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

• 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
• 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

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.

总结 呼吸道感染对医疗保健系统和整个社会造成了相当大的负担，COVID-19加剧了这种负担。呼吸道感染和普通感冒的现有预防性治疗仍然不能令人满意，而且往往没有得到遵守。压力等心理因素会增加呼吸道感染和普通感冒的风险。这种关系的一个可能机制可能是降低一氧化氮（NO）水平，这是一种第一线防御机制。NO在心理压力期间减少，例如学生的学术期末考试。在压力期间提高NO水平可能为呼吸道感染提供预防策略，特别是在具有高传播风险的人群中。我们的试验数据表明，甜菜根汁提高了呼出的NO（FENO）的分数，并在紧张的期末考试期间减弱了感冒症状。目前的研究提出了一个三臂，双盲，安慰剂对照试验设计（条件：每日一次活性剂量和每日一次安慰剂剂量，每日两次活性剂量，每日两次安慰剂剂量，每种条件下50名参与者，总N=150），学生处于期末考试压力下，通过FENO检测甜菜根汁在升高气道NO中的有效性，从而通过病毒聚合酶链反应检测减少呼吸道病毒感染。本研究将1）证明每日甜菜根汁或脱硝安慰剂甜菜根汁的7天试验在逻辑上是可行的，并且在现实生活压力期间具有可接受的依从性，2）产生甜菜根汁增加FENO升高的能力的初步证据，其与使用呼吸道病毒面板的感染减少相关，（生物特征），3）检查剂量效应，因为甜菜根汁的两个每日活性剂量在升高FENO方面可能比一个每日剂量或安慰剂更有效。该试验将使用一种自然压力的良好控制范例来证明气道NO产生是膳食硝酸盐补充剂对呼吸道感染和普通感冒症状有益作用的关键靶机制。两所大学将招募参与者，他们在团队整合方面的发现和经验将准备一项常规规模的双臂，双盲随机对照临床试验，研究甜菜根汁对呼吸道感染的影响，其中将包括美国西南部的其他招募地点。