Clinical trials

Perimenopause is when you have symptoms of menopause but your periods have not stopped. Brain-related changes are just one of the many symptoms that occur, and changes to memory and concentration ("brain fog") are frequently reported to be a challenge to those experiencing them. Diet is also understood to play an important role during menopause, however there is still more to learn about the direct impact of nutrition on brain-related symptoms associated with perimenopause. The aim of this research is to identify mental tasks capable of capturing perimenopause-related changes and to better understand how diet might account for differences in mental task performance.

Perimenopause is a stage of transition into menopause that is marked by menopausal symptoms while menstruation is still taking place. Perimenopause symptoms include mood changes, anxiety, sleep disruptions, hot flushes, night sweats, fatigue, and cognitive challenges. The frequency and severity of these symptoms can seriously impair women's quality of life. Even if the public's awareness on menopause has increased, there are still a lot of unanswered questions. A connection between nutrition and menopause management has been proposed in earlier research. However, there is limited research in this field, and women frequently turn to social media for supplement recommendations in order to deal with menopause-related issues. Vitamins and minerals such as vitamin D and calcium are recommended by the European Menopause and Andropause Society and there is limited evidence to suggests that soy and herbals may have a beneficial effect on menopausal symptoms, but more research is needed. The aim of this study is to investigate the effects of 12-weeks multi-vitamin/mineral and herbal extract-containing supplement on menopause symptoms, memory and concentration, sleep, and psychological well-being.

Perimenopause is a transition phase into menopause, characterised by menopausal symptoms while menstrual periods are still occurring. Common symptoms of perimenopause include hot flushes, night sweats, mood swings, anxiety, sleep disturbances, fatigue, and cognitive difficulties. These symptoms can be both frequent and intense, with the potential to significantly deteriorate women's quality of life. Despite an increase in public discourse around menopause, there are still large gaps in knowledge. Previous literature has suggested a relationship between diet and menopause management. However, studies in this area are limited and women often rely on social media for advice on supplements to address menopause complaints. One supplement that has received a lot of attention with purported benefits for menopause is magnesium, primarily due to its links to energy and or/sleep, however no studies have explored psychological effects of magnesium supplementation in perimenopause. The aim of this study is to explore the effects of 12-weeks magnesium supplementation on perimenopause symptoms, cognition, sleep, and psychological well-being.

Introduction Parkinson's disease (PD) limits mobility by worsening gait/walking and increasing fall risk. Falls lead to injuries and reduce confidence in performing everyday tasks. That lowers a person's ability to participate in community activities such as going to the shops or visiting friends, which reduces their quality of life. Development of interventions for gait impairments and falls is a research priority for Parkinson's UK. Understanding gait Traditionally, one approach a physiotherapist may use to try and improve/retrain a person's gait is with an electronic metronome which is a device that "beeps" nearly every second. The physiotherapist sets the metronome beeping, and the person tries to step to each beep. However, success depends on the physio's expertise/experience. Regardless, beeping sounds are described as boring. Smartphone app An app may be the solution. Smartphones have many sensors, meaning they can accurately measure gait but also deliver retraining via music. That is possible by the creation of an "app" that can be downloaded and installed on anyone's smartphone. Research proposal The investigators have developed and validated an app (CuePD) that uses music for gait retraining, to make it more enjoyable by having people listen to their preferred music. The aim for this study is to get people with PD (PwPD) using CuePD in their home and when out walking for 12-weeks to determine: (i) how PwPD use and value CuePD and (ii) CuePD's ability to improve gait to reduce fall risk.

The goal of this experimental study is to examine the influence of Lemongrass extract on aerobic training parameters following a 6-week training programme in males. A secondary aim will be to explore the influence on sexual wellness. Participants will attend 23 visits to the laboratory involving: * fitness testing (some to exhaustion). * blood sampling (capillary and venous samples). * a supervised 6 week high-intensity interval training (HIIT) programme. * consuming either the lemongrass extract or placebo in the form of tablets, once a day during the 6 week training.

Introduction Cardiovascular disease (CVD) remains the leading cause of mortality worldwide, with arterial hypertension representing the most significant modifiable risk factor (Lim et al., 2012; Mills et al., 2020). While clinical manifestations of arterial hypertension typically emerge in later life, the underlying pathophysiological mechanisms, particularly autonomic dysfunction, begin decades earlier. Autonomic imbalance, characterised by sympathetic overactivity and diminished parasympathetic tone, not only precedes sustained arterial hypertension but also independently predicts future cardiovascular risk, even in normotensive individuals (He et al., 2023; Thayer et al., 2010). Reduced heart rate variability (HRV), a non-invasive marker of parasympathetic activity, has been consistently associated with increased cardiovascular morbidity across diverse populations (Task Force, 1996). Critically, young apparently healthy adults with suboptimal lifestyle factors, including physical inactivity, poor dietary habits, and chronic stress, frequently exhibit reduced HRV and altered sympathovagal balance (Liao et al., 1998). These subclinical autonomic changes represent an early, potentially reversible stage in the cardiovascular disease continuum, suggesting that interventions targeting autonomic balance may prevent or delay progression to overt disease (Goldstein et al., 2011). The vagus nerve, the main parasympathetic pathway, exerts multiple cardioprotective effects, including heart rate deceleration, baroreflex enhancement, reduced vascular tone, and anti-inflammatory activity (Thayer \& Sternberg, 2006). Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a non-invasive method to enhance vagal activity by delivering electrical stimulation to the auricular branch of the vagus nerve via surface electrodes placed on the tragus or cymba conchae (Badran et al., 2018). Neuroimaging studies confirm that taVNS activates central vagal projections, including the nucleus tractus solitarius, the primary relay station for cardiovascular autonomic control (Frangos et al., 2015). Preliminary research demonstrates that acute taVNS sessions increase HRV, enhance baroreflex sensitivity, and reduce sympathetic vascular tone in healthy adults (Clancy et al., 2014; De Couck et al., 2017), while emerging evidence suggests clinically meaningful reductions in blood pressure (BP) in hypertensive patients (Mbikyo et al., 2024). Despite these promising findings, significant knowledge gaps remain. Most studies have examined clinical populations with pre-existing autonomic abnormalities, making it difficult to isolate primary taVNS mechanisms from disease-related compensatory responses. Additionally, chronic intervention protocols preclude detailed characterisation of immediate autonomic and hemodynamic changes. Conducting mechanistic studies in healthy populations offers critical advantages: absence of confounding medications and disease adaptations enables clearer identification of taVNS-induced autonomic and hemodynamic changes, while establishing baseline response patterns provides an essential reference framework for interpreting clinical population responses and informing preventive interventions. Investigation of acute responses permits precise temporal mapping of physiological changes, distinguishing primary mechanisms from downstream consequences, enables efficient optimisation of stimulation parameters, and provides biological plausibility for chronic effects while identifying potential responders to therapy. Therefore, this study proposes a randomised, sham-controlled crossover study to systematically characterise acute cardiovascular and autonomic responses to a single 60-minute taVNS session in healthy young adults. Using continuous non-invasive BP monitoring and detailed HRV analysis, this study will establish whether taVNS produces acute, measurable changes in BP, heart rate, and autonomic balance in individuals with normal baseline function. We will elucidate the temporal dynamics of taVNS-induced effects, characterise the mechanistic pathways distinguishing cardiac, hemodynamic, and autonomic contributions, and evaluate the specificity of active stimulation versus sham conditions. By establishing baseline physiological response patterns and elucidating acute mechanisms in a well-controlled population, our findings will lay the groundwork for subsequent investigations in at-risk and hypertensive individuals, ultimately contributing to evidence-based, personalised autonomic modulation therapy for cardiovascular disease prevention and management.

This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.

The main objective of this observational trial is to explore the validity and reliability of DANU smart socks when used for mobility assessments in people with Parkinson's. Using a series of laboratory gold standard equipment, this project aims to compare the metrics observed by DANU to the reference standards. No intervention is included. Specifically, this study will explore metrics relating to walking (gait) and balance of a Parkinson's cohort through a series of motor tasks. Moreover, this study seeks to investigate the clinical validity of DANU outcome metrics exploring relationships with clinical scales, fall history and prospective falls.

This observational study aims to explore the use of the DANU Smart Socks for gait and balance assessment in people with Parkinson's (PwP). The study will compare walking and balance outcomes produced by DANU from people with Parkinson's (PwP) and a group of healthy individuals of similar age. The project aims to investigate if the gait and balance data collected are linked to measures of Parkinson's symptoms such as disease progression and cognitive abilities. Gait and balance outcomes will be obtained through one observational laboratory visit.

High blood pressure (hypertension) is a leading risk factor for cardiovascular diseases and may contribute to poor health and premature death. The purpose of this research is to learn if a home-based isometric exercise programme combined with lifestyle change advice is a practical and acceptable method for people diagnosed with hypertension to manage their condition. Isometric exercise involves a muscle contraction without movement of the limbs and previous research has shown this may be effective for reducing blood pressure. Therefore, this study will explore the experiences, thoughts, attitudes, and barriers to participation. It will also examine the effect the isometric exercise has on blood pressure. Participants will undertake an isometric exercise programme using a wall squat position, 3 times per week, for 12 weeks. The exercise sessions will be completed at home with remote online supervision by an exercise professional. Lifestyle change advice will given in line with current guidelines to promote healthy behaviours to reduce high blood pressure. After 12 weeks, participants will be encouraged to continue with the wall squat exercise for a further 12-weeks unsupervised. Throughout the study, participants' blood pressure and daily activity will be recorded using a smartwatch device. Upon completion of the intervention period, participants will be interviewed to gather their views and opinions on the isometric exercise programme. Changes in blood pressure will be evaluated at 12 and 24 weeks. By exploring whether an isometric exercise programme is a feasible and acceptable method for hypertensive people to manage their condition and how this influences blood pressure, this research may aid in the development of a strategy to manage hypertension.

Getting an accurate blood pressure (BP) reading is essential for diagnosing high blood pressure and managing it effectively. High blood pressure is a major health problem, causing about 9.4 million deaths worldwide each year. More people need to monitor their BP at home, so there is greater demand for easy-to-use devices. Traditional BP monitors with arm cuffs can be bulky, uncomfortable, and awkward to use. Modern technology has made it possible to measure BP using wearable devices like smartwatches. HUAWEI has developed a wrist watch that can measure BP and has been tested to meet international standards. The watch passed these tests and was approved for people to use at home to check their own BP. However, the HUAWEI watch was only tested on people in China and the investigators need to know if it works for people from other countries and ethnic backgrounds.

The goal of this clinical trial is to learn if a Nepalese Pepper Extract (Zanthoxlum Armatum, ZA) supplement can improve cognitive performance and mental abilities in competitive gamers aged 16 to 34. The main questions it aims to answer are: 1. Does ZA supplement improve cognitive abilities like attention, memory, and decision-making? 2. What is the most effective dose of ZA supplement (300mg vs 150mg)? 3. How do the effects of ZA supplement compare to caffeine? Researchers will compare four different treatments (high-dose ZA, low-dose ZA, caffeine, and placebo) to see if ZA supplement produces better cognitive performance than placebo and how it compares to caffeine\*\*. Participants will: * Complete a screening visit with health checks and training on computer tasks * Attend four testing visits (7-14 days apart) where they receive different treatments * Avoid alcohol and energy drinks for 24 hours before each visit, and caffeine from waking * Take assigned treatment at 11:30am and complete cognitive tests at -1, 1, 3, and 5 hours in relation to dose. * Complete mood questionnaires, sleep assessments, and gaming-specific tasks (aim training, character control) * Wear heart rate monitors during testing * Eat standardized meals provided during visits * Play competitive games at home in the evening and complete performance questionnaires

The aim of the study is to investigate the acute and chronic effects of a supplement containing Caffeine, Vitamins, Minerals and Botanical extracts on cognitive function, sleep and wellbeing, in healthy volunteers. The study will follow a randomised, double-blind, placebo-controlled, crossover design. Participants will receive both treatments, and both study arms will include an acute testing visit (day 1) and a chronic testing visit (day 29). The active treatment contains a blend of 120mg caffeine, vitamins, minerals and botanical extracts and the matched placebo treatment contains marigold extract and brown rice flour. The trial will use computerised cognitive tasks, administered via COMPASS software (Northumbria University, UK), online cognitive assessments via Cognimapp and self-reported questionnaires and sleep diary, as measures of the outcome variables. 90 participants will participate, aged 18-75, and self-ported as being in good health. Participants will be randomly allocated to a treatment order and will be supplied with either the active treatment or the placebo whilst visiting the research centre for the acute testing visits. Participants will take the treatment home to consume daily for the duration of the supplementation period. Participants will record the time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, at each chronic testing visit.

The aim of the study is to investigate the effects of 6- and 12- week supplementation of a bioactive whey protein concentrate drink containing dairy phospholipids on sleep and daytime function parameters in healthy adults. The proposed randomised, double-blind, placebo-controlled parallel groups design methodology will assess the sleep and daytime function effects (both self-reported and physiological) of 40g per day of bioactive whey protein concentrate in the form of a powder that the participant will be required to mix with 350ml of water and matched placebo prior to (baseline) and after -6 week and -12 week supplementation. The trial will utilise actigraphy sleep watches and online cognitive assessments alongside saliva sampling, sleep diaries, and self-report questionnaires as measures of the outcome variables. 70 participants will participate, aged 25-49, and self-reported as being in good health. Participants will be supplied with either the active treatment or the placebo (allocated by a randomised schedule) whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study. Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, upon completion of the study.

Multimorbidity (the presence of two or more coexisting long-term conditions) is a significant challenge facing the NHS, especially given UK's ageing population and the association with high levels of illness burden and healthcare costs. Over 50% of adults \>65 years have multiple long-term conditions (MLTCs). Our group has validated a broad range of algorithms applied to single wearable sensors that have the potential to capture walking-related mobility outcomes (such as walking cadence and walking speed) accurately and reliably during activities of daily living across five single long-term conditions. These algorithms, however, cannot be readily applied to people with MLTCs because the effect of multimorbidity on mobility is amplified compared to single long-term conditions secondary to a greater number of complications and sequelae. Accordingly, the aim of this study is to validate algorithms that would allow robust estimation of walking-related mobility outcomes during daily life activities in MLTCs. To meet our objectives, the investigators will perform: i) laboratory-based technical validation of existing and newly developed algorithms for walking-related mobility outcome detection; ii) unsupervised real-life validation of selected algorithms; and iii) examination of how well the validated walking-related mobility outcomes reflect global and disease specific characteristics in older adults with multimorbidity. The investigators will adopt an integrated patient-centric approach where patients with MLTCs will be engaged early in the project to provide input of their perception and concerns regarding mobility limitation in daily life activities. The investigators aim to recruit 55 older adults (\>65 years), men and women, with multiple long-term conditions with the following inclusion criteria: having two or more of the following conditions including osteoarthritis, rheumatoid arthritis, osteoporosis, type 2 diabetes, depression and/or anxiety, hypertension, coronary heart disease, heart failure, atrial fibrillation, chronic obstructive pulmonary disease, asthma, bronchiectasis, chronic kidney disease, cancer, or stroke within the last 5 years.

Falls and broken bones are a common health problem faced by older adults. Worldwide, one third of adults aged over 65 years old, and half of adults aged over 80 years, fall each year. One in five falls in older adults result in hospitalisation and one in twenty cause broken bones. Each year, 300,000 older adults break a bone following a fall which costs the UK £4.4billion in healthcare costs. Broken hip bones are the most serious outcome of a fall. One in twenty older adults will die and one in five need care assisted living following a hip fracture. Muscles and bones become weaker after 50 years of age which increases an older adults' risk of falling and breaking a bone. Falls prevention programmes that include muscle strength and balance exercise improves physical function and helps to prevent falls and broken bones in older adults. However, many older adults stop doing exercise and become less physically active after falls prevention programmes end. Gains in balance and muscle strength are lost and falls risk increase if people don't keep exercising. More people are reaching older ages and becoming less active. Therefore, this problem will worsen unless healthcare practices become better at preventing falls and broken bones in older adults. The research ambition is to create a technology supported home exercise programme that encourages older adults to keep exercising after falls prevention programmes end. This will help to prevent future falls and broken bones which will allow more older adults to continue living independently. The home exercise programme will benefit older adults everyday lives by helping them to maintain good physical health and improve their ability to perform daily tasks without the fear of falling. Older people at risk of falls, clinicians, and public members will be invited to form a research advisory group. The group will work with the research team to create the home exercise programme and research plan and advise how best to communicate the research to the public. Diversity within the research advisory group will be important to help shape the research to meet the diverse views and needs of the many different people affected by falls and broken bones. We will target the research to help older adults with the greatest health needs. Older adults living in deprived neighbourhoods have the greatest risk of falling and dying following a broken bone. The home exercise programme will be researched in older adults attending falls prevention programmes in the most deprived regions of England. This will help us to explore whether the programme could encourage the continuation of exercise in older adults who need it most.