View clinical trials related to Inflammation.
Filter by:In Romania, the diseases of the circulatory system account for 59.3% of deaths, representing the main cause of morbidity and mortality. Barriers of current pharmacological treatments materialized in side effects and limited actions on risk factors increase the necessity of finding more effective, multi-target and less toxic therapeutic strategies. Considering the well-known benefits, natural compounds represent a very important source for drug candidates. The latest in vitro and in vivo studies on Aronia melanocarpa (Michx.) Elliott have highlighted its antioxidant, anti-inflammatory, anti-proliferative, anti-atherosclerotic, hypotensive, antiplatelet, lipid and glucose reduction properties, making it an excellent candidate for the prevention and treatment of cardiovascular and metabolic disorders. The aim of this study is to comprehensive evaluate (in vivo) the Aronia melanocarpa bio juice, obtained from Romania on blood pressure levels and endothelial damage.
Multiple sclerosis (MS) is a chronic, immune-mediated, demyelinating disease of the central nervous system. Typical brain lesions of the disease may be partially repaired by an endogenous remyelination process which is limited and tends to deplete over the course of the disease. Cladribine tablets are an approved treatment that promotes selective lymphocyte depletion, reducing the inflammatory activity of the disease. The present study is based on the hypothesis that improved inflammatory control through cladribine tablets provides a tissue microenvironment more favorable for remyelination of brain lesions in MS. This hypothesis will be evaluated by a single-arm, open-label, phase IV, single-center, proof-of-concept clinical trial in which 10 participants with relapsing-remitting, highly active MS, relatively early in the course of the disease, will receive conventional treatment with cladribine tablets and will be followed-up for 48 months. Neurological, neuropsychological and magnetic resonance imaging (MRI) parameters will be measured. Remyelination will be assessed by a novel MRI technique called the q-Space myelin map. Additionally, the peripheral blood lymphocyte and cytokine profiles will be evaluated in order to understand the immunological aspects that influence the remyelination capacity in patients treated with cladribine tablets. The study will be conducted in accordance with current regulations governing clinical research in Brazil.
This study is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, parallel-group, single-centre clinical trial investigating the body weight loss potential of dapiglutide, a dual GLP-1R/GLP-2R agonist, administered subcutaneously once weekly. The study will investigate the efficacy of once-weekly subcutaneously administered of 4 mg and 6 mg dapiglutide versus placebo in 54 obese individuals (BMI >30 kg/m2) during a 12-week treatment period.
The goal of this randomized wait-list clinical trial is to test in patient facing Mexican healthcare providers the efficacy of the Integrated Toolbox for Healthcare Providers (ISTH) on psychological functioning, well-being, occupational performance, and peripheral inflammation. The main questions this study aims to answer are: - Does assignment to the ISTH predict reduced psychological distress and increased well-being? - Does assignment to the ISTH predict improved occupational outcomes and social-emotional competencies? Participants will be randomly assigned to either the ISTH, a 12-week synchronous and app-based well-being training or to a wait-list control condition and complete assessments 8 times over the nine-month study period. Researchers will compare the ISTH and the wait-list control group across time to evaluate ISTH impacts.
Progressive destruction of the lungs is the main cause of shortened life expectancy in people with cystic fibrosis (pwCF). Inflammation and respiratory infections play a key role in CF lung disease. Previous studies have shown that an increase in inflammatory markers predicts structural lung damage. Close monitoring of pwCF is crucial to adequately provide optimal care. Pulmonary management for pwCF involves treating infections and exacerbations and promoting exercise and mucociliary clearance to slow or prevent structural lung damage. To evaluate the treatment and incite timely interventions it is important for the pulmonary physician to be well-informed about the condition of the lungs. The main monitoring tools in regular CF care are lung function, sputum cultures, symptom reporting and more recently imaging by chest computed tomography (CT-scan) or magnetic resonance imaging (MRI). Strangely enough, there are currently no monitoring tools used in clinics to measure inflammation in the lung, although this is a main factor for progressive lung disease. New highly effective modulator therapy (HEMT) such as elexacaftor/tezacaftor/ivacaftor [ETI, Kaftrio®] is transforming CF treatment, vastly improving lung function and reducing exacerbations. Initial CFTR modulators like ivacaftor and lumacaftor/ivacaftor also improved lung function and reduced exacerbations, but studies showed that lung inflammation was still present. The long-term impact of ETI and its effect on inflammation is not yet known. Thus, monitoring pwCF on HEMT may be different from before, as lung damage seen on chest CT will be less apparent and lung function will improve considerably, therefore not being adequate markers for subtle changes in the lungs. Thus, the focus of monitoring in the era of highly effective CFTR modulators needs to change preferably focusing on measuring lung inflammation. An ideal monitoring tool for lung inflammation in pwCF should be non-invasive, efficient, and provide accurate and sensitive results. Currently, sputum and BAL are the most common methods for assessing inflammation, but BAL is invasive and sputum may not always be available. Exhaled breath analysis by the electronic nose (eNose) or gas chromatography-mass spectrometry (GC-MS) of volatile organic compounds (VOCs) shows promise as a non-invasive monitoring tool. Other promising markers and techniques are inflammatory markers in the blood (cytokines and micro-RNA (miRNA)) and urine. Thus, the objective of this project is to design novel, minimally invasive monitoring techniques capable of identifying lung inflammation in pwCF undergoing highly effective CFTR modulator therapy (ETI) compared to those not using CFTR modulators. The efficacy of these innovative techniques will be evaluated and verified against inflammatory markers in sputum, spirometry, and validated symptom and quality of life scores.
Dietary interventions have been consistently proposed as a part of a comprehensive strategy to lower the incidence and severity of atherosclerosis and cardiovascular diseases (CVD). Excessive consumption of fats enriched in saturated fatty acids (SFA) is associated with an increased risk of atherosclerosis and other CVD. By contrast, replacement of SFA with monounsaturated fatty acids (MUFA) and omega-3 long-chain polyunsaturated fatty acids (ω-3 PUFA) has been reported to be inversely associated with risk of atherosclerosis. This is partly due to the ability of MUFA (and PUFA) in modulating low-density lipoprotein (LDL) and triglyceride-rich lipoprotein (TRL) lipid composition and oxidation status, and thereby the functionality of such lipoproteins. While most of the nutritional studies have focused on elucidating the mechanisms by which dietary fats affect LDL and TRL, little or nothing is known about the regulatory effect of MUFA and PUFA on structure and functional remodelling of high-density lipoproteins (HDL). There is clear evidence of an inverse association between plasma levels of HDL and the formation of atherosclerotic plaques. However, recent studies have suggested that HDL may not be as beneficial as thought at least in patients with established cardiometabolic disorders. In those patients, the HDL behaves as pro-inflammatory lipoproteins. Until now, few studies have addressed this "dark side" of HDL and has never been evaluated the role of dietary fatty acids on HDL plasticity (i.e. phenotype and functionality). A better understanding of this duality between anti-inflammatory and pro-inflammatory HDL would be relevant to prevent HDL-related atherogenic dyslipidemias and to provide personalized dietary advices for a successful management of atherogenic lipid profiles. This step of proof-of-principle will determine the instrumental role of major fatty acids present on a diet (SFA, MUFA and MUFA plus ω-3 PUFA) in promoting or reversing the phenotype of pro-inflammatory HDL. We expect to offer a novel insight on HDL and its relationship with dietary fatty acids through the following objectives: 1) To analyse acute changes in the lipidome, proteome and functional properties of HDL in humans (healthy volunteers and patients with metabolic syndrome) upon a challenge of a meal rich in SFA, MUFA or MUFA plus ω-3 PUFA; and 2) To analyse the influence of diets rich in SFA, MUFA and MUFA plus ω-3 PUFA on HDL plasticity in a preclinical animal model of diet-induced metabolic syndrome and that develops atherosclerosis.
The purpose of this study is to determine the feasibility and preliminary efficacy of daily supplementation of freeze-dried blueberry to modulate inflammation-driven lack of motivation in 40 sedentary, older adults with depressive symptoms.
In a randomized controlled trial we will research the effect of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters. Participants will be divided into three groups: early time-restriction group (8:00 AM to 4:00 PM), mid-day restriction group (1:00 PM to 9:00 PM) and daily calorie restriction group (8:00 AM to 9:00 PM). Participants will follow dietary strategy with three planned meals and calorie restriction. Anthropometrical and biochemical parameters will be measured at baseline, after one month, two months and at after three months of intervention. Resting metabolic rate, ultrasound scan of abdomen and ultrasound scan of carotid arteries will be measured at baseline and after three months of intervention. In addition, stool samples will be also taken at baseline and after three months of intervention.
This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.
In recent times, the prevalence of obesity increases, reaching an epidemic scale. Elevated body weight is a risk factor in the development of several diseases such as diabetes, hypertension and cancer. Therefore, obesity management solutions, such as diet therapy are needed. The key issue is to choose the most appropriate diet to obtain an efficient outcome in losing weight, without experiencing adverse effects and a decrease in general health. A ketogenic diet, an auxiliary therapy for epilepsy, is recently one of the options commonly used for losing weight by overweight individuals, tempted by the commercials and internet influencers. However, there is limited knowledge about the effect of this diet on human health. To date, the majority of studies were conducted with a very-low-calorie regime applied before the bariatric surgeries, which itself may affect the loss of body weight, and in most studies, the control diets were missing. Taking into consideration that a ketogenic diet is an extremely eliminating diet, there is a risk of nutritional deficiencies after following it. Therefore, there is a strong need for more in-depth and comprehensive elucidation of the safety and physiological effects of the ketogenic diet used for the weight loss in overweight and obese individuals. This Project aims to evaluate the effectiveness of the eight-week, isocaloric, energy-restricted, ketogenic diet as a weight management solution in women with overweight and obesity compared to the standard, balanced diet with the same calorie content.