WOULD YOU LIKE TO KNOW HOW FIT YOU ARE AND HOW YOUR APPETITE RESPONDS TO EXERCISE?
We are looking for female volunteers to participate in a research study investigating the effects of exercise on appetite biomarkers
If you are:
· a woman aged between 18 and 45 years
· heavier than you would like to be
· healthy but not a regular exerciser
· a non-smoker
· and you are keen to cycle
* (all food will be provided for 4 days)
Then you might like to take part in our study
If you think that you might be interested or would like more information, without any obligation to participate, then please contact either:
Eirini Manthou Tel.: 0141 201 0486, E-mail : eirinimanthou@yahoo.gr
or
Dr Dalia Malkova Tel. : 0141 201 0648, E- mail: dm88n@clinmed.gla.ac.uk
Tuesday, 23 October 2007
Monday, 15 October 2007
Energy Balance and Exercise study
Project Title: Energy balance control in response to a single exercise session
(Lay title: Energy balance and exercise)
You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. Thank you for reading this.
What is the purpose of the study?
Our purpose is to investigate how exercise modifies the response of various hormones and other factors in the blood which affect appetite and metabolism after meal consumption. The results will help us to understand more about how exercise helps people to maintain a healthy body weight.
Why have I been chosen?
You have been chosen because you are a healthy adult woman aged between 18-45 years who is somewhat heavier than the ideal weight for your height.
Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.
What will happen to me if I take part?
1) In the first instance will be asked to meet us for a screening visit in which we will:
• discuss with you and complete confidential questionnaires regarding your health, diet and physical activity patterns to ensure that it is perfectly safe for you to participate in this study
• measure your blood pressure, height and weight to enable us to determine whether you fall into the group of people we wish to study
• give you digital scales and diet diaries and instructions on how to use them
• provide an opportunity for you to ask questions
2) We will then ask you to undertake a number of preliminary tests consisting of fitness test, body composition measurements and dietary assessment. These will include:
• Fitness Test. This test will be performed on an exercise bike. The test will be of ~25 minutes duration and will consist of 5 stages of increasing intensity. During the test your heart rate will be measured using a monitor attached to your chest and we will collect samples of the air that you breathe out via a mouthpiece. This will enable us to determine your fitness level and calculate the intensity for your later exercise session. The test will not involve a maximal effort.
• Body composition measurements. This will involve measurements of height and body mass and body fatness by using Tanita body composition scales. Tanita scales send a very low, safe electrical current through the body, which meets resistance from fat tissue but passes freely through lean tissue and thus assess body composition from the level of resistance met. This is completely painless. We will also measure round your waist and hips.
• Food diary. You will be given digital kitchen scales and food diaries with written instructions and will be asked to keep records of all foods and drinks consumed for two days prior to your first trial. Two days before your next visit you will be asked to repeat this diet.
3) After the preliminary tests you will be ready to participate in 2 main experimental trials, on exercise and another control. Each of the trials will take place over two days and last for approximately 24 hours (including overnight sleep at home).
Day 1 – You will be asked to consume breakfast and lunch at home by using food provided by us in advance. You will be advised to eat as much as you want and bring the rest back. On the afternoon of Day 1 you will be asked to come to laboratory and either cycle at a moderate intensity for ~60-90 minutes (exercise trial) or rest quietly for the same duration (control trial). At the start and end of exercise and at the equivalent times during the control trial, samples of expired air and blood will be taken by a qualified and experienced person. You will also be asked to fill a short appetite questionnaire. Then you will be provided with buffet style dinner which will be composed of a variety of foods. We will ask you to consume food from this buffet according to your appetite. You will then have your overnight rest at home.
Day 2 – You will arrive in laboratory at ~8:00 h and stay with us for whole day (~until 6:00 pm). A qualified and experienced person will insert a cannula (a tiny sterile plastic tube) into a vein of your arm, which we will use to take blood. During the day you will be provided with buffet style breakfast, lunch and dinner. The buffets will be composed of a variety of food that you can consume to appetite. Personal preferences will be taken into consideration. Samples of expired air and blood will be taken before and after each meal and every 30-60 minutes between meals. Following each blood sample you will be asked to fill in a short appetite questionnaire.
What else do I have to do?
Other than the specific tasks described above, we ask you to maintain your usual lifestyle but for two days prior to each trial refrain from alcohol, caffeine and exercise and keep dietary diaries which you will be asked to replicate before the next trial.
What are the possible disadvantages and risks of taking part?
• Fitness testing will not be at a maximal level but the possibility exists that, very occasionally, certain changes may occur during or shortly after the tests. They include abnormal blood pressure, fainting or a change in the normal rhythm of the heart beat.
• Blood sampling via the cannula may cause minor bruising, an inflammation of the vein or haematoma (a small accumulation of blood under the skin). Good practice, however, minimises this risk. Some people may feel faint when they give blood.
• There is a small possibility that taking part in this study will reveal a health problem that you already have such as high blood pressure. If such a problem is revealed, we will inform your GP to ensure that you receive appropriate treatment.
What are the possible benefits of taking part?
There may be no benefits to you but as a result of taking part in this study you will receive information about your level of physical fitness and diet. The findings of this study will be published in scientific journals so that understanding about how exercise influence energy balance regulation in the fasted state and after meal consumption. We will provide you with feedback about the main study findings and also about your own results and would be delighted to explain results and discuss the implications with you.
What if something goes wrong?
The chance of something going wrong is extremely small. All of the procedures involved in this study are low risk and our screening tests are designed to ensure that you will only participate if it is safe for you to do so. In the unlikely event that you are harmed due to someone's negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal University of Glasgow complaints mechanisms may be available to you.
Will my taking part in this study be kept confidential?
All information that is collected about you during the course of the research will be kept strictly confidential. Any information about you that leaves the University will have your name and address removed so that you cannot be recognised from it.
What will happen to my samples after the study has finished?
The blood samples that you provide for this study may be useful for future research into the prevention and treatment of excess body weight gain and related conditions such as diabetes and heart disease; this may involve analysis of certain genes associated with these diseases. Any use of your samples for future research will require further approval from a Research Ethics Committee and samples will be analysed in such a way that the results will not be directly traceable to you. If you do not wish your samples to be used for future research, please indicate this on the consent form.
Who has reviewed the study?
This study has been reviewed and approved by the Faculty of Biomedical and Life Sciences Ethics committee at the University of Glasgow.
Contact for Further Information
Any questions about the procedures used in this study are encouraged. If you have any doubts or questions, please ask for further explanations by contacting Eirini Manthou, tel: 0141 201 0486, e- mail: e.manthou.1@research.gla.ac.uk or Dr Jason Gill, tel: 0141 3302916, e- mail: j.gill@bio.gla.ac.uk or Dr Dalia Malkova, tel: 0141 201 0648, e-mail: dm88n@clinmed.gla.ac.uk
You will be given a copy of this information sheet and a signed consent form to keep for your records.
(Lay title: Energy balance and exercise)
You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. Thank you for reading this.
What is the purpose of the study?
Our purpose is to investigate how exercise modifies the response of various hormones and other factors in the blood which affect appetite and metabolism after meal consumption. The results will help us to understand more about how exercise helps people to maintain a healthy body weight.
Why have I been chosen?
You have been chosen because you are a healthy adult woman aged between 18-45 years who is somewhat heavier than the ideal weight for your height.
Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.
What will happen to me if I take part?
1) In the first instance will be asked to meet us for a screening visit in which we will:
• discuss with you and complete confidential questionnaires regarding your health, diet and physical activity patterns to ensure that it is perfectly safe for you to participate in this study
• measure your blood pressure, height and weight to enable us to determine whether you fall into the group of people we wish to study
• give you digital scales and diet diaries and instructions on how to use them
• provide an opportunity for you to ask questions
2) We will then ask you to undertake a number of preliminary tests consisting of fitness test, body composition measurements and dietary assessment. These will include:
• Fitness Test. This test will be performed on an exercise bike. The test will be of ~25 minutes duration and will consist of 5 stages of increasing intensity. During the test your heart rate will be measured using a monitor attached to your chest and we will collect samples of the air that you breathe out via a mouthpiece. This will enable us to determine your fitness level and calculate the intensity for your later exercise session. The test will not involve a maximal effort.
• Body composition measurements. This will involve measurements of height and body mass and body fatness by using Tanita body composition scales. Tanita scales send a very low, safe electrical current through the body, which meets resistance from fat tissue but passes freely through lean tissue and thus assess body composition from the level of resistance met. This is completely painless. We will also measure round your waist and hips.
• Food diary. You will be given digital kitchen scales and food diaries with written instructions and will be asked to keep records of all foods and drinks consumed for two days prior to your first trial. Two days before your next visit you will be asked to repeat this diet.
3) After the preliminary tests you will be ready to participate in 2 main experimental trials, on exercise and another control. Each of the trials will take place over two days and last for approximately 24 hours (including overnight sleep at home).
Day 1 – You will be asked to consume breakfast and lunch at home by using food provided by us in advance. You will be advised to eat as much as you want and bring the rest back. On the afternoon of Day 1 you will be asked to come to laboratory and either cycle at a moderate intensity for ~60-90 minutes (exercise trial) or rest quietly for the same duration (control trial). At the start and end of exercise and at the equivalent times during the control trial, samples of expired air and blood will be taken by a qualified and experienced person. You will also be asked to fill a short appetite questionnaire. Then you will be provided with buffet style dinner which will be composed of a variety of foods. We will ask you to consume food from this buffet according to your appetite. You will then have your overnight rest at home.
Day 2 – You will arrive in laboratory at ~8:00 h and stay with us for whole day (~until 6:00 pm). A qualified and experienced person will insert a cannula (a tiny sterile plastic tube) into a vein of your arm, which we will use to take blood. During the day you will be provided with buffet style breakfast, lunch and dinner. The buffets will be composed of a variety of food that you can consume to appetite. Personal preferences will be taken into consideration. Samples of expired air and blood will be taken before and after each meal and every 30-60 minutes between meals. Following each blood sample you will be asked to fill in a short appetite questionnaire.
What else do I have to do?
Other than the specific tasks described above, we ask you to maintain your usual lifestyle but for two days prior to each trial refrain from alcohol, caffeine and exercise and keep dietary diaries which you will be asked to replicate before the next trial.
What are the possible disadvantages and risks of taking part?
• Fitness testing will not be at a maximal level but the possibility exists that, very occasionally, certain changes may occur during or shortly after the tests. They include abnormal blood pressure, fainting or a change in the normal rhythm of the heart beat.
• Blood sampling via the cannula may cause minor bruising, an inflammation of the vein or haematoma (a small accumulation of blood under the skin). Good practice, however, minimises this risk. Some people may feel faint when they give blood.
• There is a small possibility that taking part in this study will reveal a health problem that you already have such as high blood pressure. If such a problem is revealed, we will inform your GP to ensure that you receive appropriate treatment.
What are the possible benefits of taking part?
There may be no benefits to you but as a result of taking part in this study you will receive information about your level of physical fitness and diet. The findings of this study will be published in scientific journals so that understanding about how exercise influence energy balance regulation in the fasted state and after meal consumption. We will provide you with feedback about the main study findings and also about your own results and would be delighted to explain results and discuss the implications with you.
What if something goes wrong?
The chance of something going wrong is extremely small. All of the procedures involved in this study are low risk and our screening tests are designed to ensure that you will only participate if it is safe for you to do so. In the unlikely event that you are harmed due to someone's negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal University of Glasgow complaints mechanisms may be available to you.
Will my taking part in this study be kept confidential?
All information that is collected about you during the course of the research will be kept strictly confidential. Any information about you that leaves the University will have your name and address removed so that you cannot be recognised from it.
What will happen to my samples after the study has finished?
The blood samples that you provide for this study may be useful for future research into the prevention and treatment of excess body weight gain and related conditions such as diabetes and heart disease; this may involve analysis of certain genes associated with these diseases. Any use of your samples for future research will require further approval from a Research Ethics Committee and samples will be analysed in such a way that the results will not be directly traceable to you. If you do not wish your samples to be used for future research, please indicate this on the consent form.
Who has reviewed the study?
This study has been reviewed and approved by the Faculty of Biomedical and Life Sciences Ethics committee at the University of Glasgow.
Contact for Further Information
Any questions about the procedures used in this study are encouraged. If you have any doubts or questions, please ask for further explanations by contacting Eirini Manthou, tel: 0141 201 0486, e- mail: e.manthou.1@research.gla.ac.uk or Dr Jason Gill, tel: 0141 3302916, e- mail: j.gill@bio.gla.ac.uk or Dr Dalia Malkova, tel: 0141 201 0648, e-mail: dm88n@clinmed.gla.ac.uk
You will be given a copy of this information sheet and a signed consent form to keep for your records.
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