Join the HAVEN study
Am I eligible to take part?
You are eligible to take part in this study if you are over 50 years of age.
You are NOT eligible to take part in this study if you have any of the following:
- Any clinically diagnosed psychiatric or neurological conditions (e.g. schizophrenia, depression, autism, etc)
- Diagnosed cardiovascular disease, diabetes, liver disease, or hypertension
- Diagnosed bleeding disorder (e.g. platelet function defects, haemophilia)
- Any metal implanted in your body
- Currently take anticoagulant or antiplatelet medication (e.g. clopidigrel, ticagrelor, warfarin, rivoroxaban)
- Suffer from claustrophobia (the brain scanner is an enclosed space)
Do I have to take part?
This is completely your decision, participation in this study is voluntary. If you choose to participate you will need to sign a consent form. After signing the consent form you are still free to withdraw from the study at any time. You will not need to give a reason why, and it will not affect your relationship with the University of Reading or any of the researchers involved in the study.
Who is it being run by?
This study is being jointly run by the Centre for Integrative Neuroscience and Neurodynamics (CINN) and The Institute for Cardiovascular and Metabolic Research (ICMR). It has been reviewed and approved by the University of Reading University Research Ethics Committee.
What will I have to do if I take part?
Participation in the study will require you to visit the University of Reading for approximately 4.5 hours. Information about each of the procedures in the study is provided below.
Before your visit
On the day before your visit, please avoid doing strenuous exercise or drinking alcohol.We will give you a diet diary to complete so we know what foods you have eaten on that day. We will also ask you to eat a specific meal the evening before your visit, and will provide you with the meal.On the day of your visit, it is important you don’t have anything to eat or drink (other than water) before you come in. This is because eating and drinking can affect some of the tests we need to conduct at the beginning of the visit. We will give you a meal halfway through your visit. Where possible we will ask everyone to eat the same meal, but we will be able to accommodate dietary requirements.
Video study session (approx 1 hr)
You will watch a video of a TV programme lasting about 1 hour. We will ask you to watch the video closely and concentrate throughout, since later you will be given a memory test involving the video. We are particularly interested in how your memory works, and the regions of your brain that are involved in memory.
Blood vessel function (approx 30 mins)
‘Laser Doppler Imager’ (LDI) is used to measure vascular function. Two small Perspex rings containing a small amount (~2.5 ml) of two liquids will be placed on your forearm and a very small current will be applied to allow the chemicals to pass through the skin barrier (‘iontophoresis’). The chemicals stimulate the small blood vessels located under the skin to relax and increase the flow of blood. The LDI will continually monitor this response over 20 min by using a clinical laser to scan the rings on your arm. In total, LDI will take approximately 30 min per measurement.
The action of the chemicals on your blood vessels is short-term and restricted to the small area of skin (approx. 10 cm) where they are applied. The procedure is pain-free; however, it is usual for some participants to experience some redness and irritation after iontophoresis but this should only last for 10 min. Throughout the LDI measurement, participants will be required to wear suitable eye protection and the researchers will ask you to remove or cover any jewellery on your measurement arm. Creams and lotions should also not be used on your arms as this can affect the measurement.
Blood sample (approx 15 mins)
We will take a blood sample from your arm. We will take 30ml of blood (about 2 tbsp). The blood sample will be taken by someone who is trained and experienced. We will use this blood sample to measure how your blood clots and your blood sugar, blood fat and haemoglobin levels.
Food break (approx 30 mins)
After you have had your blood taken, you will be given a meal and have time to eat and relax before the other assessments. Where possible we would like everyone eat the same meal, but we will be able to cater for dietary requirements.
Cognitive tasks (approx 15 mins)
This will be a test of your short-term memory – your ability to memorise things the researcher tells you. The researcher will give you a list of words and you will have to repeat the list from memory.
Brain scan (approx 2 hrs)
You will have a brain scan in an MRI scanner to measure your brain structure and function (MRI stands for magnetic resonance imaging).
- Resting measures. You will first be asked to relax in the MRI scanner while a researcher takes resting measurements of your brain.
Memory test. After these measurements are complete you will be given a memory test on the video you watched earlier. You will complete this test while in the MRI scanner, and we will be able to take measurements of how your brain is functioning while you complete the test. The memory task will take about 30 minutes.
Brain blood vessel health. Finally, to measure your brain blood vessel health, we will test how the blood vessels in your brain respond to changes in carbon dioxide. This test will have two parts. You will need to breathe from a large bag containing slightly higher-than-normal levels of carbon dioxide (5%) for 5 minutes. You will then have to breathe faster-than-normal (30 breaths per minute) for 5 minutes, which will reduce your carbon dioxide levels to lower-than-normal.
Expenses and payment
You will receive £40 for your time and contribution to the research.
What are the benefits of taking part?
Participation of the current study will enable you to:
- Obtain an image of your brain
- Obtain information about your body and health
- Experience what it is like to participate in a laboratory testing environment
- Contribute to scientific research into body and brain health as we age
- Contribute to the training of student researchers who are collaborating on the study
Participation in this research will have no direct health benefits for you. None of the tests or procedures in the study can be used for the purposes of diagnosing or managing illness.
What are the risks of taking part?
There are some risks associated with participating in this study. These risks are:
Common (about 25% chance)
- Blood vessel function test – Redness or itching
During this technique, a weak electrical current will deliver drugs to your skin blood vessels. This non-invasive technique is safe, but sometimes causes brief redness or itching which will go away within 20–30 minutes after the procedure.
Less Common (less than 10% chance)
- Blood sample – bruising
There is a chance (about 1 in 50) that venous blood sampling may leave a bruise on your arm. The risk of this will be minimised because the researcher taking your blood will be trained and experienced.
Rare (less than 1% chance)
- Brain scan – breathing higher-than-normal levels of carbon dioxide
This can result in short-term and mild side effects. These include nausea, flushing, hyperventilation (breathing faster than normal), anxiety, sensory stimulation, and feelings of panic. To reduce these risks, trained staff will monitor you for these symptoms before, during, and after this test, and will stop the test if you begin to experience any of these symptoms.
- Brain scan – claustrophobia
The MRI scanner is a confined space, and it is possible you may suffer psychological stress, anxiety, or claustrophobia. The risk is expected to be 1 in 200 (0.5%). If you know you suffer from claustrophobia we will not complete an MRI scan on you. Whilst you are in the scanner, we will provide you with a panic button which you can press to stop the scan at any time. There is more information about what it is like to have an MRI scan in the MRI Participant Information Sheet which you have received alongside this information.
Please ask us if you have questions. You should not sign the form consenting to take part in the study if you still have unanswered questions or any doubts. Please feel free to contact any of the researchers. For more information or if you have any questions, please contact Dr Gabriella Rossetti at firstname.lastname@example.org.