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Inflammation clinical trials

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NCT ID: NCT03442348 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Omega 3 and Fibre Intervention Study to Improve Metabolic Health

Start date: May 31, 2018
Phase: N/A
Study type: Interventional

Metabolic syndrome represents a major health burden worldwide affecting 20-30% of the population. This clustering of abnormalities that confers an increased risk of cardiovascular disease and type 2 diabetes mellitus, is the hallmark of "unhealthy" aging in longevity studies. Preventive strategies have so far failed since they have focused mainly on reducing caloric intake, ignoring the metabolic dysfunction in the aging body. The growing importance of the gut microbiota in all aspects of human health is clear, and unlike our genomes is potentially highly modifiable and tightly related to metabolic and immune efficiency, energy and fatty acid metabolism and satiety hormones. The investigators and others have reported that higher microbiome diversity correlates with significantly lower long-term risk of weight gain and metabolic syndrome. The investigators have recently shown that serum levels of omega-3 fatty acids correlate with higher microbiome diversity, and increased abundance of bacteria that produce butyrate are linked to lower inflammation of the gut. The investigators therefore propose to carry out a proof of concept nutritional intervention study in the TwinsUK cohort. The TwinsUK sample is probably the most detailed omic and phenotypic resource in the world and is ideal for this study. The mechanisms that result in improved microbiome composition and diversity will be explored in a highly focused novel interventional study hypothesizing that key fatty acid pathways are crucially involved in the link between diet, microbiome, immune phenotypes and metabolic syndrome. The specific objectives are to measure changes in gut microbiome composition in response to fibre supplementation compared to omega-3 fatty acid supplementation. The study will measure faecal metabolites relevant to fatty acid metabolism (short chain fatty acids), the abundance of microbial species linked to higher or lower inflammation and immune cell phenotypes to unravel the link between inflammation, diet and metabolic syndrome. There is a real lack of good diet intervention studies in this field and if successful this trial will pave the way to funding a wide variety of other diet intervention studies.

NCT ID: NCT03441919 Completed - Clinical trials for Cardiovascular Diseases

Activation Innate Immune System in Type 1 Diabetes

Start date: January 18, 2018
Phase:
Study type: Observational

Hyperglycemia is a well-known cardiovascular risk factor. It has also been shown that episodes of hyperglycemia increase the risk for cardiovascular diseases despite return to normoglycemia, a phenomenon termed 'glycemic or metabolic memory'. The molecular mechanism underlying this phenomenon remains unclear. Cardiovascular events, such as myocardial infarction and stroke are caused by atherosclerosis, which is characterized by low grade inflammation of the vascular wall, including accumulation of innate immune cells such as monocytes and macrophages. The investigators hypothesize that chronic hyperglycemia shifts intracellular metabolism of innate immune cells towards glycolysis and changes the epigenetic state of (progenitors of) innate immune cells (monocytes and macrophages), which reprograms these cells towards a more aggressive, pro-atherogenic phenotype, thereby accelerating atherosclerosis. In this study, the investigators aim to test this hypothesis. This research will reveal whether the innate immune cells of patients with chronic hyperglycemia show a durable shift in intracellular metabolism and epigenetic changes and whether this associates with vascular inflammation.

NCT ID: NCT03435861 Completed - Alzheimer Disease Clinical Trials

Effect of Neflamapimod on Brain Inflammation in Alzheimer's Disease Patients

VIP
Start date: October 8, 2018
Phase: Phase 2
Study type: Interventional

For this project, neflamapimod and placebo will be provided free of charge by the EIP company (www.eippharma.com). Neflamapimod is currently tested in 2 clinical trials in AD, one in Europe (The Netherlands) and one in the USA (clinical trials.gov/VX-745). The company commenced in May 2015 dosing in two phase 2a clinical studies in patients with Early AD: one in the Netherlands that is focused on PET amyloid imaging as the primary biomarker of drug effect, and one in the US (California) that is focused on Cerebrospinal fluid (CSF) evaluation to determine CSF drug concentrations and effects on inflammatory markers and disease biomarkers. Pharmacokinetic evaluation in these patients has demonstrated blood drug concentration levels in the predicted therapeutic range; and importantly, the data from the US study demonstrate that the drug achieves target drug concentrations in CSF, thus confirming the drug robustly enters the brain in humans. The present project offers us a unique chance to test this promising drug in AD patients. The aim of the study is to focus on PET neuroinflammation imaging as the primary biomarker of this drug effect. The chosen biomarker for imaging neuroinflammation in patients is [1 8F]-DPA714.

NCT ID: NCT03434236 Not yet recruiting - Surgery Clinical Trials

The Effects of Lipinova on Inflammatory and Proresolving Lipid Mediator Profiles After Orthopedic Surgery

Start date: March 15, 2018
Phase: N/A
Study type: Interventional

The aim of this pilot study is to investigate whether pre-operative supplementation with an over the counter dietary supplement containing a fractionated marine lipid concentrate derived from anchovy and sardine oil, Lipinova® (Solutex), improves the inflammatory profile and proresolving capacity in patients undergoing total knee arthroplasty. In addition, the investigators will compare the ability of two different dosing regimens to maximize SPM (Specialized Proresolving Mediators) availability.

NCT ID: NCT03431103 Recruiting - COPD Clinical Trials

The Effect of Exercise on Systemic Inflammation in Veterans With COPD and OSA

Start date: December 5, 2016
Phase: N/A
Study type: Interventional

The overlap syndrome (OS), i.e. the association of both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) in a single Veteran, is prevalent and associated with increased cardiovascular disease (CVD) morbidity. Home-based exercise interventions that translate to a lifestyle with increased physical activity (PA) are an ideal strategy as 150 minutes of leisure time PA a week is associated with a significant reduction in risk of CVD related events and death. This novel research study will help develop a home exercise intervention that is largely accepted by OS Veterans, as a first step toward implementing PA into the routine medical care of the large Veteran population with COPD and OSA. This data will be used for larger studies on CVD risk and its modification with exercise in OS, a research area that is urgently needed given its high impact on Veterans' morbidity, mortality and health-care associated costs.

NCT ID: NCT03430037 Enrolling by invitation - Clinical trials for Frail Elderly Syndrome

Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women

AFFIRM
Start date: February 6, 2018
Phase: Phase 2
Study type: Interventional

This is a pilot study to evaluate whether targeting inflammation will help reduce markers of insulin resistance inflammation, bone resorption and physical dysfunction in elderly women with gait disturbance. Positive results of this study would lead to the development of a larger clinical trial examining the effects of this intervention on age-related dysfunction.

NCT ID: NCT03429920 Completed - Inflammation Clinical Trials

Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

FS
Start date: September 23, 2018
Phase: N/A
Study type: Interventional

This research study will test the effects of Q CAN PLUS powder on serum lipids, selected inflammatory and oxidative parameters and genome-wide methylation

NCT ID: NCT03429478 Completed - Clinical trials for Inflammatory Response

Effect of Preoperative Music on Sterile Inflammation Induced by Laparoscopic Surgery

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Surgery induced sterile inflammation leaves behind a biomolecular footprint measurable by various pro-inflammatory markers e.g. IL-6, CD(Cluster of differentiation)19B, HsCRP(High-sensitivity CRP) etc. Music is a non-pharmacological means in attenuating this inflammatory pathway thereby improving Health related quality of life measurable by improved postoperative convalescence. Correct timing of music application is a lacuna in the knowledge. This research aims at evaluating the effect of preoperative music on sterile inflammation induced by index Laparoscopic Surgery (Laparoscopic Cholecystectomy) and its proposed beneficial effects on patient reported outcomes. A total of 50 patients divided into 2 groups (test and control) will be evaluated in this triple blind randomized controlled study aiming at evaluating the biomolecular signatures of sterile inflammatory response and its correlation with improved postoperative convalescence. All the patients will be followed up for a period of 1 month postoperatively to assess for overall improvement in health related quality of life. Collected data will be analysed using updated SPSS software and a p value of less than 0.05 will be taken as statistically significant in support of the measured indices.

NCT ID: NCT03427879 Completed - Clinical trials for Gut Permeability, Gut Inflammation

Effect of Flavonoids on Gut Permeability in Cyclists

Start date: September 14, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this investigation is to test the hypothesis that chronic supplementation with a dairy-based beverage containing a mixture of blueberry, green tea, and cocoa flavonoids (non-nutritive natural plant compounds) will ameliorate exercise-related changes in gut permeability and inflammation. In a previous feeding study in humans, (NCT02728570) a high flavonoid diet (flavonoids at 340 mg/1000kcal) was effective in mitigating gut permeability and inflammation in overweight and obese adults compared to a low flavonoid diet (10mg/1000 kcal). To test this hypothesis, 20 trained cyclists will complete a randomized crossover study with supplementation for 2 weeks with a dairy-based sports beverage containing either a high flavonoid (approximately 620 mg) or low flavonoid (approximately 5mg) beverage. After the two week intervention, cyclists will complete a 1 hour cycling trial (45 min at 65% VO2 max then 15 minute time trial). The primary endpoints will be gut permeability as measured by plasma intestinal fatty acid binding protein (I-FABP) and the differential sugar test. Secondary endpoints will include gut inflammation (measured via fecal calprotectin), plasma cytokines (IL-6, IL-10 and TNFα) and plasma LPS. In addition, the distance completed in the time trial is a secondary endpoint.

NCT ID: NCT03426267 Completed - Clinical trials for Inflammation and Pain Associated With Ocular Surgery

Evaluation of Efficacy and Safety of SDN-037

Start date: September 28, 2018
Phase: Phase 3
Study type: Interventional

The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle for the treatment of inflammation and pain associated with ocular surgery.