Clinical trials

The goal of this clinical trial is to learn if a postbiotic supplement can reduce stomach and gut symptoms in physically active women. The main questions it aims to answer are: Does the supplement reduce gut symptoms during the menstrual cycle? Does it improve symptoms related to exercise? Researchers will compare the postbiotic supplement to a placebo (a look-alike capsule that contains no active ingredient) to see if the supplement works. Participants will be physically active, premenopausal female athletes. Participants will: Take either the postbiotic supplement or a placebo each day for two menstrual cycles Track their menstrual cycle and training Report gut symptoms using regular questionnaires Provide stool samples to assess gut health This study will help researchers understand whether postbiotic supplements can improve gut health and reduce symptoms that may affect training and performance in female athletes.

This project aims to bridge the gap between technology and healthcare by developing a biofeedback intervention that enables daily monitoring of atrial fibrillation episodes and physical activity levels. The main question it aims to answer is: Is a co-designed, usability-tested, bio-feedback intervention aimed at nudging patients with paroxysmal atrial fibrillation to increase physical activity feasible for a larger randomised control trial? The trial is split into two separate phases, each adopting different study designs, data collection, and data analysis methods. Phase 1 Co-design and usability testing: In this phase, we aim to test if smartwatches can be used to monitor AF and physical activity so that personalised atrial fibrillation-specific summaries can be created and sent to participants as text message nudges. The aim is to encourage participants to be more physically active. Participants will wear a smartwatch for 3 weeks, during which they will receive text messages giving them feedback on their atrial fibrillation and physical activity. After the 3 weeks, all participants will take part in a workshop to provide feedback on what they thought and what could be improved. Improvements will be implemented by the researchers, and the process will repeat for a total of two iterations. On the first iteration only, participants will also be asked to wear a Holter monitor OR chest strap and an additional smartwatch for the first 24 hours, alongside an accelerometer watch for the first 7 days. Phase 2 Feasibility study with embedded process evaluation: This phase aims to assess whether it is feasible and acceptable to run a larger trial across the UK (i.e. can the intervention be delivered properly and do patients think it is useful). Participants will be randomly allocated to either their normal standard of care, or to receive a smartwatch with the biofeedback messaging service in addition to their normal standard of care. The study will take 6 and a half months in total. Both groups will complete online questionnaires periodically over this period. Both groups will also need to wear a smartwatch and accelerometer watch for 7 days before and after testing.

This study aims to investigate the extent to which vegan or plant-based, omnivorous, and carnivore dietary patterns affect LDL aggregation susceptibility (the affinity for LDL cholesterol particles to clump together in the blood), which may promote plaque build-up in arteries. Using a cross-sectional mixed-methods design, the study will measure LDL aggregation, blood lipids, and other metabolic biomarkers in individuals following these diets, and combine these data with dietary and behavioural information to examine links with cardiovascular and metabolic health.

The goal of this clinical trial is to learn whether following a Mediterranean-style diet or a Carnivore-style diet can improve heart and metabolic health in men and women aged 30-60 years with high LDL cholesterol. The main questions it aims to answer are: 1. Does following a Mediterranean or Carnivore diet change how easily LDL cholesterol particles clump together (LDL aggregation susceptibility)? 2. Do these two diets have different effects on other measures of heart and metabolic health, such as blood fats, blood vessel function, and overall wellbeing? Researchers will compare people who follow the Mediterranean-style diet with those who follow the Carnivore-style diet to see which diet produces more beneficial changes in cholesterol and heart health markers. Participants will: * Attend three visits at Liverpool John Moores University for screening and data collection. * Be randomly assigned to follow either the Mediterranean or Carnivore diet for 3 weeks, matched for calories and protein. * Provide fasting blood, urine, and stool samples before and after the diet period. * Complete non-invasive cardiovascular tests to measure blood vessel and heart function. * Take part in a short interview and complete questionnaires about their experience of following the diet.

Female athletes are often overlooked in scientific research, including the understanding of their digestive system and its impact on overall health, training, and performance. The gastrointestinal (GI) system plays a critical role in supporting digestion, nutrient absorption, and acting as a protective barrier for the body. While there is some knowledge about the differences in GI structure and function between males and females at rest, there is a lack of understanding regarding how these differences manifest during exercise, especially among female athletes and at different phases of the menstrual cycle. It has been observed that female athletes commonly report a higher prevalence of GI symptoms compared to males, with many experiencing an increase during menstruation. These symptoms, including bloating, abdominal discomfort, and irregular bowel movements, can significantly disrupt an athlete's training and performance. Elite female athletes have acknowledged that GI symptoms associated with the menstrual cycle have led to altered or disrupted training routines. While these symptoms are commonly recognized to affect a large portion of the female population, few interventions have been studied to assist in managing this discomfort. Some clinicians may direct their patients to take pain-relieving medications without any thoughts on the consequences of chronic use. One potential strategy to reduce GI symptoms during endurance exercise is probiotic-postbiotic supplementation. Various probiotic supplements have been shown to effectively decrease diarrhoea, constipation stress, and intestinal permeability, as well as impact immunologic outcomes. Postbiotics differ from probiotics in that they are made from microorganisms that are not alive. They allow the modulation of the composition and function of the gut microbiota and enhance the intestinal barrier to prevent unwanted substances from entering the body proper. While these biotics can relieve lower GI symptoms in irritable bowel syndrome (IBS), there is less consensus regarding their efficacy in modulating exercise-associated GI symptoms. Previous research by Pugh et al., 2019 has demonstrated that four weeks of probiotic supplementation was able to reduce GI symptoms during a marathon race, however this work was predominantly conducted in males and did not take menstrual cycle in consideration. This is important given that symptoms are commonly higher in the early follicular phase when a female experiences their period. Therefore, the aim of this study is to assess the effects of postbiotic supplementation on GI symptomology in female athletes. The aim of this present study is to investigate the influence of postbiotic supplementation on menstrual cycle symptoms and exercise-associated GI symptoms in female endurance athletes while exercising compared to symptoms while taking a placebo.

A randomised, crossover, counterbalanced repeated measures study will be conducted to examine the effect of acute heat exposure on rate of change in blood glucose concentration during 40 minutes of moderate-intensity exercise and for 30 minutes after exercise. Participants will complete two experimental conditions during two separate laboratory visits, with the order of conditions randomised. One condition will be a temperate condition of 20°C with 50% relative humidity (Temperate), the other will be 40°C with 50% relative humidity (Heat). Visits will be identical, including time of day, except for the condition. Visits will be separated by 24h. Testing will take place in the laboratories of the Research Institute for Sport and Exercise Sciences at Liverpool John Moores University.

The aim of this research is to 1) test how the skin blood vessels and sweat glands function in women who experience hot flushes by using skin microdialysis to deliver small amounts of substances to the skin that cause increased skin blood flow and sweating, and 2) examine the structure of the skin blood vessels and sweat glands in the skin of women who experience hot flushes by taking a very small skin biopsy. Any changes in the function or structure of the skin blood vessels or sweat glands in women with hot flushes would increase our understanding of what causes hot flushes and help to design effective treatments.