Clinical trials

Adults living with congenital heart disease (CHD) commonly experience physical symptoms alongside emotional and social challenges, which can affect wellbeing and health-related quality of life. Access to psychological services varies, and evidence to guide the development and delivery of psychological interventions for this population is still emerging. Interoceptive-based approaches focus on increasing awareness of and responding adaptively to internal bodily sensations, such as breathing, heart rate and fatigue. These approaches have shown benefits in other long-term health conditions but have not yet been studied in adults with CHD. This study will evaluate the feasibility, acceptability, and preliminary effects of a newly adapted online, skills-based group programme for adults with CHD. Thirty-two participants will be recruited through the Scottish Adult Congenital Cardiac Service and randomly allocated to one of two cohorts: Cohort 1 (Immediate Intervention) and Cohort 2 (Delayed/Waitlist Intervention). The group programme will consist of eight online sessions delivered by a Principal Clinical Psychologist and a Trainee Clinical Psychologist. Weekly sessions will explore the relationship between interoception and key areas relevant to living with CHD, including emotions, behaviours, and physical symptoms. Group discussions and exercises will focus on increasing awareness and understanding of internal bodily sensations, developing strategies for responding to interoceptive cues and using bodily information to guide behaviours and everyday activities. Participants will complete online questionnaires before and after the intervention assessing interoception, anxiety, depression and health-related quality of life. Participants will also provide feedback regarding the acceptability and perceived usefulness of the programme. Participation is voluntary, and participants may withdraw at any time without affecting their clinical care. Appropriate emotional support will be available should participants experience distress related to the group materials or discussions. Findings from this feasibility randomised controlled trial will inform further refinement of the group programme, assess the acceptability and feasibility of study procedures, provide estimates of recruitment, retention and outcome variability, and support the design and sample size calculation of a future definitive trial. The findings may also contribute to the enhancement of psychological support for adults with CHD and be disseminated through scientific publications and conference presentations.

This study aims to determine the mechanisms via which krill oil supplementation increases muscle strength and whether this translates to improvements in gait and functional characteristics in older adults. The studies we will carry out will establish, in healthy older adults, the effects of 6 months of supplementation with krill oil Objective 1) Muscle structure and function Hypothesis: Krill oil supplementation will increase muscle size and strength alongside positive changes in muscle architecture (pennation angle and fascicle length). Objective 2) Neuromuscular control and central nervous system (CNS) function Hypothesis: Krill oil supplementation will improve Neuromuscular Junction (NMJ) transmission stability and increase central drive and intramuscular coherence, as a measure of muscle synergy. Objective 3) Gait and functional characteristics Hypothesis: Krill oil supplementation will improve gait and functional characteristics.

This study will investigate how adding a specific type of dietary fat to daily meals for two weeks affects the gut bacteria and their activity. Participants will be randomly assigned to consume one of four types of fat: butter, coconut oil, olive oil, or sunflower oil (60 mL each day for 2 weeks). Stool and blood samples (after an overnight fast) will be collected at 3 time points during the study (Days 1, 7, and 22). These samples will be used to measure metabolites produced by gut bacteria, the types of bacteria present in the gut, blood lipids, and inflammatory markers. The study, based on previous in vitro findings, aims to understand whether different types of fats (based on their structure and level of saturation) have different effects on gut bacteria and their activity in healthy subjects.

This randomised crossover study's primary aim is to investigate the effect of short-term fasting (eTRE) on subjective appetite and appetite-regulatory hormones (i.e., leptin, adiponectin, total glucagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide (GIP), total peptide YY (PYY), acylated ghrelin and Insulin). In addition, to examine if the one-day early time-restricted eating influences energy expenditure and ad libitum energy intake in the periods following the standard meal test. The researchers will compare normal eating with early Time-Restricted Eating (eTRE) in healthy men.

Crohn's disease (CD) is a chronic, incurable condition associated with gut inflammation. Two important treatments currently used to manage CD are special drug injections (biologics) or a liquid-only diet using specialised milkshakes. However, treatment with biologics is only successful in approximately 55-60%. The liquid-only diet also has a better safety and effectiveness profile than traditional treatments like steroids. However, gut inflammation often returns not long after the normal diet is re-introduced, and it is difficult for patients to stick to as their sole source of nutrition for 6-8 weeks. The BIOPIC-Kids study aims to investigate whether replacing the normal diet with specialised milkshakes for 6 weeks improves response to treatment and maintenance of remission with biologics in children and young adults with CD. To achieve this, children and young adults (aged 6-18 years) with active CD commencing biologics as standard of care treatment will be randomly allocated to follow their normal diet OR replace varying amounts of their normal diet with specialised milkshakes for 6 weeks. Participants not wanting to be randomised can choose the group of their preference. Patients starting a liquid-only diet OR biologics alongside a liquid-only diet as standard of care treatment will also be recruited to compare different treatment outcomes.

The aim of this dietary intervention study is to explore how vitamin C affects the bacteria that live in our gut. Vitamins are essential nutrients found in fruits and vegetables. Our bodies cannot make them on their own, but we need them to function correctly. Vitamins play various roles, including supporting the immune system and assisting with energy production. Some vitamins in our diet can reach the large intestine, where they may be used by gut bacteria to promote their growth. In this study, we aim to investigate how our gut bacteria interact with vitamin C and how this interaction affects their growth and activity. For this study, participants will follow their habitual diet for one-week (run-in period), followed by two consecutive two-week supplementation periods in which they will first take a moderate dose (200 mg/day) and then a high-dose (1000 mg/day) of vitamin C. A final one-week period follow up period will involve a return to their habitual diet. Faecal, blood and urine samples will be collected at the start and end of each supplementation period to explore changes in gut microbiota composition, activity and markers of inflammation.

This study's primary aim is to investigate the acute effect of an exercise bout (30 minutes) on appetite and appetite-regulatory hormone responses during energy restriction. The researchers will also test if the exercise bout influences ad libitum energy intake after a period of energy restriction. The researchers will compare three groups (control, severe-energy restriction, and severe-energy restriction with exercise) to see if exercise bout, during energy restriction, affects appetite, appetite-regulatory hormones, and energy intake in healthy men.

This clinical trial's primary aim is to investigate the acute effect of two exercise bouts (short \[10 minutes\] and long \[30 minutes\]) on appetite and appetite-regulatory hormone responses to a standard meal test. The secondary aim is to investigate when the changes in appetite and appetite-regulatory hormones occur during exercise. As an exploratory aim, the researchers will test if the two exercise bouts influence ad libitum energy intake in the periods after the standard meal test. The researchers will compare three groups (control, short exercise, and prolonged exercise) to see if the exercise bouts affect appetite, appetite-regulatory hormones, and energy intake in healthy men.

This study will investigate whether beta-glucan supplementation, when added to an energy and carbohydrate-restricted diet, facilitates body weight and body fat loss, and leads to less detrimental changes in subjective appetite and gastrointestinal appetite hormones. This will be a double-blind, randomised, controlled trial in which healthy females living with overweight and obesity will be randomly assigned to a beta-glucan or a cellulose (placebo) group (1:1 basis). The randomisation software will be used to generate a randomisation list. This list will be held by a person independent of the research team. During the 4-week intervention, participants will consume an energy and carbohydrate-restricted diet combined with 9 g/day of beta-glucan (beta-glucan group) or 9 g/day of cellulose (Placebo group). During the 4-week intervention, breakfasts and dinners will consist of energy-restricted meal replacements providing 200 kcal/ meal, while lunches will be low-carbohydrate meals providing 35% of habitual energy intake. Before and at the end of the intervention, participants will conduct an experimental trial, with pre- and post-intervention trials being identical. The experimental trials will take place in the metabolic room of the New Lister Building (NLB) of the Glasgow Royal Infirmary. During the experimental trials, body weight and body composition will be measured in the fasted state, and the collection of fasting and postprandial (for the duration of 240 minutes) blood samples will be conducted. For a meal, participants will consume the low-calorie breakfast, which will be a liquid meal replacement (Cambridge Weight Plan, Corby, UK), together with 3 g of beta-glucan. Subjective appetite scores will be measured in the fasted and postprandial states. To achieve total body water and thus body composition (fat mass and fat-free mass) measurements, saliva will be collected before and 3 and 3.5 hours after consumption of D2O (which will be consumed in the fasted state). For the duration of 24 hours before the experimental trial, participants will be asked to avoid coffee and alcohol. Participants will be required to record their food and drink intake for three days before the trial days of each experimental investigation.

This randomised controlled trial will evaluate the effects of a 9-week multi-component group-based cycling programme (Cycle Nation) versus a standard single cycle training session on self-reported cycling, health and wellbeing outcomes. Participants are adults that do not regularly cycle, who will be randomly allocated to each arm of the study. Outcomes will be assessed at baseline, post-programme, and at 12 months from baseline. Cost effectiveness will be assessed, and a process evaluation will be conducted.

This study will recruit 30 adults (men and women, aged 18 years and over) who will be randomly assigned to one of two groups in a 12-week double-blind pilot trial. Participants will receive either: * Arm 1: Krill Oil group: 4 g/day of krill oil supplements (Superba™ Antarctic Krill Oil, 1000 mg capsules), or * Arm 2: Control group: 4 g/day of placebo (vegetable oil capsules). Participants will be instructed to maintain their usual diet and physical activity patterns throughout the study. Eligibility will be assessed using a health screening questionnaire, completed with the researcher's assistance, before obtaining informed consent. Habitual physical activity will be evaluated using the International Physical Activity Questionnaire (short form), and dietary intake will be assessed with the EPIC Food Frequency Questionnaire (FFQ) at both the beginning and end of the study. In addition, participants will record their fish consumption weekly using a dedicated logbook. Measurements will be taken at baseline and after 12 weeks, including: * Blood samples to assess inflammatory and metabolic markers. * Anthropometry and body composition, including weight, height, fat mass, fat percentage, and muscle mass (via ultrasound). * Muscle strength, measured using handgrip strength and maximal voluntary contraction (each performed three times with rest between attempts). * Physical performance, assessed with a 4-meter walk test at normal speed Upon completing the study, participants will receive a £50 voucher in appreciation of their contribution.

Breastfeeding is recommended for babies from birth to six months old because breast milk provides all the nutrients babies need for growth and development. Breast milk contains sugars called oligosaccharides, which support the development of a healthy gut in babies. The foods that breastfeeding mothers eat might influence the sugars in their breast milk and the natural, friendly bacteria inside their babies' gut-called the gut microbiota-which are important for overall health. Fibre-rich foods like fruits, vegetables, whole grains, beans, and nuts, as well as fermented foods like yogurt and milk kefir, support a healthy gut. The main aim of this study is to find out whether eating foods rich in fibre and fermented foods by breastfeeding mothers can affect the bacteria residing in the gut of their breastfed babies. The study will also explore how this diet affects the mother's gut microbiota, breast milk composition, and gastrointestinal (GI) symptoms for both mothers and babies. The main question of the study is: Does a 2-week diet high in fibre and fermented foods consumed by breastfeeding mothers affect the gut microbiota of their breastfed babies aged 2 to 5 months, compared to mothers following their habitual diet? Participants will: * Be randomly assigned to one of two groups: (1) one group will follow a specific diet high in fibre and fermented foods (25 g of fibre/day + 3 servings of fermented foods/day) in addition to their habitual diet, or (2) the second group will continue with their habitual diet (no specific foods will be provided) (16 g of fibre/day). * Attend a single study visit at the study location. * Provide body measurements (weight and height) of mothers and babies at the. study visit, and provide weight only during each home visit. * Complete gut health questionnaires for both mothers and babies twice during the study. * Complete two sets of 3-day, 24-hour dietary recalls during the study. * Provide stool samples (3 from babies and 2 from mothers) and 2 breast milk samples. Researchers will then compare the stool samples from both mothers and babies to see whether the specific diet makes any difference to the gut microbiota.

1\. What will happen to me if I take part? All study visits will be at the University of Glasgow main campus within the Sir James Black building. Initial visit (duration 1 hours) We will ask that for each study visit you come to the laboratory with clothing suitable to exercise in (loose shorts) for your own comfort and to also make it easier for us to complete certain measurements where access to upper legs will be necessary. Changing facilitates will be provided on-site. After the screening process, your physical activity and your diet will be assessed via questionnaires. We will then familiarise you with the physical function tests and neuromuscular measurements. Visit 2 (duration 1 hours) Before the remaining study visits in the morning, you will be asked to arrive at the laboratory after an overnight fast (no food or caffeinated/calorific beverages from 10pm), and without having done intense exercise for two days prior to the visit. Upon arriving in the laboratory, we will collect a blood sample (after which we will provide you with a snack), and measure your body composition, muscle size, muscle strength and physical function. You will then be familiarised with the resistance training protocol, and we will determine your maximum strength for two leg exercises. After these measurements are completed, we will randomly assign you to consumed 2g/day of either krill oil or a mixed vegetable oil. Visit 3 (duration 3 hours) After 8 weeks of supplementation, you will attend for a third study visit. This will involve a blood sample and repeating the same measures from the baseline visit with the addition of a measurement of soreness in the upper legs. We will then ask you to complete muscle-damaging exercises consisting of a warm-up of 5 minutes of downhill walking (5% decline at a self selected speed between 3-6 km/h) followed by 4 sets of machine exercises of both leg kicking and leg pushes. These leg exercises will be performed at \~70% of your maximum strength and we will ask you to perform as many repetitions as you can, with the last two sets of each exercise also consisting of 4 extra lowering repetitions. Five minutes and 60 minutes following the muscle-damaging exercise, all the measurements, including blood samples, will be repeated. Visit 4 (duration 1 hours) Two days after visit 3, we will once again repeat the measures taken on visit 3 for a final time. Measurements Blood sample: A blood sample (15ml) will be collected from a vein in your arm by a trained member of the research team. Muscle size: We will use an ultrasound to assess muscle thickness of one of the muscles on the outside of your legs. Muscle strength: You will sit in a chair with your legs at a 90-degree angle. A strap will be placed around the right ankle which will be connected to a force sensor and three sticky surface electrodes will be placed on your thigh. We will then ask you to contract as hard as you can with the leg fixed in position, and we will record the force for 5 seconds. You will perform 3 contractions, with a 1min rest between contractions. After the maximal contractions, will be ask you to contract at 20, 35 and 50% of your maximal effort for 15 seconds so that we can record electrical activity in your muscle. We will then stimulate a contraction with a small electrical current at rest and during a maximal contraction. We will also measure grip strength, making 3 measures from each hand. We will measure your strength on exercise machines, for both leg kicking and leg pushing. Following a warm-up, the weights on each machine will be progressively increased in until you cannot do any more. Physical function: We will ask you to rise from a chair 5 times and to walk a distance of 4 metres and record how long this takes. We will also ask you to stand for 10 seconds with your legs in 3 different positions. These will be demonstrated to you before you do this. Body composition: We will measure total fat and lean mass using bioelectrical impedance analysis. Soreness: We will ask you to mark on a line how sore your muscle feels to measure muscle soreness before and immediately after the muscle damage protocol in two different tests. In the first test, we will apply a fixed, moderate amount of pressure on your thigh and we will ask you how sore it feels; in the second test, we will apply an increasing amount of pressure until on your thigh until you tell us it feels sore.

Children with inflammatory bowel disease (IBD) including both Crohn's disease (CD) and ulcerative colitis (UC) can be at high risk of developing malnutrition due to the nature of their condition. It is also believed that some children with IBD, in need of nutritional care, are not identified quickly by their healthcare professionals. This may negatively affect their nutrition, disease progression and general well-being. Hence, it has been proposed that nutritional screening tools or scores (NSTs) should be used to promptly identify children needing further dietetic review and input. Although there are a few NSTs for generic use in sick children at hospital admission, NSTs or scores to use for children with IBD are currently missing. In this study, we would like to test the performance of an existing tool that is routinely used for all sick children at hospital admission (The Paediatric Yorkhill Malnutrition Score or PYMS)(5) and test whether PYMS can detect children with IBD who are at risk of malnutrition. If PYMS doesn't work well, we will develop a specific tool for children with IBD (The Paediatric IBD Nutrition Score or PIBD-NUTS).