What are the risks of participating?
The ASPIRE-DNA trial is a low risk intervention, however as with most clinical trials there are minor risks to consider. These include;
- Venous blood tests: At the clinical visits venous blood tests will be done and these have the potential to cause discomfort. This will be minimised by experienced research personnel and the appropriate use of equipment.
- Pregnancy tests: If you are female, of childbearing age and are unsure if you are pregnant at any point during the trial a urine pregnancy test will be carried out at screening and prior to each intervention. You will be excluded from the study if you are pregnant or if you are planning pregnancy within the study time frame, to minimise any potential risk.
- Knowledge of genetic information: Learning about genetic traits can be worrying for some people. Remember that we are not conducting diagnostic testing and that genes are only an indication of predispositions that you may have, they are not a guarantee that you will have the condition that your genes may be related to. In addition, other factors such as the environment or lifestyle choices are very important predictors of our health. Furthermore, we are only looking at genetic variations linked to eating habits.
However, it is important for you to understand that if any problem occurs the research trial team will be on hand to answer any concerns by email. If a problem occurs during any study visits in the hospital, all hospital facilities will be available to manage it. Further information on insurance cover and compensation is also available. You may be eligible for financial reimbursement due to travel expenses and potential increased grocery costs during the trial.