Document text
Principal Investigator: Thomas Ekkehard Ritz
Organization: SOUTHERN METHODIST UNIVERSITY
Fiscal Year: 2024
Award: $485,483
Funding agency: National Center for Complementary and Integrative Health
Summary
Respiratory tract infections cause a considerable burden to health care systems and societies as a whole, which has been exasperated by COVID-19. Available preventative treatments for respiratory infections and the common cold have remained unsatisfactory and are often not adhered to. Psychological factors, such as stress, increase risk for respiratory infections and the common cold. A possible mechanism for this relationship could be reduced levels of nitric oxide (NO), which serve as a first-line defense mechanism. NO is reduced during periods of psychological stress, such as academic finals in students. Boosting levels of NO during periods of stress may provide a prevention strategy for respiratory infections, especially in populations with high transmission risk. Our pilot data suggests that beetroot juice elevates the fraction of exhaled NO (FENO) and attenuates cold symptoms during stressful final exams. The current study proposes a three-arm, double-blinded, and placebo-controlled trial design (conditions: one daily active dose and one daily placebo dose, two daily active doses, two daily placebo doses, with 50 participants in each condition, total N=150), with students under final examination stress, to examine the usefulness of beetroot juice in elevating airway NO measured by FENO and thereby reducing respiratory viral infections tested by viral polymerase chain reaction. The current study will 1) demonstrate that a 7-day trial of daily beetroot juice or de-nitrated placebo beetroot juice is feasible logistically and with acceptable adherence during a period of real-life stress, 2) generate initial evidence for the capacity of beetroot juice to increase elevations in FENO, which correlates with reductions in infection using respiratory viral panel, (biological signature), 3) examine dosage effects, in that two daily active doses of beetroot juice are likely more potent than one daily dose or placebo in elevating FENO. The trial will use a well-controlled paradigm of a naturalistic stress to demonstrate that airway NO production is the critical target mechanism underlying the beneficial effects of dietary nitrate supplementation on respiratory tract infection and common cold symptoms. Two university sites will recruit participants and their findings and experience in team integration will prepare a regular-size two-arm, double-blind randomized controlled clinical trial of beetroot juice effects on respiratory infection, which will include additional recruitment sites across the Southwestern US.
Terms: <Absenteeism at work><Actions of Nitric Oxide in the Heart><Acute Nasopharyngitis><Adherence><Adverse effects><Aeroseb-HC><Airway infections><Airway mucosa><Approaches to prevention><Attenuated><Biological><Body Tissues><Buffers><COVID-19><CV-19><Cardiovascular><Cardiovascular Body System><Cardiovascular Organ System><Cardiovascular system><Cell Communication and Signaling><Cell Phone><Cell Signaling><Cellular Phone><Cellular Telephone><Cessation of life><Cetacort><Chronic stress><Clinical Trials><Common Cold><Coronavirus Infectious Disease 2019><Cort-Dome><Cortef><Cortenema><Cortisol><Cortispray><Cortril><Cytostatic Agents><Cytostatic Drugs><Cytostatics><Data><Death><Defense Mechanisms><Dependence><Dermacort><Developed Countries><Development><Dietary Intervention><Dose><Double-Blind Method><Double-Blind Study><Double-Blinded><Double-Masked Method><Double-Masked Study><Economic Burden><Eldecort><Employee Absenteeism><Endogenous Nitrate Vasodilator><Endothelium-Derived Nitric Oxide><Epithelial Cells><Exercise Physiology><Exhalation><Exhaling><Feasibility Studies><Health Care Systems><Healthcare Systems><Heart Vascular><Hepatic Proliferation Inhibitor><Hour><Human><Hydrocortisone><Hydrocortone><Hytone><Industrialized Countries><Industrialized Nations><Infection><Intake><Intervention><Intervention Strategies><Intracellular Communication and Signaling><Juice><L arginine amidinohydrolase><Life Stress><Link><Liver Immunoregulatory Protein><Liver-Derived Inhibitory Protein><Lung><Lung Respiratory System><Measures><Mediation><Medicine><Mental Depression><Mobile Phones><Modern Man><Monitor><Mononitrogen Monoxide><Mucosal Immunity><N,N-dimethylarginine><NO3-><Negotiating><Negotiation><Nitrates><Nitric Oxide><Nitric Oxide Pathway><Nitrites><Nitrogen Monoxide><Nitrogen Protoxide><Nutracort><Nutrition Interventions><Nutritional Interventions><Outcome><Outcome Assessment><Participant><Patient Recruitments><Placebo Control><Placebos><Polymerase Chain Reaction><Population><Predisposition><Preventative strategy><Preventative treatment><Prevention><Prevention approach><Prevention strategy><Preventive strategy><Preventive treatment><Procedures><Proctocort><Production><Productivity><Property><Protein Secretion><Protocol><Protocols documentation><Psychologic Stress><Psychological Factors><Psychological Stress><Psychosocial Factor><Psychosocial Stress><Randomized Controlled Clinical Trials><Reporting><Research><Respiratory Expiration><Respiratory Infections><Respiratory Mucosa><Respiratory Tract Infections><Rhinovirus infection><Risk><Sampling><Severities><Sham Treatment><Signal Transduction><Signal Transduction Systems><Signaling><Site><Social support><Societies><Source><Stress><Students><Supplementation><Susceptibility><Symptoms><Testing><Tissues><Transmission><Universities><Video Recording><Videorecording><Viral><Viral Diseases><Viral Respiratory Tract Infection><Virus Diseases><Visit><adult youth><alleviate symptom><ameliorating symptom><arginase><arginine amidinase><arm><asymmetric dimethylarginine><attenuate><attenuates><biologic><biological signal transduction><canavanase><circulatory system><coronavirus disease 2019><coronavirus disease-19><coronavirus infectious disease-19><cost><cytotoxic><decrease symptom><depression><developed country><developed nation><developed nations><developmental><diet intervention><dietary nitrate><dimethyl-L-arginine><dosage><double-blind placebo control trial><double-blind placebo controlled trial><double-masked controlled trial><endothelial cell derived relaxing factor><evidence base><experience><fewer symptoms><follow up assessment><followup assessment><guanidino-N,N-dimethylarginine><iPhone><infected with Rhinovirus><infection risk><inhibitor><insight><interventional strategy><missing work><new approaches><nitrate><novel><novel approaches><novel strategies><novel strategy><participant recruitment><pathogen><placebo control trial><placebo controlled><placebo controlled trial><prophylactic><psychological defense mechanism><psychosocial variables><public health relevance><pulmonary><randomized control clinical trial><randomized, clinical trials><recruit><reduce symptoms><relieves symptoms><respiratory><sex><sham therapy><smart phone><smartphone><social support network><symptom alleviation><symptom reduction><symptom relief><transmission process><trial design><video recording system><viral infection><viral respiratory infection><viral testing><virus infection><virus testing><virus-induced disease><young adult><young adulthood>