A Clinical Study to Determine if Beta Glucan Reduces the Incidence, Duration or Severity of URTIs Among Skiers

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Clinical Study to Determine if Beta-glucan Reduces the Incidence, Duration or Severity of Upper Respiratory Tract Infections Among Skiers

Conditions
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Upper Respiratory Tract Infections, Mental Stress

Intervention / Treatment
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* Dietary Supplement: Treatment
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Treatment<br>a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment | Other: Placebo<br>* Participants will receive daily 2 placebo tablets containing microcrystalline cellulose. The size, shape and appearance of the placebo tablet is identical to the treatment tablet.<br>|
| Experimental: Dietary supplement intervention<br>Participants were treated with 2 beta-glucan containing tablets per day for a total duration of 6 weeks. | Dietary Supplement: Treatment<br>* Participants will receive daily 2 tablets of Proglucamune for a duration of 6 weeks. Each tablet contains  100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes).<br>* Other names: Treatment brand name: Proglucamune (USANA Health Sciences);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper respiratory tract symptoms | The frequency, duration and severity of upper respiratory tract symptoms among study participants will be monitored via a self reported questionnaire administered daily. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Athlete psychological stress | The degree of athlete psychological stress symptoms among study participants will be monitored via a self reported questionnaire administered weekly. | 6 weeks |