Clinical trials

This research is being carried out to investigate the potential of insects (crickets) as a sustainable protein source for supporting human muscle tissue by comparing cricket protein to a commonly used animal protein (whey). Insects have been used as protein source for many years in East-Asian and African cultures. More recently the interest in this potential protein source has been growing in Western countries due to the negative environmental impact of producing animal foods and the increased awareness of animal welfare issues in the food chain. Insects are a more sustainable protein source, requiring less land, water and feed, and producing less carbon emissions (greenhouse gases) compared to farming livestock (e.g. cows, pigs, chickens etc.) However, up until now there is no clear evidence that insect-derived protein has the same nutritional properties as animal-derived protein. Recent data from our research group indicates that there appears to be no difference in the digestibility of an insect protein compared to a traditional animal protein amongst younger, middle-aged and older adults. The investigators now want to explore the potential of insect protein to increase muscle mass and strength.

Summary in non-technical language Aim(s) of the research We are working on a way to use drones to deliver Automated External Defibrillators (AEDs) - devices that help restart a person's heart by giving it an electric shock. These drones will bring AEDs to people helping someone having a cardiac arrest outside of a hospital setting. Our goal is to make sure everything works smoothly, from the time the emergency call is made to when the AED helps the patient. This research is important because it will help us find out the best process to deliver AEDs by drone and what challenges might come up. Background to the research A cardiac arrest happens when a person's heart suddenly stops, which stops blood from getting to their organs. Acting fast is very important. In the UK, less than 10% of people survive cardiac arrests because it often takes too long to get them the help they need. AEDs can save lives by restarting the heart, but they need to get to the patient quickly. Design and methods used This project has two main parts: 1. Creating the drone delivery process: We will develop a system to get an AED to someone in need, from the moment someone calls 999 to when the AED reaches the patient. This involves working with emergency services, Air Traffic Control, and drone operators. We will test how this works using testing sessions with training manikins at Redhill Aerodrome over four days. We will measure how long things take and gather feedback to improve the process after each session. 2. Interviews: We will talk to people who have been involved in a cardiac arrest, like patients, family members, carers, or members of the public who have helped someone having a cardiac arrest. We will also speak to people who have no experience of cardiac arrests, to understand how they feel about drones delivering AEDs. We want to know if people think this is a good idea and what challenges or concerns they might have. Patient and Public Involvement A group of patients, family members/carers, and members of the public will help us check that our plans are practical and clear and will provide feedback throughout the study. They will also help review the results and create materials to share with the public. We will provide training, so everyone feels comfortable contributing. Dissemination We will keep everyone updated through a newsletter on our website and social media. The public involvement group will review and contribute to these updates. We will also hold public events and share our findings in reports, journal articles, conferences and webinars, so a wide range of people can access the results.

Background Regular exercise can significantly improve physical and mental health during cancer treatment and reduce the time needed in the hospital. Animal studies suggest that exercise training can also reduce the number of cancer cells. For example, exercise training in mice produces more immune cells in the tumour. These immune cells in the tumour contribute to the destruction and reduction of the size of the tumour and are a vital component of effective immunotherapy (cancer treatment that helps the immune system fight cancer). In humans, exercise training and the immune response in tumours are less understood. Only 1 study has investigated the effect of a single exercise session before surgical removal of the prostate in prostate cancer patients. As the benefits of exercise are gained from weeks/months of exercise, no effect on the immune cells in the tumours were found. The investigators have carried out a previous study looking at how exercise affects fitness before major surgery. After this they used state-of-the-art methods to detect and visualise immune cells within the tumour. Compared with the patients who did not exercise, the exercise group had significantly more immune cells in their tumours, consisting of a group of cells that are important for killing cancerous cells called CD8+ T cells. CD8+ T cells in tumours are associated with improved survival outcomes. Importantly, they found a link between changes in fitness and the amount of these cells in the tumour. This suggests that if there is increase in fitness, there also an increase in the frequency of these cells in the tumour. Therefore, the investigators propose performing a clinical trial to find out the best level of exercise patients need to sustain before surgery to produce this improved immune response. The trial will aim to understand how this happens and how the entry of immune cells into the tumour changes the environment around a tumour. The investigators consist of a team of exercise immunologists, tumour immunologists and clinicians working with the Human Performance Institute at the University of Surrey in collaboration with the Royal Surrey NHS Trust. How it will be done The investigators will assess immune cell response in blood samples obtained from oesophageal cancer patients before, during and after a high or low intensity exercise programme. Following the exercise programme, tumour tissue removed at surgery from these patients will be used to investigate the the presence and quantity of these immune cells. Potential impact A better understanding of this is important, as current anti-cancer immune-based therapeutics work best when there is a an immune response within the patient's tumour. Generating evidence that exercise can improve the immune response against the tumour in patients with oesophageal cancer would provide significant justification for introducing "personalised" exercise programmes to improve treatment outcomes.

People with diabetes sometimes consider that they are subjected to unfair discrimination in the occupational or work environment. These include safety-critical activities, such as operating machinery and driving 1-3. Some occupations preclude the use of medications that lower blood glucose, particularly insulin. Safety regulators, occupational health physicians and national organisations frequently have to balance the competing priorities of individual rights against public safety. Modern treatment, with advances in insulin therapy and glucose monitoring, combined with rigorous clinical assessment and review, has allowed stereotypical attitudes to be challenged and advocated individual assessment with respect to safety criteria. Along with the UK Driving and Vehicle Licensing Agency (DVLA) and Civil Aviation Authority (CAA), the Maritime and Coastguard Agency (MCA) have accepted that insulin-treated diabetes should not be an absolute contra-indication to partaking in these occupational activities4. However, as the Disability Discrimination Act (1995) recognises that there may be specific employment-related hazards, fitness to work should be assessed on an individual basis. Therefore, each of these transport agencies has established regulatory standards for their respective domains, with the priority of minimising hypoglycaemic incapacitation risks. The CAA, for example, has worked alongside other European countries to use the ARA.MED.330 protocol and require medically certified pilots to check their blood glucose levels regularly before and during flights. In 2010, the UK CAA's expert committee reviewed the knowledge and policies concerning flying and it was decided that Continuous Glucose Monitoring (CGM) systems were not accurate enough and instead used finger prick-blood glucose monitoring (SMBG) as the gold standard. Since then, the protocol has been successfully implemented and there are current works in progress that demonstrate sufficient accuracy in modern CGMs as a viable alternative to SMBG. Similarly, the guidelines devised by the MCA, Approved Doctor's Manual (ADM), place a great emphasis on the type and treatment of diabetes, with the primary concern being risks of cognitive impairment or incapacitation5. Emphasis is placed on the need for able glycaemic control and "full awareness of impending hypos, with no reported or observed significant hypoglycaemic episodes in the last year". The guidance stipulates that certification may be restricted on individuals pending their medication side effects, compliance, and vascular risk factor control. Previous regulations prevented seafaring individuals such as insulin-treated seafarers from partaking in lone watchkeeping/lone-working roles and restricted them to near-coastal duties (150-200 nautical miles) (Appendix 1). Current regulations allows for exemptions for certain vessels, provided that the seafarer's diabetes control remains stable and is subject to blood glucose monitoring. Regardless, an approved medical assessor is needed to conduct these specific medical assessments in line with the statutory standards in MSN 1886 and guidance in the ADM. All seafarers who are insulin-dependent and licenced to undertake seafaring in the UK will be invited to participate in this study.

The aim this study is to investigate the effects of time-restricted eating (TRE) on body composition, muscle function and markers of metabolic health of adults over 60 years old. This study will compare different variations of TRE - with and without an additional protein. This study involves attending two study days at the University of Surrey for baseline and end-of-intervention measurement of body composition using a gold-standard dual energy x-ray absorptiometry (DEXA) scan; muscle function using hand grip strength and 30-second sit-to-stand tests; weight. A blood sample will be taken at each study visit to measure markers of lipid and glucose control, and insulin sensitivity. Participants will be randomly allocated to one of four study groups: * control group: maintain habitual dietary patterns * TRE group: fast for 16 hours overnight, eat between 12-8pm * TRE + Protein (AM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the morning * TRE + Protein (PM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the afternoon Participants will be asked to follow the intervention according to their allocated group for 8 weeks.

Managing a strict gluten-free diet is crucial for children and young people with coeliac disease. However, this can have adverse effects on psychological well-being and quality of life. Despite appeals from families, clinicians, and researchers, psychological support is not routinely provided to these families. A feasibility project (NCT06007898) adapted existing self-help psychological resources used for food allergy, gastrointestinal disease, and type one diabetes to cater to families dealing with coeliac disease. This feasibility randomised controlled trial was conducted with 100 families and highlighted the viability and acceptability of this self-help resource. This pilot study was conducted in consultation with caregiver(s), clinicians, and CYP living with coeliac disease. These consultations confirmed a lack of support in this area and the enthusiasm for self-help psychological interventions. We will now run a full randomised controlled trial to evaluate the effectiveness of the intervention for caregiver(s) of CYP with coeliac disease in supporting the appropriate management of the gluten-free diet, alongside psychological wellbeing. For this trial, 172 families will complete well-being and quality of life questionnaires, along with assessments of their child's gluten-free dietary management. Families will be divided into groups receiving the psychological resources either immediately or after a five-month delay. Follow-up questionnaires will be administered at one, two, and five months for all families, regardless of intervention access. Feedback on the resources and research participation will be gathered. The expectation is that these self-help psychological resources for parents will enhance gluten-free diet management, quality of life for coeliac children and young people, and well-being for parents.

Currently, there are few opportunities for patients with cancer to have individual exercise guidance, and this has further been impacted by the Covid-19 pandemic. However, during the pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer patients. The investigators think that remote exercise training may also offer a solution to support positive change in prostate cancer patients. As a result, the investigators have developed a remote/online exercise programme to explore this further. This study will explore the effectiveness of an 8-week remote exercise and behavioural support intervention, and whether prostate cancer patients feel they benefit from this. The study also aims to see if this sort of exercise programme can be delivered to more prostate cancer patients in the future. This project is open to men with prostate cancer on long term hormone therapy. The intervention will be comprised of one remote supervised session per week, completed 1-1 using an online platform and up to two additional sessions, depending on its suitability for the patient, will be prescribed as unsupervised home-based exercise.

Vitamin D deficiency remains a global public health issue (Wilson 2017). In the United Kingdom (UK). There is a lack of research looking at vitamin D status of the British African-Caribbean population. This population is particularly at risk to vitamin D deficiency due to possessing a skin type which hinders the production of vitamin D in the skin. Further, due to the geographical location of the UK, there is reduced ability to produce vitamin D due to the low sun exposure (Libon 2013 ). Our main source of vitamin D is through skin exposure to the sun. In the UK, the UV radiation is only strong enough in April-September (Wilson 2017) for the production of vitamin D to occur. In winter months, vitamin D needs to be consumed in food or supplement form. Vitamin D is essential for healthy bones and is associated with reduced risk of certain cancers and immune disorders (Wilson 2017). There is strong epidemiological evidence linking low vitamin D status with diabetes, cardiovascular disease, osteoporosis, osteoarthritis and some cancers (NatCen 2018). This observational study will aim to determine the vitamin D status of British Afro-Caribbean women, as well as determine the effects of sun exposure, dietary vitamin D intake, muscular strength, lifestyle and anthropometrical (height, weight etc.) factors have on vitamin D status. The study will be conducted at the University of Surrey. The study will take place in Autumn and winter 2019/2020 and a repeat study in Spring 2020. Each participant will require two visits to the university, each session will take approximately 2 hours. The study is funded by the University of Surrey. The findings of this study may lead to strategies for improving vitamin D status in this population, as well as improving guidelines to assist darker-skinned people regarding sunlight exposure in high latitudes.

This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise.