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NCT ID: NCT05016557 Completed - Muscle Metabolism Clinical Trials

The Muscle Protein Synthetic Response of Algal and Fungal Protein

SCAM
Start date: December 19, 2020
Phase: N/A
Study type: Interventional

Dietary protein intake is vital for the maintenance of skeletal muscle mass and health. The production of animal-based proteins sources is associated with growing environmental and ethical challenges. As such, sustainable alternatives are needed. Algae are sustainably produced high-protein sources and it is predicted that algae will become one of the most consumed proteins in the next decades. However, the effects of algae on the stimulation of muscle mass growth are unknown. Therefore, we aim to assess the rate of digestion and absorption, and the effects on muscle growth of two types of algae (spirulina and chlorella) when compared to a sustainable non-animal derived fungal reference protein (mycoprotein), a source known to elicit a robust anabolic response.

NCT ID: NCT05016375 Completed - Type 2 Diabetes Clinical Trials

Perceptions of Passive Heating in Individuals With T2DM

Start date: June 28, 2022
Phase:
Study type: Observational

Current treatments for type 2 diabetes (e.g., lifestyle changes and clinical interventions such as medication), have been shown to be unsustainable due to low levels of physical activity and increasing clinical costs. Therefore, scientists have been looking for new treatments to address this issue. One such treatment that is being investigated is passive heating (e.g., hot baths, saunas, etc.). In this study the investigators want to ascertain what passive heating, if any, individuals with T2DM currently do, what their perceptions of passive heating would be if it were to become a treatment, what may make it easier or more difficult for them to engage in passive heating, and how this might impact other areas of their life such as physical activity.

NCT ID: NCT05013398 Completed - Clinical trials for Psychological Distress

The Together Webinar Programme For Military Partners

TTP-Webinar
Start date: May 7, 2019
Phase: N/A
Study type: Interventional

Military partners are at risk of mental health difficulties, including depression, anxiety and secondary traumatization. However, many partners face a range of barriers in accessing psychological support. As such, there remains a need to investigate how to make support for military partners more accessible. The present study was a pilot randomized controlled trial (RCT) investigating the effectiveness of The Together Webinar Programme (TTP-Webinar) in reducing psychological distress and secondary trauma symptoms and improving quality of life among partners of veterans with PTSD and other mental health difficulties. The pilot RCT compared the TTP-Webinar intervention to a waitlist condition. The primary aim was to assess the acceptability and feasibility of offering web-based support to military partners and to investigate the efficacy of the remote-access support. It was hypothesized that, compared to the waitlist condition, the TTP-Webinar would result in significant reductions in psychological distress and secondary symptoms, and improvements in overall quality of life.

NCT ID: NCT05013359 Completed - Obesity Clinical Trials

Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)

ACTION Teens
Start date: August 23, 2021
Phase:
Study type: Observational

ACTION Teens is a multinational cross-sectional survey-based study. The study consists of a quantitative online survey to be conducted among three groups of respondents in ten countries worldwide. The respondent population will include Adolescents Living with Obesity (ALwO), Caregivers of ALwO, and HCPs treating adolescents who have obesity. The goal of this study is to provide insights to drive awareness around the needs of adolescents living with obesity and their caregivers, as well as to identify key areas of misalignment between adolescents, their caregivers and the HCPs involved in obesity treatment and management. ACTION Teens is designed to generate evidence to identify and address these challenges on both a global and local level, extending the insights from the previously conducted ACTION-IO study.

NCT ID: NCT05012722 Completed - Arterial Stiffness Clinical Trials

Arterial Stiffness in Heart Failure and Chronic Kidney Disease

ASHFCKD
Start date: January 30, 2022
Phase:
Study type: Observational

This observational study is assessing the effects that arterial stiffness may have on patients with heart failure (HF) and chronic kidney disease (CKD). Arterial stiffness will be measured by assessing pulse wave velocity (PWV). Carotid- Femoral PWV is the gold standard in measuring arterial stiffness non- invasively. Many studies have shown increasing PWV is a predictor of cardiovascular events, but the significance of increasing PWV as a surrogate marker for the potential worsening (decompensation) of HF or CKD has not been explored. This study aims to investigate patients with HF and CKD by assessing PWV while in a decompensated state and again when in a stable condition after 4 weeks of discharge to investigate a link between decompensation and rise of arterial stiffness. The research team aim to recruit 120 patients in this study with 40 patients in each of the 3 groups- heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF) and acute kidney injury (AKI). All AKI patients would have had known CKD (stages 3a, 3b or 4). The study participants will be initially recruited in hospital while admitted in an acute state and tests including bloods, ECG, echocardiography and PWV will be performed. The tests (excluding echocardiography) will be repeated 4 weeks after discharge. There is no intervention in this study. The study seeks to improve the understanding of the role of the vasculature in the development of acute HF in the two common types- HFrEF and HFpEF. As CKD is a common comorbidity in heart failure patients we felt that a study of the behaviour of arterial stiffness in this cohort will add to this understanding. If arterial stiffness is found to be an important component of the HF syndrome therapeutic interest could be focused at managing arterial stiffness with novel therapy.

NCT ID: NCT05012670 Completed - Healthy Clinical Trials

Mass Balance Recovery, Metabolite Profile, and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects

Start date: August 18, 2021
Phase: Phase 1
Study type: Interventional

Single-centre, open-label, non-randomised study to assess the mass balance recovery, PK, metabolite profile, and metabolite identification of a single oral dose of 14C labelled paxalisib ([14C] Paxalisib) in healthy male subjects.

NCT ID: NCT05011773 Completed - Parkinson Disease Clinical Trials

Manipulating and Optimising Brain Rhythms for Enhancement of Sleep

MORPHEUS
Start date: August 3, 2021
Phase: N/A
Study type: Interventional

Treatment of sleep disturbances is mainly attempted through drug administration. However, certain drugs are associated with unwanted side effects or residual effects upon awakening (e.g. sleepiness, ataxia) which can increase the risks of falls and fractures. In addition, there can be systemic consequences of long-term use. An alternative method of manipulating sleep is by stimulating the brain to influence the electroencephalogram (EEG). To date, there have been mixed results from stimulating superficial areas of the brain and, as far as we know, there has been no systematic attempt to influence deep brain activity. Many patients suffering from movement disorders, such as Parkinson's Disease (PD) and Multiple Systems Atrophy (MSA), also have disrupted sleep. Currently, at stages where drug treatment no longer offers adequate control of their motor symptoms, these patients are implanted with a deep brain stimulation system. This involves depth electrodes which deliver constant pulse stimulation to the targeted area. A similar system is used in patients with severe epilepsy, as well as some patients with chronic pain. The aim of this feasibility study is to investigate whether we can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep. We will only use stimulation frequencies that have been proven to be safe for patients and frequently used for clinical treatment of their disorder. We will examine the structure and quality of sleep as well as how alert patients are when they wake up, while also monitoring physiological markers such as heart rate and blood pressure. Upon awakening, we will ask the patients to provide their subjective opinion of their sleep and complete some simple tests to see how alert they are compared to baseline condition which would be either stimulation at the standard clinical setting or no stimulation. We hope that our study will open new ways of optimising sleep without the use of drugs, in patients who are implanted with depth electrodes. We also believe that our findings will broaden the understanding of how the activity of deep brain areas influences sleep and alertness.

NCT ID: NCT05011370 Completed - Clinical trials for Intestinal Failure-associated Liver Disease

Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition

THRIVE-1
Start date: August 23, 2021
Phase:
Study type: Observational

This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week. Liver disease will be determined by the presence of choline deficiency, cholestasis (confirmed by elevated serum alkaline phosphatase (ALP) liver isoenzyme level), and steatosis (confirmed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF). The objective of this study is to investigate the presence/prevalence of liver disease in patients dependent on PN (≥4 days a week).

NCT ID: NCT05010057 Completed - Muscle Damage Clinical Trials

The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Recovery Following Strenuous Exercise

CurraNZ_MD
Start date: June 10, 2016
Phase: N/A
Study type: Interventional

The study aims to examine the effect of a New Zealand blackcurrant (NZBC) supplement on markers of muscle damage and recovery following strenuous resistance exercise. The investigation will compare responses between an experimental (NZBC capsule, 300 mg/day) and placebo (PLA capsule, 300 mg sugar) group. Participants will attend a screening session where they will consent to the study, complete a pre-activity medical questionnaire and have their height, weight and resting blood pressure measured. If the participants meet the inclusion criteria they will perform a familarisation session on the muscle strength assessment. Participants will be randomized to NZBC or placebo groups, and consume one capsule in the morning (between 6-10 am) for 12 days. This is a double-blinded study, which means that the participant and the study team will not know which group the participants are assigned to until the study is over. On day 8 participants will perform a strenuous bout of upper body resistance exercise on the isokinetic dynamometer (exercise device). Muscle strength and soreness, arm circumference, and elbow range of motion will be measured, and a fasted blood sample will be collected, before and 24, 48, 72 & 96 hours after the muscle fatigue protocol (on days 9, 10, 11 & 12). A marker of muscle damage (creatine kinase [CK] concentration) will be measured in the blood samples. Participants will also be asked to complete a 6-day dietary record, beginning on day 7 and ending on the final day of testing (day 12).

NCT ID: NCT05007678 Completed - COVID-19 Clinical Trials

Targeting de Novo Pyrimidine Biosynthesis by Leflunomide for the Treatment of COVID-19 Virus Disease

DEFEAT-COVID
Start date: September 16, 2020
Phase: Phase 3
Study type: Interventional

The global COVID-19 pandemic has caused unprecedented strain on health care services around the world.The absence of specific anti-viral medications to treat the underlying infection led to a proliferation of clinical studies and trials aimed at re-purposing existing medications. Human dihydroorotate dehydrogenase (DHODH) is vital enzyme utilised by viruses to replicate in the host cell. Leflunomide, a drug that is already licenced to treat rheumatoid arthritis, is a potent inhibitor of the enzyme DHODH. Importantly, this drug has dual anti-viral and anti-inflammatory properties so it targets viral replication and suppresses host inflammatory response which plays a role at more progressive stages of infection. DEFEAT-COVID is a multi-site, international, interventional, pragmatic, parallel group design, open label, randomised CTIMP with a pilot phase that will allow to adapt procedures and assessments if required. A phase III clinical trial of leflunomide for treating COVID-19 has been registered in China, Registration number: ChiCTR2000030058). The current proposal extends the original clinical study of leflunomide in China (People's Hospital of Wuhan University) to the UK through a structured collaboration.