Clinical Research Directory

Turmeric Extract and Oxidative Stress in Muaythai Athletes and Sedentary Men

This study examined whether taking turmeric extract for 28 days affects oxidative stress and antioxidant defenses in healthy men who practice Muaythai and men who do not exercise regularly. Oxidative stress occurs when reactive molecules exceed the body's protective defenses and can damage cells. The study included 44 healthy men aged 18-25 years in four groups of 11: Muaythai athletes without supplementation, Muaythai athletes taking turmeric extract, men who did not exercise regularly and received no supplementation, and men who did not exercise regularly and took turmeric extract. Participants were first categorized as Muaythai athletes or sedentary individuals according to their physical activity status. Within each category, participants were randomly allocated to the turmeric supplementation group or the control group using a lottery method. The supplementation groups received 400 mg of turmeric extract daily for 28 days. The athlete groups followed a structured Muaythai training program. Blood samples were collected on Day 1 and Day 28 to measure malondialdehyde, a marker of oxidative stress, and catalase and reduced glutathione, which are involved in the body's antioxidant defenses. Changes over time were evaluated within and between groups.

Effect of Paracetamol Administration Timing on Oxidative Stress in Children Undergoing Sevoflurane Anesthesia

This study investigated the effects of paracetamol administration on oxidative stress in children undergoing inguinal hernia surgery under sevoflurane-based general anesthesia. Oxidative stress occurs when the production of potentially harmful molecules exceeds the body's antioxidant defenses. Anesthesia and surgery may influence this balance. The study compared two groups of children who received intravenous paracetamol at different stages of anesthesia. In one group, paracetamol was administered before premedication with midazolam and induction of anesthesia with sevoflurane. In the other group, paracetamol was administered after midazolam premedication and induction of anesthesia. Blood samples were collected at four predefined time points to measure markers of oxidative stress and antioxidant defense. The aim was to determine whether the timing of paracetamol administration influenced oxidative stress parameters in children undergoing surgery.

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.

Effects of Manual Acupuncture on Malondialdehyde Levels and State Anxiety Inventory Scores in Active Smokers: A Randomized Controlled Clinical Trial

This study aims to evaluate the effects of a single session of manual acupuncture on oxidative stress and state anxiety in active smokers. Oxidative stress will be assessed using plasma malondialdehyde (MDA), while state anxiety will be evaluated using the State Anxiety Inventory (SAI). Participants will be randomly assigned to receive either manual acupuncture or sham acupuncture. MDA concentration and SAI scores will be assessed at baseline and 90 minutes after completion of the intervention. The study will also explore the correlation between changes in plasma MDA concentration and changes in SAI scores to assess the relationship between oxidative stress and state anxiety following the intervention.

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.

Development of a Coffee Pulp Infusion as a Strategy for Recovery After Moderate Physical Exercise in a Healthy Population.

The goal of this clinical trial is to learn if a coffee pulp infusion works to improve muscle recovery after moderate physical exercise in a healthy adult population. It will also learn about its effects on oxidative stress and inflammation caused by exercise according to sex. The main questions it aims to answer are: * Does the coffee pulp infusion reduce the levels of oxidative stress, inflammation, and muscle damage markers after physical activity? * Are there differences between men and women regarding the response to the exercise and the benefits of the infusion? Researchers will compare the coffee pulp infusion to a placebo (a wheat bran infusion equalized in appearance and flavor but with low bioactive potential) to see if the coffee pulp infusion works to improve muscle recovery. Participants will: * Take the coffee pulp infusion or the placebo twice every day for 45 consecutive days. * Complete a total of 6 clinic and sports center appointments for physical tests, anthropometric records, and hemodynamic monitoring. * Perform a leg extension exercise protocol specifically calibrated to induce muscle stress and fatigue. * Provide capillary blood and morning urine samples at specific time points to measure biomarkers and metabolomic responses. * Complete several questionnaires regarding their sociodemographics, physical activity, dietary index, and perceived muscle soreness or effort.

Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery

This study will compare opioid-free anesthesia and opioid-based anesthesia in adult euthyroid patients undergoing elective thyroidectomy. Opioid-based anesthesia is commonly used during surgery, but opioids may be associated with adverse effects such as nausea, vomiting, respiratory depression, hyperalgesia, and increased postoperative opioid use. Opioid-free anesthesia uses non-opioid medications as part of a multimodal strategy to provide intraoperative analgesia. The main aim of this prospective randomized study is to evaluate whether opioid-free anesthesia changes the perioperative oxidative stress response compared with opioid-based anesthesia. Oxidative stress will be assessed using serum biomarkers, including native thiol, total thiol, disulfide, total antioxidant status, total oxidant status, and oxidative stress index. Eligible patients will be randomly assigned to receive either opioid-free anesthesia or fentanyl-based opioid anesthesia. Blood samples will be collected before anesthesia induction, 30 minutes after extubation, and 24 hours after surgery. The study will also compare postoperative pain scores, rescue analgesic requirement, postoperative nausea and vomiting, recovery characteristics, and intraoperative hemodynamic variables between the two anesthesia strategies.

Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD

Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional CV risk factors. Arterial dysfunction is an important nontraditional CV risk factor gaining increased recognition in the field of nephrology. This process is best represented, both physiologically and pathophysiologically, by increases in the gold standard measure of arterial stiffening, carotid to femoral artery pulse wave velocity (CFPWV), which reflects, in particular, increases in aortic stiffness. Aortic stiffening with CKD is mediated by structural and functional (increased vascular smooth muscle tone) changes in the arterial wall stimulated by oxidative stress and chronic low-grade inflammation. Caloric restriction (CR) is a promising strategy for prevention of CKD-associated arterial dysfunction and CVD. However, long-term adherence to chronic CR regimens with optimal nutrition is very difficult to achieve. Research has shown that boosting NAD+ bioavailability to stimulate SIRT-1, a "CR mimetic" approach, reduces CFPW and oxidative stress in old mice, and this lab recently took the first step in translating these findings in a study of adults with normal kidney function and elevated systolic blood pressure (SBP). The data found that supplementation with nicotinamide riboside, a natural, commercially available precursor of NAD+ and novel CR mimetic, increased NAD+ bioavailability and reduced CFPWV and SBP. A randomized, placebo-controlled, double-blind, single-site phase IIa clinical trial to assess the safety and efficacy of oral nicotinamide riboside (500 mg capsules 2x/day; NIAGEN®; ChromaDex Inc.) for 3 months vs. placebo for decreasing aortic stiffness and SBP in patients (35-80 years) with stage III and IV CKD is being proposed. It is hypothesized that treatment will reduce CFPWV and SBP, as related to increases in systemic NAD+ bioavailability and reductions in oxidative stress, and inflammation. Aim 1: To measure CFPWV (primary outcome) before/after nicotinamide riboside vs. placebo treatment; Aim 2: To measure casual and 24h-ambulatory SBP (secondary outcome) before and after treatment; Aim 3: To determine the safety and tolerability of treatment with nicotinamide riboside vs. placebo; Aim 4: To measure systemic NAD+ and NAD+-related metabolite concentrations, as well as circulating markers of oxidative stress, inflammation, and vasoconstriction factors before and after treatment.

The Effect of Training on Oxidative Stress in Patients With kneeOA.

A six week patient study that intends to prove that training helps improve the life of people with osteoatritis of the knee. It looks at pain and function in daily life and markers in the blood that show stress at a cell level.

The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response

The subject of doctoral dissertation: Assessment of the effects of a meatless, ketogenic restrictive diet on body composition, strength capacity, oxidative stress and immune response During planning of research and topic of the doctoral dissertation, it was considered how to modify a standard ketogenic diet rich in saturated fatty acids so that the use of this model of nutrition has the most anti-inflammatory effect. Therefore, it was decided to conduct a research to check whether a diet rich in omega-3 polyunsaturated fatty acids will show such an effect when following a high-fat diet. Hypotheses: 1\. The ketogenic diet reduces systemic inflammation. 2.The ketogenic diet reduces oxidative stress. 3. The ketogenic diet reduces body fat. 4. A ketogenic diet does not worsen strength performance.

New Zealand Blackcurrant and Recovery in Elite Taekwondo

This randomized, double-blind, placebo-controlled trial evaluated the effects of short-term supplementation with anthocyanin-rich New Zealand blackcurrant (NZBC) extract on exercise-induced muscle damage, oxidative stress, antioxidant status, inflammatory responses, and perceived muscle soreness in elite male taekwondo athletes. Thirty national-level male taekwondo athletes were enrolled and randomly assigned in a 1:1 ratio to receive either NZBC extract (CurraNZ®, UK; 600 mg/day providing approximately 210 mg anthocyanins) or a matched placebo for 7 days. Blood samples and muscle soreness ratings were collected at baseline, immediately after exercise, 24 hours after exercise, and after 7 days. The primary outcome was plasma creatine kinase (CK). Secondary outcomes included reactive oxygen species (ROS), total antioxidant capacity (TOAC), protein carbonyls, inflammatory cytokines (IL-6, TNF-α, and IL-10), and perceived muscle soreness assessed using a visual analog scale (VAS). The study was approved by the Biruni University Clinical Research Ethics Committee (No. 2015-KAEK-80-23-33; December 22, 2023). Written informed consent was obtained from all participants.

Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

This project seeks to determine how e-cigarette (EC) physical design features, including those that allow the user to manipulate the quality and quantity of aerosols, affect exposure and toxicity from oxidants and other aerosol constituents.

Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse

Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle mitochondrial dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are a consequence of the aging process. The combination of inactivity and aging poses an added health threat to these individuals by accelerating the negative impact on vascular and skeletal muscle function and dysfunction. The underlying factors leading to vascular and skeletal muscle dysfunction are unknown, but have been linked to increases in oxidative stress. Additionally, there is a lack of understanding of how vascular function is impacted by inactivity in humans and how these changes are related to skeletal muscle function. It is our goal to investigate the mechanisms that contribute to disuse muscle atrophy and vascular dysfunction in order to diminish their negative impact, and preserve vascular and skeletal muscle function across all the lifespan.

The Impact of 12-week Ashwagandha Supplementation Induced by Resistance Training on Strength, Levels of Neurotrophic and Stress Response Proteins, Oxidative and Psychological Stress, and Cognitive Function in Physically Active Male Adults

This clinical trial will study the effects of Ashwagandha (Withania somnifera), a natural plant extract, on physical and mental health in adult men. Ashwagandha is known for its potential to reduce stress, support hormonal balance and improve sleep and physical performance. The study will explore how taking Ashwagandha for 12 weeks, with resistance training, affects various health markers such as stress hormones, brain function, muscle strength, body composition, sleep quality, and cognitive abilities. Participants will be healthy, non-smoking men aged 25-40, with regular resistance training experience. They will be randomly assigned to one of two groups: (1) weight training + Ashwagandha, (2) weight training + placebo. The study is double-blinded, meaning neither participants nor researchers will know who is receiving Ashwagandha or placebo. Participants will: * Take Ashwagandha or a placebo every day for 12 weeks * Train in the gym three times a week Researchers will assess changes in blood markers (like cortisol, testosterone and BDNF - brain-derived neurotrophic factor), physical performance (muscle strength and endurance), sleep quality, stress perception and cognitive function before and after the 12-week period. The goal is to better understand how Ashwagandha works.

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.

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.

Savannah Environmental Nutrition Study (SENS): Nutrition Intervention to Reduce Air Pollution-Related Airway Inflammation and Oxidative Stress

This pilot clinical trial will evaluate the feasibility and potential health effects of a nutrition-based intervention among adults living in communities affected by air pollution near the Port of Savannah, Georgia. Participants will be assigned to either a nutrition intervention group or a control group. The intervention group will receive biweekly grocery deliveries emphasizing foods naturally rich in antioxidants and anti-inflammatory nutrients, including vitamins C and E, omega-3 fatty acids, and polyphenols. The control group will continue their usual dietary practices during the study period. The study will evaluate whether the nutritional intervention is associated with changes in selected respiratory, oxidative stress, and cardiometabolic health indicators. Assessments will include fractional exhaled nitric oxide (FeNO) as a marker of airway inflammation, hydrogen peroxide (H₂O₂) in exhaled breath condensate as a marker of oxidative stress, systolic and diastolic blood pressure, resting heart rate, and glycated hemoglobin (HbA1c). Indoor concentrations of particulate matter (PM), nitrogen dioxide (NO₂), and ozone (O₃) will also be monitored to characterize participants' household air-pollution exposures. Measurements will be collected at baseline and at subsequent study assessments, as specified for each outcome. Findings from this pilot study will be used to evaluate feasibility, estimate changes in health outcomes, and inform the design of a larger clinical trial investigating nutritional approaches to potentially reduce health effects associated with air-pollution exposure.

Effect of Rosmarinus Officinalis Extract on Oxidative Stress and Inflammatory Biomarkers in Patients With Type 2 Diabetes (T2DM)

This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are followed for six months. A data cut-off at Month 3 is used for the analysis of metabolic, oxidative stress, and cytogenetic outcomes, while selected inflammatory and cardiovascular biomarkers continue to be assessed through Month 6. The study investigates the potential complementary effects of methanolic rosemary extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.

Effect of Cordyceps Supplementation Timing on Physiological Responses and Aerobic Adaptation in Athletes

Athletes frequently perform high-intensity exercise to improve physical performance and aerobic capacity. However, such training can induce exercise-induced muscle damage, oxidative stress, and inflammatory responses that may delay recovery and compromise subsequent training adaptations. Optimizing recovery strategies is therefore essential to maintain performance, reduce injury risk, and support long-term athletic development. Cordyceps is a medicinal mushroom that contains several bioactive compounds, including cordycepin and polysaccharides, which have demonstrated antioxidant, anti-inflammatory, and immunomodulatory properties. Although previous studies have reported beneficial effects of Cordyceps supplementation on exercise performance and physiological function, limited evidence exists regarding the optimal timing of supplementation relative to exercise. This study aims to investigate the effects of different Cordyceps supplementation timing strategies on physiological responses and aerobic adaptation following acute and chronic exercise training. Participants will be assigned to receive Cordyceps supplementation before exercise, after exercise, or placebo. The study will evaluate biomarkers of inflammation (IL-6), oxidative stress (MDA), muscle damage (CK), aerobic capacity (VO2max), and neuromuscular performance assessed using countermovement jump (CMJ) testing. The findings of this study are expected to provide evidence-based recommendations regarding nutritional recovery strategies and supplementation timing to optimize recovery and training adaptation in athletes and physically active individuals.

Hyaluronic Acid as an Adjunct to Non-Surgical Periodontal Therapy in Smokers

The goal of this clinical trial is to evaluate whether hyaluronic acid (HA) improves periodontal healing in people with periodontal disease who smoke. Moreover, the effects of HA on biomolecules and bacteria levels will be assessed during the follow up period. The main questions it will answer are: Will periodontal sites treated with HA gel after non-surgical periodontal treatment (NSPT) lead to better outcomes in clinical parameters compared to the sites treated with NSPT only in smokers? Will adjunctive use of HA gel reduce oxidative stress markers and bacteria levels during follow-up? Researchers will compare periodontal sites receiving NSPT with adjunctive HA gel application to sites receiving NSPT alone to determine whether HA provides additional clinical, biochemical and microbiological benefits. Participants will: * first receive full-mouth NSPT then, randomization will be performed in selected jaw to determine the test sites. These two interproximal test sites will additionally receive HA gel application. * attend follow-up visits at 1, 3 and 6 months for clinical periodontal measurements and to provide gingival crevicular fluid samples (GCF) and subgingival samples. The GCF samples will be evaluated for Metallothionein (MT) and 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels and subgingival samples for periodontal pathogens.

Oxidative Stress and Cardiovascular Risk in Patients With Rheumatoid Arthritis

The pathogenic process underlying atherosclerosis resembles a chronic inflammatory response in which oxidative stress is involved. Similarly, oxidative stress is widely recognized to play an important role in the clinical course and pathogenesis of rheumatoid arthritis (RA). RA has been associated with accelerated atherosclerosis. This cross-sectional study will include patients with RA. The primary objective is to evaluate the association between selected oxidative stress biomarkers-serum malondialdehyde levels, superoxide dismutase, and glutathione peroxidase-and the presence of subclinical atherosclerosis and carotid arterial stiffness in patients with RA. We will subsequently assess whether these molecules are related to cardiovascular disease determinants, including inflammatory dyslipidemia, insulin resistance, and beta-cell dysfunction, which may occur in this condition. This study will further explore the relationship between oxidative stress and cardiovascular disease in RA.

NVTIA® Ergothioneine for Healthy Aging and Skin Health

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of NVTIA® Ergothioneine, a branded ergothioneine ingredient, on healthy aging biomarkers and skin health in healthy adults aged 40 to 65 years. Participants will receive either NVTIA® Ergothioneine or a matching placebo once daily for 12 weeks. The primary objective of this study is to evaluate the effects of NVTIA® Ergothioneine supplementation on biomarkers associated with oxidative stress and healthy aging. Secondary objectives include assessment of skin elasticity, skin hydration, inflammatory biomarkers, and overall safety. The findings of this study are expected to provide clinical evidence supporting the role of NVTIA® Ergothioneine in promoting healthy aging and maintaining skin health.

Black Forest Cocoa Flavanol Supplementation and Health Trial

This randomized, double-blind, controlled clinical trial will evaluate the effects of daily cocoa flavanol supplementation on vascular and inflammatory biomarkers in healthy adult men aged 30 to 75 years. Participants will be randomized to receive either a cocoa flavanol supplement or a nutrient-matched low-flavanol control product for 4 to 8 weeks. The study will assess changes in inflammatory biomarkers, endothelial function, oxidative stress markers, vascular measurements, and circulating endothelial progenitor cell-related markers. Optional assessments include flow-mediated dilation and single-cell RNA sequencing of peripheral blood mononuclear cells to explore mechanistic biological responses to cocoa flavanol supplementation.

Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient

This double-blinded randomized controlled trial aims to investigate the effect of intraoperative dexmedetomidine administration on early flap viability and microvascular integrity in cancer patients undergoing elective microvascular reconstructive surgery. The primary outcome is clinical flap viability within 48 hours postoperatively, assessed using a standardized scoring system based on flap color, temperature, capillary refill time, and tissue turgor. Secondary outcomes include the evaluation of biomarkers related to endothelial glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammation (IL-6, IL-10), thrombosis (PAI-1), and angiogenesis (VEGF), as well as microcirculatory assessment using Sidestream Dark Field (SDF) imaging. The study is designed to determine whether dexmedetomidine improves early surgical outcomes by modulating pathophysiological processes involved in microvascular flap success.