Beetroot Juice Supplement for Boosting Mucosal Immunity - The NO Cold Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Exhaled Nitric Oxide
研究概览
简要总结
Currently, there is a lack of evidence-based prevention strategies for respiratory infection and management of these conditions can be costly to the public. Airway nitric oxide provides a first line of defense against pathogens, and beetroot juice, a source of dietary nitrate, has been shown to elevate nitric oxide. The main objective of this project is to demonstrate that one week of supplementation with beetroot juice elevates airway nitric oxide during stressful periods in young adults and thereby can protect against respiratory viral infections.
详细描述
Study Title Beetroot Juice Supplement for Boosting Mucosal Immunity: The NO Cold Study
Objectives Aim 1: Demonstrate that a 7-day trial of daily beetroot juice or nitrate depleted placebo beetroot juice is feasible with acceptable retention and adherence during a period of real-life stress, using adherence monitoring of beetroot juice intake by cell phone recorded video; acceptable burdensomeness for participants and success of team coordination and study logistics should also be demonstrated.
Aim 2: Generate initial estimates of effect size for a) elevations in exhaled nitric oxide (FENO) and b) the correlation between changes in FENO and both infection reduction and cold symptom reduction (biological signature).
Aim 3: a) Examine if 2 daily doses of beetroot juice are more potent than 1 daily dose in elevating FENO, and b) investigate whether each beetroot juice dosage (1 dose and 2 doses) increases FENO more than the placebo.
Exploratory aims: Explore sex as a moderator of all the Aims. Also explore effects of competitors/inhibitors of NO (arginase, asymmetric dimethylarginine) in a) reducing FENO under stress, and b) whether beetroot juice buffers any of these potential adverse effects on FENO; c) investigate whether effects of stress cortisol, which negatively impact NO, cold symptoms, and respiratory infections, are also buffered by beetroot juice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both participating students and assessors will be blinded to the participants' group assignment. Since students and research staff will not know whether their beetroot juice is depleted or not, treatment conditions are double-blinded (juice "shots" will be pre-labeled by study statistician with a participant number based on the pre-study randomization, so neither the staff nor the participant know the contents). Students will also be assured of full blinding of course instructors, including the PIs and Co-Is, to names of study participants.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals will be included:
- •SMU or Baylor University students
- •Ages of 18-30 years old.
排除标准
- •Active smokers
- •Smoking cannabis or vape
- •Students with clinically significant asthma
- •COPD and emphysema
- •Allergic rhinitis
- •High levels of exhaled nitric oxide (FENO ≥40ppb)
- •Developing kidney stone
- •Clinically significant heart disease
- •Cerebrovascular disease
- •Thyroid dysfunction
- •Out-of-control diabetes
- •Significant current problems with schizophrenia, psychosis, mood disorders, suicidality, and drug or alcohol dependence or abuse
结局指标
主要结局
Exhaled Nitric Oxide
时间窗: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
The Fraction of NO in Exhaled Breath (FENO, in ppb) will be measured with an electrochemical gas analyzer (NIOX vero).
Wisconsin Upper Respiratory Symptom Survey (WURSS)
时间窗: Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period), 1-3 days after finishing beetroot shots (after final examinations)
Assess symptoms of acute upper respiratory tract infections (common cold symptoms) by questionnaire
Viral Polymerase Chain Reaction
时间窗: Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period)
Binary positive/negative test results for a panel of viral and bacterial respiratory pathogens.
Adherence monitoring (feasibility)
时间窗: Every day during active beetroot shots (Days 1-7)
Participants will upload a cell phone video of their intake for that day to a secure cloud folder, time stamp in comparison to assigned intake windows provides measure of adherence
Burdensomeness
时间窗: 1-3 days after finishing beetroot shots (after final examinations)
Follow-up questionnaire will be administered with the online follow-up survey. It explores experience with the best mode of reminder receipt (email or text message), whether the participants guessed their condition, and how burdensome 8 aspects of the study (including daily intake, video recording, upload, questionnaires, physiological assessment) were.
次要结局
- Perceived stress(Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period))
- Blood pressure (systolic and diastolic blood pressure) and heart rate(Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period))
- Mood(Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period))
- Cortisol(Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period))
- Acute stress(Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period), 1-3 days after finishing beetroot shots (after final examinations))
研究者
Thomas Ritz
Professor
Southern Methodist University