A Clinical Study to Determine if Beta Glucan Reduces the Incidence, Duration or Severity of URTIs Among Skiers
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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:
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Placebo: daily consumption of the placebo tablet
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Treatment: daily consumption of the supplement (treatment) tablet
In addition, subjects will complete the WURSS-24 survey daily, and the APSQ survey weekly.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Treatment a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment |
Other: Placebo
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.
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| Experimental: Dietary supplement intervention Participants were treated with 2 beta-glucan containing tablets per day for a total duration of 6 weeks. |
Dietary Supplement: Treatment
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).
Other Names:
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Outcome Measures
Primary Outcome Measures
- Upper respiratory tract symptoms [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.
Secondary Outcome Measures
- Athlete psychological stress [6 weeks]
The degree of athlete psychological stress symptoms among study participants will be monitored via a self reported questionnaire administered weekly.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provide informed consent by signing the electronic Information and Consent Form.
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Male or females between the ages of 18 and 30 (inclusive) without regard to race or ethnic background
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Are in generally good health and have no medical conditions that would prevent or interfere with their participation in the study
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Are fully able and willing to comply with the requirements of the study
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Are fully able and willing to keep scheduled appointments
Exclusion Criteria:
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Females that are pregnant, attempting to become pregnant or are currently lactating/nursing a child.
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Individuals currently taking prescription medications that are known to be immunosuppressants (e.g. dexamethasone, tacrolimus, methotrexate)
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Individuals with gastrointestinal conditions (e.g., inflammatory bowel disease, Crohn's disease, etc.) that may affect consumption of the treatment supplements.
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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.
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Individuals with a recent history of cancer other than non-melanoma skin cancer.
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Individual's that have trouble swallowing pills.
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Individuals that have participated as a subject in any other clinical study within 30 days of screening.
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Individuals with a history of alcohol abuse or other substance abuse within the previous 2 years.
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Individuals that currently use tobacco products including chewing tobacco and cigarettes.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | US Ski and Snowboard Center of Excellence | Park City | Utah | United States | 84060 |
Sponsors and Collaborators
- USANA Health Sciences
Investigators
- Principal Investigator: Mark Levy, PhD, USANA Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202206CT