Clinical trials

The gut plays an important role in supporting the immune system, and certain dietary components such as probiotics (beneficial bacteria) and prebiotics (fibres that feed beneficial bacteria) can help to maintain gut and immune health. Alginate is a natural fibre extracted from brown seaweed that is widely used in foods which may help support beneficial gut bacteria and regulate inflammation. Ongoing psychological stress is known to affect immune function and increase inflammation in the body. This study will investigate whether a daily jelly containing alginate support gut health and improve immune responses compared to a placebo in adults experiencing higher levels of chronic stress. We are recruiting participants with elevated chronic stress to assess whether a functional jelly containing alginate, can help to reduce markers of inflammation, by mediating a change in gut microbiota composition.

This clinical trial aims to explore the effect of Vitamin B6 supplementation on anxiety sensory hyperreactivity in autistic adults. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 reduce anxiety and sensory reactivity differences in autism.

People with osteoarthritis and painful joints often report poor sleep, but poor sleep can also increase pain. There have been very few studies of sleep in osteoarthritis using physical measuring devices, but in other painful conditions many people report worse sleep in questionnaires than actual sleep measured using wristwatch devices called actigraphs. This is called sleep misperception. Sleep misperception may affect the amount of pain that people report. Sleep misperception could be influenced by negative factors such as pain catastrophising (a tendency to ruminate on pain and its consequences), but also positive factors such as resilience and optimism. People who do not sleep well also have increased levels of "inflammation" in their blood (C-Reactive Protein, or CRP) and reduced pain thresholds for example to pressure or heat when tested in the laboratory. The aims of this study are to compare questionnaire and actigraphy measures of sleep in people with hip and knee osteoarthritis to see if there is sleep misperception. It is anticipated that people who report worse subjective compared to objective sleep will report more pain and have higher pain catastrophising as well as lower pain thresholds and less positive personality characteristics such as resilience. Participants will be asked to complete questionnaires about pain and sleep, mood and resilience, and to wear a wrist sleep monitoring device continuously for 7 days and nights and a brief daily sleep, pain and mood questionnaire. Willing participants will be asked to provide a pinprick of blood to measure CRP (inflammation), and Quantitative Sensory Testing (QST) for pressure pain and thermal pain thresholds using a blunt nylon filament and a heat probe on one forearm. Information from this study will be used to inform the development of a psychological intervention designed to improve resilience, sleep reporting and potentially pain.

This study aims to investigate the acute and chronic effects of 16-week probiotic supplementation (Ecologic® Barrier) on depressive symptoms and neural activity in those with mild-to-moderate depression.

This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.

This study aims to investigate the chronic effects of ETAS® on cognitive, affective and neural outcomes in healthy adults aged 60-80 years with mild to moderate subjective cognitive complaints.

In humans and most mammals, bile acids play a role in the metabolism of glucose and the transport and absorption of lipids (such as cholesterol and triglycerides), vitamins, and nutrients by allowing for emulsification (mixing) and absorption of fatty molecules that are consumed. More recently, bile acids have been discovered to influence the composition and quantity of the microorganisms in the gut microbiome. Bile acids also act as signalling molecules (like hormones) in the body, regulating important metabolic pathways and digestion. While the majority of bile acids are recycled back to the liver, a small proportion of these bile acids enter the colon and interact with the gut microbiota. Primary bile acids, synthesized in the liver, are essential for the absorption of fat- and fat-soluble vitamins, as part of the digestive process. These primary bile acids are converted to secondary bile acids by gut bacteria, which have been shown to have benefits to health. This provides the rationale for exploring the use of a bile acid, in this case 7-keto lithocholic acid (7-KLCA), as a beneficial modulator of the gut microbiome, to help regulate metabolic and potentially other disease pathways.

This study aims to investigate the postprandial (2h) and longer term (4 week) effects of a haskap berry supplement on cognitive, vascular, and metabolic function in healthy ageing adults aged 50+.

Cancer is a major health challenge, and early detection is crucial for improving patient outcomes. Research has shown that cancer can alter the way the body processes nutrients. This study aims to explore whether these metabolic changes can be detected through a simple, non-invasive method: analysing hair. Hair grows slowly over time, potentially capturing subtle metabolic changes that occur during cancer development. By studying the nitrogen stable isotope composition in hair samples donated by individuals diagnosed with cancer, we aim to identify potential early markers of the disease. Participants will be asked to donate a small strand of hair, which will be analysed using a laboratory technique called Isotope Ratio Mass Spectrometry (IRMS). The findings from this study could contribute to new, non-invasive screening tools for early cancer detection.

This study aims to investigate the effect of a breakfast meal containing varying serving sizes (doses) of pistachio nuts on cognitive function throughout the course of the day in healthy ageing adults aged 65-80.

The goal of this clinical trial is to test if coffee consumed as a tablet is biologically equivalent to that consumed traditionally as a drink. It will also learn about the impact of the short-term intake of coffee on markers of cardiovascular and liver health. The main questions it aims to answer are: * Do coffee bioactive compounds produce the same levels in blood and urine regardless of how the coffee is consumed (tablet or drink)? * How does coffee as a tablet or drink impact cardiovascular risk and liver health versus a non-coffee control? Participants will: * Visit the clinical unit for three phases; each phase is 1x 480 minute (eight hour) acute postprandial visit and 1 x one hour visit the following day. During each phase they will be randomly assigned to take a different intervention (coffee drink, coffee tablet, coffee-free control) * Be cannulated during the 480 minute (8 hour) acute visits and have regular blood draws as well as basic clinical assessments * Return on day two for a fasting blood sample and basic clinical assessment * Collect their urine for 24 h * Be asked to record their intake of foods and drinks for 3 days to assess their usual diet (dietary assessment).

A diet high in flavonoids is becoming more established as beneficial to human health. Recent data suggest that the regular consumption of flavanols can reduce the numbers of deaths by cardiovascular disease at a population level. The mechanisms for these reductions in deaths by cardiovascular disease are still debated and little is known about their impacts on factors affecting blood viscosity. The metabolism of flavanols is complex, with different metabolites being predominant in the blood at different time points. Therefore, in this study, we will investigate the effects of green tea, a well-known source of flavanols, on blood viscosity at different time points. This will be assessed in healthy individuals with no history of cardiovascular disease aged 65+ years old. Blood viscosity will be measured before, and 2hours and 8hours after the consumption of green tea.

The goal of this study is to investigate whether a seaweed derived food additive, carrageenan, has an impact on the human gut microbiome in vivo. The primary purpose is to assess whether consumption of a carrageenan containing product for 4 weeks can alter the bacterial composition of the gut microbiome in healthy individuals and whether the addition of a prebiotic fibre, inulin, to the product has an enhanced beneficial impact of the gut composition. The main questions to answer are: Does the consumption of a confectionary item containing carrageenan and inulin lead to a positive impact on the faecal microbial community when compared to the confectionary item containing no carrageenan and no inulin (placebo)? Participants will be asked to consume 2 gummy sweets for 4 week period and provide stool and urine samples on 3 occasions over a 9 week period. Does the consumption of a confectionary item containing carrageenan and inulin improve gastrointestinal comfort measured using overall SHS-GI score when compared to baseline measurements recorded during run in period?

The goal of this cross-sectional study is to investigate the health benefits of the Menus of Change in undergraduate university students, by comparing 2 groups: Students eating in the Menus of change catered halls, versus students eating outside the Menus of change meal plan. The main question it aims to answer is: What are the effects of the menus of change on other vascular outcomes, namely blood pressure? What are the effects of the menus of change on other health markers?

High levels of animal proteins (meat) in the diet are linked with a greater risk of developing heart disease and other long-term health conditions. Recently there has been a shift to plant-based diets including plant proteins such as pulses, defined as beans, peas, chickpeas and lentils. Pulses are a nutritious and sustainable form of plant protein which are rich in fibre and iron. Despite this, the UK population does not consume the recommended daily amount of pulses (80g/day equivalent to a large handful). In contrast, bread is commonly consumed but very little is known about how bread enriched with pulses influences the amount of iron that is digested and absorbed by the body as well as risk factors for developing heart disease and type 2 diabetes. The main purpose of this randomised controlled cross-over study is to determine how consuming bread enriched with pulses (in the form of faba bean flour at approximately 40% enrichment) compared with conventional white bread (100% wheat flour) influences the amount of iron absorbed in healthy males and females aged 18-50 years with low iron stores. Secondary aims are determining the effects on blood fats and sugar (glucose) and on feelings of fullness (also known as satiety) after eating the bread enriched in pulses and conventional white bread. Participants will be required: * To attend for seven study visits over a period of 60 days. * Consume a breakfast meal containing either the faba bean-enriched bread or conventional bread over two study periods, each consisting of one 7 hour study visit and two consecutive visits of 2 hours in duration. After 28 days, participants will return for the second study period as above, with a final study visit conducted 28 days later. * Give blood samples during 2 x 7 hour study visits * Complete visual analogue scales to rate appetite after consuming the faba bean-enriched and conventional white bread. * Record dietary intake prior to and during the study period.

Cognitive (brain) function, especially memory, gradually declines during ageing, which may in part be caused by an increase in systemic inflammation as well as a reduction in vascular functions and cerebral blood flow. Blood inflammatory mediators such as c-reactive protein (CRP) and interleukin-6 (IL-6) found to be significantly higher among people over 65 years compared to younger age groups. Anthocyanins is water-soluble compounds giving blue, purple and red colours in fruits and vegetables. Anthocyanins have been demonstrated to improve cognitive function, inhibit inflammation, and protect cardiovascular health. Black rice contains high amounts of anthocyanins mainly cyanidin 3-glucoside and peonidin 3-glucoside as well as various nutritional compounds such as carbohydrate, vitamin B, vitamin E and fibre. Previous studies reported health benefits of black rice, including anti-inflammation, antioxidative stress, anti-diabetes, and improved cognitive function. However, the effect of black rice consumption on cognitive function related to inflammation has not been studied in humans. Therefore, this study aims evaluate the acute \& short-term effects of black rice consumption on the cognitive function, inflammation, and vascular function in older adults aged 50-80 years. The primary and secondary research questions of this study will address: 1. Do the acute and short-term anthocyanin-rich black rice intakes improve cognitive function in older adults aged 50-80 years? 2. Do the acute and short-term anthocyanin-rich black rice intakes modulate inflammatory status and microvascular function in older adults aged 50-80 years?

Gut microbiota produce different metabolites within the human body, which include neurotransmitters. Animal studies have demonstrated a critical role for the gut microbiota in various aspects of brain and behavioural function, and a smaller number of studies in humans have shown differences of gut microbiota composition in psychiatric conditions. However, almost nothing is known about the impact of neurotransmitters produced by the gut microbiota on human brain and behaviour. The way in which differences in brain, behaviour and personality traits are associated with the gut microbiota, and how they are influenced by a probiotic will be explored, with a special focus on GABA (Gamma Amino Butyric Acid). Abnormalities of microbiota composition have been identified in metabolic disorders, such as inflammatory bowel disease and obesity, and psychiatric conditions, such as depression and anxiety. The aim of this intervention trial will be to answer the following fundamental questions: 1. Does the population of gut bacteria capable of producing GABA modulate brain-based measures of GABA? 2. Does the population of gut bacteria capable of producing GABA influence performance in behavioural tasks known to depend on GABA-ergic function? The impact of a GABA producing probiotic on the measures of GABA in the brain and serum, relevant metabolites in blood, faecal and urine samples and performance in GABA dependent behavioural tasks will be investigated in this trial.