using an oxygen concentration of approximately 16%). This test involves a
continuous graded exercise test to volitional exhaustion in order to determine your
 O max). This test will be performed in the Environmental
maximal oxygen uptake ( V
2
Laboratory Facility within the Research Institute with the use of a treadmill.
Throughout the test you will wear a facemask so that expired air can be collected and
 O max.
measured using a Metalyser online gas analysis system to establish your V
2
You will have fingertip blood samples taken from you before, during and after the
tests, these will be carried out by trained researchers. The results of this test will be
used to determine the running speed at which you will perform your experimental
trials. Following a rest period you will then complete a familiarisation treadmill test
which will consist of a 5km time trial. This will be performed at a self selected pace
and during this you will not be required to wear the facemask or give blood samples.
 O max for 120
For the 5 experimental trials you will be required to run at 70% V
2
minutes followed by a performance test consisting of running a 5km time trial at a self
selected pace. All these tests will be performed at 2500m simulated altitude (~16%
 O max result
O2). The running speed of these trials will be determined from your V
2
from the corresponding Maximal Oxygen Uptake test. You will be required to drink
one of five solutions, a different one at each trial, containing either carbohydrate
(glucose only, glucose plus fructose with glucose labelled with 13C stable isotope
tracers, glucose plus fructose with fructose labelled with 13C stable isotope tracers,
glucose plus fructose with glucose and fructose labelled with 13C stable isotope
tracers or a placebo mixture). The solution will be randomised and kept blind from
you so that you do not know which drink you are consuming at each trial.
Procedures are in place to ensure your safety at all time, however there some
possible risks of taking part in the trials. These mainly are associated with the effects
of altitude which can cause headaches, dizziness, nausea and fatigue. You will be
screened prior to the trials and monitored at all times to ensure your safety.
Researchers trained in first aid and advanced resuscitation techniques will be
present throughout.
On arrival at the laboratory you will be fitted with a cannula which is used for taking
blood samples and resting blood samples will be drawn. The cannulation procedure
will be carried out by a trained researcher. You will drink a volume of ~650ml of the
solution and then enter the Environmental Laboratory Facility to begin the run. You
will run with a face mask fitted for gas analysis, you will be familiarised with this prior
to the trials. You will then run continuously for the duration of the trial, stopping 7
times for approximately 1 minute each, once at 15, 30, 45, 60, 75, 90 and 105
minutes to ingest the solution (~250ml at each). At 15, 30, 45, 60, 75, 90 and 120
minutes you will have expired air and blood samples drawn. On completion of the
run you will have final expired air and blood samples taken and the cannula will be
removed. The amount of blood drawn is small (a total of ~180ml of blood will be
drawn) and of very low risk to participants. In fact this volume of blood is less than
the 1 pint drawn in typical blood donor sessions and is well tolerated in healthy
individuals. All blood samples will be stored safe and securely and will be disposed
of appropriately. These procedures will be carried out by a trained researcher and do
not come under the conditions pertaining to the Human Tissue Act as the plasma and
serum only will be stored and these are acellular.
The tests are all carried out within the Environmental Laboratory Facility which
simulates altitude using changes in oxygen concentration to equal the equivalent
partial pressure which would be experienced at ‘real’ altitude. This provides a
normobaric hypoxic environment as opposed to a hypobaric hypoxic environment
where changes in atmospheric pressure occur. In this study the oxygen content will
be set at ~16% to simulate an altitude of 2500m.
WHAT DO I HAVE TO DO?
This study will require you to refrain from alcohol for 24 hours and exercise and food
for 12 hours prior to each of the experimental trials. We will also ask you to refrain
from consuming carbohydrates which are naturally enriched in 13C (e.g. corn, sugar
cane, maize) for the duration of the study (a list of foods to avoid will be provided).
Outside of these constraints there are no restrictions placed upon you to refrain from
your normal lifestyle and/or training.
WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART IN THE STUDY?
The study is being undertaken for research purposes rather than to attempt to find
the causes of disease, or a cure for a disease. You may benefit from participating in
the study if you are interested to learn more about how your body responds to high
altitude and the effects of this on your fuel utilisation.
WHAT HAPPENS IF SOMETHING GOES WRONG?
All of the experimental procedures that will be used in this study have been rigorously
tested to ensure that they meet health and safety standards. These tests are all
routine and are performed regularly on patients and healthy volunteers. The
technicians who perform the tests are all trained and skilled to do so.
In the unlikely event of you experiencing any problems that may be caused by this
study, you must tell us immediately and we will do our utmost to address these.
In the unlikely event of you experiencing any problems that may be caused by this
study you must inform Prof. Rod King immediately (contact details are at the end of
this sheet) and we will do our utmost to address these. Should you be harmed in any
way whilst participating in this study, the University maintains clinical trial Indemnity
insurance. The clinical trial indemnity insurance will only respond in the event that the
University is deemed to be legally liable for incidents that occur, as a direct result of
the study.
WHAT ARE THE POSSIBLE RISKS OF TAKING PART IN THE STUDY?
As previously mentioned, the risks for this study are few and have been assessed.
The primary risks revolve around maximal exercise testing and a possibility of
experiencing acute altitude illnesses such as AMS, however specific protocols are in
place to ensure maximum safety for the participant and researchers.
WILL MY TAKING PART IN THE STUDY BE KEPT CONFIDENTIAL?
All information collected will be kept strictly confidential, other than to those of us who
are directly involved with the study. Any information that leaves the Leeds
Metropolitan University will have names and addresses removed so that you cannot
be recognised from it.
DATA PROTECTION AND OWNERSHIP
Your personal data will be coded at the start of the study by the Principle Investigator
who will be the only person able to trace data back to any participant. The Principle
Investigator’s computer will be in a locked room and password protected. The real
names of the individuals will not be used in reports. The data from the study will be
kept for 10 years following the completion of the study, thereafter it will be destroyed.
WHAT WILL HAPPEN TO THE RESULTS OF THE STUDY?
Once the study has been completed we will write the study up as a research paper to
submit to a journal for possible publication. The study findings will be made available
to interested participants. These data from this study will also be used by
undergraduate and post graduate students as part of their major Independent
Studies and other learning modules, as well as being used in a PhD being
undertaken by Nicola Reeve.
CONTACTS FOR FURTHER INFORMATION
If you require further advice about this study, at anytime during participation, you may
contact Miss Nicola Reeve, Professor Rod King or Dr John O’Hara at Leeds
Metropolitan University who are organising the study.
Nicola Reeve
E-mail: n.reeve@leedsmet.ac.uk
Professor Rod King
E-mail: r.king@leedsmet.ac.uk
Telephone: 0113 8121707
Address: Research Institute – Sport & Exercise Science, Leeds Metropolitan
University, Headingley Campus, Beckett Park, Headingley, Leeds, LS6 3QS
Dr John O’Hara
E-mail: j.ohara@leedsmet.ac.uk
Telephone: 0113 8125239
Address: Carnegie Faculty, Room 107, Research Institute – Sport & Exercise
Science, Leeds Metropolitan University, Headingley Campus, Beckett Park,
Headingley, Leeds, LS6 3QS
If you would like independent advice on the project or participation, or to make a
complaint please contact Dr Theocharis Ispoglou.
Telephone: 0113 8123246
E-mail: t.ispoglou@leedsmet.ac.uk