Beetroot Juice Supplement for Boosting Mucosal Immunity – The NO Cold Study

甜菜根汁补充剂可增强粘膜免疫力 — NO 感冒研究

基本信息

批准号：
10645991
负责人：
Thomas Ekkehard Ritz
金额：
$ 51.88万
依托单位：
SOUTHERN METHODIST UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-23 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10645991
关键词：
Absenteeism at work Adherence Adverse effects Attenuated Biological Buffers COVID-19 Cardiovascular system Cellular Phone Cessation of life Chronic stress Clinical Trials Common Cold Cytostatics Data Defense Mechanisms Dependence Developed Countries Development Dietary Intervention Dose Double-Blind Method Economic Burden Epithelial Cells Exercise Physiology Exhalation Feasibility Studies Healthcare Systems Hour Human Hydrocortisone Infection Intake Intervention Juice Life Stress Link Lung Measures Mediation Medicine Mental Depression Monitor Mucosal Immunity N,N-dimethylarginine Nitrates Nitric Oxide Nitric Oxide Pathway Nitrites Outcome Outcome Assessment Participant Patient Recruitments Placebo Control Placebos Polymerase Chain Reaction Population Predisposition Prevention Prevention approach Prevention strategy Preventive treatment Procedures Production Productivity Property Protein Secretion Protocols documentation Psychological Factors Psychological Stress Psychosocial Factor Psychosocial Stress Randomized Controlled Clinical Trials Reporting Research Respiratory Mucosa Respiratory Tract Infections Rhinovirus infection Risk Sampling Severities Signal Transduction Site Social support Societies Source Stress Students Supplementation Symptoms Testing Tissues Universities Video Recording Viral Viral Respiratory Tract Infection Virus Diseases Visit arginase arm cost cytotoxic dietary nitrate dosage double-blind placebo controlled trial evidence base experience follow up assessment infection risk inhibitor insight novel novel strategies pathogen placebo controlled trial prophylactic public health relevance randomized, clinical trials recruit reduce symptoms respiratory sex transmission process trial design young adult

项目摘要

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.

概括呼吸道感染给整个医疗保健系统和社会带来了重大负担，这对Covid-19却激怒了。可用的预防性治疗呼吸道感染和普通感冒仍然不令人满意，并且通常不遵守。心理因素（例如压力）增加了呼吸道感染和普通感冒的风险。这种关系的可能机制可以降低一氧化氮水平（NO），该水平是一线防御机制。在心理压力期间，诸如学生的学术决赛时期都会减少NO。在压力期间提高NO水平可能会为呼吸道感染提供预防策略，尤其是在具有高传播风险的人群中。我们的试点数据表明，甜菜根汁可以提高呼气NO（FENO）的比例，并减轻了压力性最终考试期间的冷症状。 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聚合酶链反应。当前的研究将1）证明，每天的甜菜根汁或去硝化的安慰剂甜菜根汁是可行的，在现实压力期间具有可接受的依从性，可接受的依从性，2）产生对贝甜果汁在Feno中增加呼应的能力的初步证据，与Feno的降低相关，这与3）相关，该呼吸道与呼吸道相关，这是3），这是3），这是3）病毒式的病毒性，（3）与病毒性相关，（（效果，因为在抬高feno时，每天两次活跃的甜菜根汁可能比每日剂量或安慰剂更有效。该试验将使用自然压力的良好控制范式来证明，气道没有生产是饮食中硝酸盐补充饮食对呼吸道感染和常见冷症状的有益作用的关键目标机制。两个大学站点将招募参与者，他们在团队一体化方面的发现和经验将准备针对呼吸道感染的甜菜根果汁效应的常规大小的双盲型随机对照临床试验，其中包括美国西南部各地的其他招聘站点。