Clinical Research Directory

Little Cigar Oxidants

Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 3 exposure groups. These include a high oxidant little cigar exposure condition, a low oxidant little cigar exposure condition, and their usual cigarette. Biological samples will be collected before and after product usage.

DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes

Brief Summary This observational study will follow patients who undergo DIEP flap breast reconstruction to better understand a common surgical challenge called ischemia-reperfusion (I/R) injury. I/R injury can happen when a flap has a period without blood flow (ischemia) and then blood flow returns (reperfusion). This process may trigger inflammation and oxidative stress and is associated with fat necrosis or partial flap loss. 1\. What is being studied 1. The investigators will measure inflammation and oxidative stress markers in blood (for example, interleukin-6 \[IL-6\]) from before surgery through the first 72 hours after surgery. 2. These data will help map the normal and abnormal patterns of recovery after surgery and may inform future approaches to monitoring and protecting flap tissue. 3. No experimental drug or device is given to participants in this study. Separate animal studies are developing a near-infrared imaging and antioxidant nanomaterial (Mn/QD-SAC); this is not used in participants here. 2\. Who can take part 1. Women aged 18-70 scheduled for immediate DIEP flap breast reconstruction after breast cancer surgery. 2. Key exclusions include severe heart, liver, or kidney disease; significant clotting problems; active infection or autoimmune disease; long-term use of immunosuppressants/anti-inflammatory drugs; pregnancy or breastfeeding; or other reasons judged by the research team. 3\. What will happen if you join 1. After providing informed consent, participants will have blood drawn at five time points: pre-operative baseline (within 24 hours before surgery) and at 0, 6, 24, and 72 hours after surgery (about 10 mL each time; total \~50 mL). 2. Blood will be processed and stored under secure conditions and tested for inflammation and oxidative stress markers. 3. The investigators will also record routine clinical information from the medical record (such as age, BMI, surgery duration, ischemia time, and clinical assessments of flap outcomes and complications). 4. Participation does not change the participant's clinical care before, during, or after surgery. 4\. Risks and benefits 1. Risks are those of standard blood draws: brief pain, bruising, bleeding, dizziness, and rare infection. 2. There is no direct medical benefit to participants. Results may help improve understanding and future care for patients undergoing flap reconstruction. 5\. Privacy and data protection 1. Samples and data will be coded without names. Identifying information is stored separately with restricted access. 2. Research results are not routinely added to the medical record or returned to participants unless a finding has clear, actionable clinical significance and is approved by the ethics committee. 6\. Time commitment and costs 1. All blood draws occur during the routine hospital stay. There is no additional follow-up required after discharge. 2. There is no cost to participate. 7\. Voluntary participation Joining the study is voluntary. Participants may withdraw at any time without affecting their medical care.

Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure

The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.

Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes

The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.

Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters

The study will involve 80 elderly women, 40 eutrophic and 40 obese, divided into four groups, each with n=20. 1) Eutrophic Group (EG) undergoing only nutritional counseling (NC), 2) Eutrophic Group with NC and combined training (CT), 3) Obese Group (OG) undergoing only NC, and 4) Obese Group with NC and CT. The study will be divided into two main phases: an initial 9-week phase dedicated to NC, followed by a 20-week CT phase.

Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease

The objective of this study is to evaluate oxidative stress and/or inflammation in patients with Gaucher disease type I using a series of biomarkers and correlate with measurements of currently used diagnostic biomarkers.

Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress

The goal of this clinical trial is to learn whether drinking a daily serving of gazpacho can improve semen quality in men with reduced sperm quality. The study will also examine how this dietary intervention affects oxidative stress and whether it is well tolerated. The main questions this study aims to answer are: * Does daily consumption of gazpacho improve semen quality in men with altered semen parameters? * Does this dietary intervention affect levels of oxidative stress in semen? * Is daily gazpacho intake feasible and well tolerated as part of a Mediterranean diet? Researchers will compare a Mediterranean diet plus daily gazpacho intake with a Mediterranean diet alone to determine whether adding gazpacho provides additional benefits for male reproductive health. Participants will: * Follow a standardized Mediterranean diet for 12 weeks * Drink 330 mL of gazpacho every day or follow the diet without gazpacho * Provide semen samples at the start of the study and after 12 weeks * Complete a short diary to record adherence to the dietary intervention * Be followed for up to 18 months to record reproductive outcomes

Effect of Ginger Capsules on Inflammation, Oxidative Stress, and Endothelial Function

Randomized, double-blind, parallel, placebo-controlled clinical trial designed and conducted to evaluate the effect of daily consumption of ginger, on parameters related to inflammation, oxidative stress, and endothelial damage in adults with excess adiposity.

Effect of a Ginger-Based Beverage on Inflammation, Oxidative Stress, and Endothelial Function

Randomized, double-blind, parallel, placebo-controlled clinical trial designed and conducted to evaluate the effect of daily consumption of ginger, on parameters related to inflammation, oxidative stress, and endothelial damage in adults with excess adiposity.

Inflammation and Oxidative Stress in COPD

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, characterized by persistent airflow limitation, chronic inflammation, and increased oxidative stress. Despite optimal pharmacological treatment, many patients continue to experience symptoms, reduced exercise capacity, and frequent exacerbations. Pulmonary rehabilitation (PR) is an evidence-based, non-pharmacological intervention that improves symptoms, functional capacity, quality of life, and survival in patients with COPD; however, its biological effects on inflammatory and oxidative stress pathways remain insufficiently defined. This study aims to evaluate the effects of pulmonary rehabilitation on systemic inflammation and oxidative stress in patients with stable COPD. Serum levels of pro-inflammatory cytokines (interleukin-6 \[IL-6\], tumor necrosis factor alpha \[TNF-α\]) and the epithelial alarmin interleukin-33 (IL-33), which is released in response to airway epithelial injury, as well as nuclear factor erythroid 2-related factor 2 (NRF-2) gene and/or protein expression as a key regulator of antioxidant defense, will be measured before and after a standardized pulmonary rehabilitation program. By assessing changes in these biomarkers, this study seeks to determine whether pulmonary rehabilitation exerts disease-modifying effects beyond symptomatic improvement and functional outcomes. The findings are expected to provide novel insights into the biological mechanisms of pulmonary rehabilitation and to support its role as a targeted, cost-effective intervention in the comprehensive management of COPD.

Acute Effect of Apple Cider Vinegar on Postprandial Plasma Malondialdehyde in Adult With Obesity

Research on the benefits of apple cider vinegar has tended to focus on its hypoglycemic effects and lipid profile changes during long-term consumption, without exploring its acute effects on oxidative stress during short-term consumption. Therefore, this study aimed to determine whether apple cider vinegar consumption affects postprandial plasma MDA levels in obese adults. The hypothesis of this study is that apple cider vinegar consumption has an acute effect on changes in postprandial plasma MDA levels in obese adult subjects. Subject criteria are adults aged 19-59 years; obese nutritional status; based on a BMI of ≥ 25.0 kg/m² (according to the Asia-Pacific classification); in good general health. Exclusion criteria include pregnancy, breastfeeding, and menopause; consuming alcohol; intolerance to apple cider vinegar or fermented products. This preliminary study, a parallel, randomized, open-label, controlled clinical trial, compared two groups: a control group receiving a standard diet without apple cider vinegar, and an intervention group receiving a standard diet with a single dose of apple cider vinegar.

Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases

The goal of this clinical trial is to collect environmental, bio-humoral, and clinical data derived from patients with allergic contact dermatitis (ACD) and systemic metal allergic syndromes related to the exposure to heavy metals, nanoparticles, and emergent contaminants and from healthy subjects. The main question it aims to answer is: are environmental, bio-humoral, and clinical data derived from patients with ACD and systemic metal allergic syndromes, related to the exposure to heavy metals, nanoparticles, and emergent contaminants, different from ones obtained by healthy subjects? Researchers will compare serum and urine concentration of heavy metals and nanoparticles, patch test to metals, within-breath analysis of oscillometry parameters, serum zonulin, and serum levels of protein oxidation products among patients with systemic allergic syndrome (1st study group), patients with ACD (2nd study group) and healthy subjects (3rd study group). Participants will undergo: * measurement of exposure to heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper, through serum and urine measurement of concentration. * Patch test to before mentioned metals. * Within-breath analysis of oscillometry parameters. * Measurement of serum zonulin (related to gastro-intestinal exposure). * Measurement of serum levels of protein oxidation products (as markers of systemic oxidative stress).

Chardonnay Marc and Vascular Response

This study aims to obtain data on the potential influence of Vine to Bar product(s) containing Chardonnay marc on cardiometabolic health. These initial studies will inform the design and timing of data collection for future dietary intervention trials that will examine the influence of Chardonnay marc intake on outcomes/biomarkers of both cardiometabolic health and the gut microbiome. This includes collecting data on the potential differences in response to the products based on the unique food matrix for each of the products that will be tested. Moreover, as there is a paucity of data on the influence of cocoa flavanol intake on vascular function beyond 4 hours post intake, the response of the selected outcomes will be assessed after 6 hours of flavanol intake. This is a time point that captures the increased circulating presence of microbial derived flavanol metabolites.

The ROAR Study: Reactive Oxygen Species and Reproduction

This is a prospective cohort study characterizing follicular fluid and serum levels of oxidative stress in women with various infertility diagnoses undergoing in vitro fertilization, and assessing the relationship of oxidative stress to oocyte competence as determined by embryo development outcomes. Furthermore, we will measure oxidative stress in sperm and correlate the overall oxidative stress within the couple with IVF and pregnancy outcomes of the resultant embryos.

EFFECTS OF A YERBA MATE EXTRACT IN REDUCING METABOLIC SYNDROME IN OVERWEIGHT INDIVIDUALS

Yerba mate (Ilex paraguariensis), a traditional drink consumed in different parts of the word, but especially in southern Brazil, is an importante source of polyphenols and has a high antioxidant potencial, With a moderate content of methylxanthines, yerba mate has stood out for its promising effects in modulating metabolic pathways in pre-clinical models. However, its beneficial effets in clinical trials have yet to be elucidated. Overweight and chronic non-communicable diases are urgent public health conditions and reducing the risk of these conditions through food sources is one of the most sustainable approaches. This study aims to evaluate the impact of a standardized extract of yerba mate on nutritional, biochemical, metabolic, inflammatory and antioxidant status parameters in overweight individuals compared to a placebo. A double-blind, parallel, randomized, placebo- controlled clinical trial will be conducted involving 80 overweight individuals. The subjects will receive an encapsulated yerba mate extract totaling 2,250 mg or a corresponding placebo, fractionated three times a day. This amount was defined according to previous studies thet estimated the habitual intake of yerba mate in the form of chimarrão or tererê by adults in a city in the southern region of the country. Anthropometric measurements, composition, blood pressure and blod and stool samples will be collected for nutritional assessment, metabolic and inflammatory parameters and antioxidant status assessment on days 0 and 90. The data will be analyzed descriptively and inferentially. Differences in the individuals characteristics at baseline and comparisons between groups will be aseessed using the difference of means test (depending on the normality of the data) and chi-square or Fisher-s exact test for categorical variabes, In addition, to compare the effect of the intervention between the groups, a two-way analysis of covariance will be used. A 5% significance level will be adopted. It is expect to find positive effects of yerba mate extract on the parameters assessed.

Cerebral Hemodynamic Effects of Oxygen and Antioxidants (CHEOXANT)

This study is called CHE-OX-ANT (Cerebral Hemodynamic Effects of Oxygen and Antioxidants). It is a single-center, academic research project led by the Department of Intensive Care at Erasme Hospital (Université Libre de Bruxelles). The study focuses on understanding how the brain and blood vessels react when a person breathes pure oxygen and how these effects may be influenced by giving vitamin C, an antioxidant. Oxygen is one of the most common treatments in hospitals. While it can be life-saving, too much oxygen may sometimes cause harmful effects, such as oxidative stress (an imbalance between damaging molecules called free radicals and the body's defenses). Antioxidants like vitamin C may help counteract these effects. The goal of the study is to examine how a short period of high oxygen (30 minutes of 100% oxygen through a mask) affects cerebral hemodynamics, microcirculation, microperfusion, blood markers (levels of oxidative stress, antioxidant activity, and microparticles). The study will also test whether giving vitamin C beforehand changes these responses compared to a placebo (saline solution). Each volunteer will participate in two sessions, one week apart. Before each session, participants will receive either vitamin C (given intravenously) or a placebo (saline). They will not know which one they receive. Then, they will breathe 100% oxygen for 30 minutes through a facial mask. Measurements will be taken at three times: before oxygen (t0), just after oxygen (t1), and 1 hour later (t2). These include: ultrasound of the brain's blood flow (transcranial Doppler), measurements of skin perfusion and blood samplings.

Relaxin Therapy for Atrial Fibrillation

Atrial fibrillation (AF) is the most common heart rhythm disorder. The presence of AF increases the risk of death and is associated with a 5-6-fold increase in stroke incidence, due almost exclusively to thrombus formation in the heart. Current therapies for AF are limited. The evaluation of new, more effective treatments for preventing AF recurrence remains a critical unmet clinical need. AF is considered a progressive disease that increases in prevalence with age and can convert from "paroxysmal" to "persistent" to "permanent" AF in a single individual. This progression results, in part, from high oxidative stress and progressive adverse electrical changes in the heart. Compelling preclinical and clinical data indicate that Relaxin, a naturally occurring peptide hormone, may reverse the electrical remodeling. Thus, our overall objective is to investigate the effects of Relaxin in Veterans who have failed medical management for symptomatic AF and is referred to Cardiac Electrophysiology Laboratory for catheter ablation and pulmonary vein isolation. We will determine whether Relaxin therapy, in addition to the standard of care, counteracts the oxidative stress-related electrical derangement and reduces the post-ablation AF burden. A unique aspect of this proposal is that it is based in part on observations derived from the basic, translational and computational labs of the PI and co-investigators and from the observations by the PI while caring for patients with AF. As such, this proposal represents a true progression from the bench to the bedside. If successful, our findings may lead to the design of a new, more effective treatment for a major unmet public health problem in the United States as well as the world.

Impact of Haskap Berries on Recovery From High Intensity Resistance Training

The purpose of this clinical trial is to determine how certain food items affect oxidative stress, inflammation, and performance recovery from exercise induced muscle damage in a resistance trained population. The main questions The investigators aim to answer are the following: * Do Haskaps speed the recovery of oxidative stress and inflammation markers after an intense lower body workout in resistance trained adults? * Do Haskaps speed the recovery of performance measures after an intense lower body workout in resistance trained adults? * The data collected in this investigation may also be used to ask additional questions not yet identified. For example, the investigators may use the stored samples to evaluate how the blood metabolites of participants differ before and after intense exercise. These additional questions are called secondary analyses. Please note that no genetic analysis will be conducted and racial and ethnic differences among participants will not be used in any secondary analyses. Researches will compare Haskap juice to a color, flavor and carbohydrate matched placebo to see if Haskaps speed recovery in inflammation, oxidative stress and performance. * Participants will be asked to drink either Haskap juice or placebo and follow a low polyphenolic diet * Participants will perform an intense resistance workout * Participants will have their blood drawn before and after the workout * Performance will be analyzed at 24, 48 and 72 hours after the workout

OpioidRedoxStudyII

This observational study aims to examine the relationship between opioid use and redox balance in adults. Redox balance reflects the level of oxidative stress in the body, which is known to play an important role in many biological processes and diseases. Participants who use opioids will be included in the study. No experimental treatment or changes to current medical care will be provided as part of this study. Biological samples may be collected to assess redox-related biomarkers, and relevant clinical and demographic information will be recorded. The results of this study are expected to improve understanding of how opioid exposure is associated with redox balance in adults. This information may help inform future research on the biological effects of opioids and potential strategies to reduce harm associated with long-term opioid use.

The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies

The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function. In Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim. In Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.

Effect of Hydrogen Gas on Hyperbaric Oxygen Toxicity

The goal of this trial is to investigate whether adding a small fraction of hydrogen gas to an oxygen-enriched breathing mixture can reduce pulmonary oxygen toxicity (POT) in healthy and active divers from the Swedish Armed Forces. The main questions it aims to answer are: * Does hydrogen gas reduce oxidative stress and changes in pulmonary function associated with prolonged hyperbaric oxygen exposure? * What are the underlying pathophysiological mechanisms of pulmonary oxygen toxicity? Researchers will compare oxygen-enriched breathing gas with 1-2% hydrogen to oxygen-enriched gas with 1-2% nitrogen (control) to see if hydrogen provides protective effects against POT during hyperbaric exposure. Participants will: * Complete two hyperbaric exposure sessions (hydrogen vs. nitrogen), each lasting 240 minutes at 1.75 ATA * Undergo pulmonary function tests and sampling of blod and urin before and after each session * Serve as their own controls in a double-blind, randomized, crossover study design

Probing the Role of Mitochondrial Oxidative Stress in Impaired Vascular Function Among Young Adults With Early Life Adversity

Adverse childhood experiences (ACEs) represent highly stressful events in the first 18 years of life that include abuse, neglect, and household and community-level dysfunction. Greater exposure to ACEs are associated with greater increases in the risk of cardiovascular diseases and death. Our laboratory has previously observed that vascular function is disrupted in young adults with prior ACE exposure, even though these individuals appear to be healthy clinically (i.e., no classic clinical cardiovascular disease risk factors). There is a need to identify and understand the biological mechanisms underlying these vascular impairments to inform effective interventions to reduce cardiovascular risks the millions of individuals affected by ACEs. The body's response to stress is coordinated across various systems, all of which depend on energy supplied by mitochondria (often referred to as the "powerhouse of cells"). Based on new evidence across multiple physiological systems from our team, our overarching hypothesis is that disruption of mitochondrial function contributes to cardiovascular impairments among young adults with ACEs. Here we propose the initial pilot work necessary to begin to understand these associations, which will directly inform identification of individuals who may be most vulnerable to stress-related cardiovascular risk and the development of interventions to promote cardiovascular-stress resilience. Our aims are to: 1. Determine whether mitochondrial oxidative stress contributes to impaired vascular function among young adults who experienced early life adversity. 2. Determine whether reducing mitochondrial oxidative stress improves the cellular stress and integrated cardiovascular response to laboratory-based psychosocial stress among young adults who experienced early life adversity.

NON CANONICAL ACTIVATION OF BOOD COAGULATION

Cardiovascular diseases (CVD) are the major cause of mortality and morbidity worldwide and most of them are characterized by enhanced generation of active -thrombin (T) from the inactive Prothrombin zymogen (ProT), a reaction catalysed by factor Xa. CVD may be idiopathic, but also appear as the expression of thrombotic complications occurring with variable incidence and severity in different (apparently unrelated) diseases, such as for instance Type-2 Diabetes (T2D) , Chronic Kidney Disease (CKD), Inflammatory Bowel Disease (IBD) , Cancer , rheumatoid (RA) arthritis , autoimmune diseases such as the AntiPhospholipid Syndrome (APS), bacterial and viral infectious diseases, and amyloid-related diseases such as Alzheimer's disease, IgG light-chain amyloidosis and human transthyretin (hTTR) Senile Systemic Amyloidosis.This Project aims at combining different and complementary expertise with the general purpose of identifying new pathogenetic mechanisms for CVD and explored the possibility to devise novel and more effective therapeutic strategies.

Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant

This study aims to investigate the association between serum biomarkers and clinical response to anti-VEGF or dexamethasone implant by assessing OCT-biomarkers in patients with diabetic macular edema, DME, and to compare these with a group of naive patients (those not previously treated for DME).