A Clinical Study to Determine if Beta-glucan Reduces the Incidence, Duration or Severity of Upper Respiratory Tract Infections Among Skiers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Upper respiratory tract symptoms
研究概览
简要总结
This study is designed to determine if a dieatary supplement containing beta-glucan can reduce the incidence, severity and duration of upper respiratory tract infections among a group of highly trained athletes
详细描述
In this study, we hypothesize that consumption of 200 mg beta-glucan per day will lessen the frequency, duration and severity of URTI symptoms in a population of elite, internationally competitive skiers over a 45-day period. In order to complete this objective, we will utilize the Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) to monitor and quantify the incidence, duration and severity of URTI symptoms. A secondary objective is to determine if beta-glucan supplementation reduces or mitigates early indictors of athlete-specific stress. This objective will be assessed using the Athlete Psychological Strain Questionnaire (APSQ), a 10-question patient-reported outcome tool used to evaluate athlete-specific psychological stress.
This will be a randomized, double blind, placebo controlled, parallel arm design conducted over a 6-week period. 50-60 healthy subjects will be recruited and randomized in a 1:1 ratio to either of two interventions:
- Placebo: daily consumption of the placebo tablet
- Treatment: daily consumption of the supplement (treatment) tablet
In addition, subjects will complete the WURSS-24 survey daily, and the APSQ survey weekly.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Provide informed consent by signing the electronic Information and Consent Form.
- •Male or females between the ages of 18 and 30 (inclusive) without regard to race or ethnic background
- •Are in generally good health and have no medical conditions that would prevent or interfere with their participation in the study
- •Are fully able and willing to comply with the requirements of the study
- •Are fully able and willing to keep scheduled appointments
排除标准
- •Females that are pregnant, attempting to become pregnant or are currently lactating/nursing a child.
- •Individuals currently taking prescription medications that are known to be immunosuppressants (e.g. dexamethasone, tacrolimus, methotrexate)
- •Individuals with gastrointestinal conditions (e.g., inflammatory bowel disease, Crohn's disease, etc.) that may affect consumption of the treatment supplements.
- •Individuals with clinically important renal, hepatic, cardiac pulmonary, pancreatic, neurologic or biliary disorders; insulin-dependent and orally controlled diabetics will also be excluded from the study.
- •Individuals with a recent history of cancer other than non-melanoma skin cancer.
- •Individual's that have trouble swallowing pills.
- •Individuals that have participated as a subject in any other clinical study within 30 days of screening.
- •Individuals with a history of alcohol abuse or other substance abuse within the previous 2 years.
- •Individuals that currently use tobacco products including chewing tobacco and cigarettes.
结局指标
主要结局
Upper respiratory tract symptoms
时间窗: 6 weeks
The frequency, duration and severity of upper respiratory tract symptoms among study participants will be monitored via a self reported questionnaire administered daily.
次要结局
- Athlete psychological stress(6 weeks)
研究者
Mark Levy
Principal Investigator
USANA Health Sciences