Clinical trial NCT05917015: A Clinical Study to Determine if Beta Glucan Reduces the Incidence, Duration or Severity of URTIs Among Skiers
Official title: A Clinical Study to Determine if Beta-glucan Reduces the Incidence, Duration or Severity of Upper Respiratory Tract Infections Among Skiers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Respiratory Tract Infections
Mental Stress
Lead sponsor: USANA Health Sciences
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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:

1. Placebo: daily consumption of the placebo tablet
2. Treatment: daily consumption of the supplement (treatment) tablet

In addition, subjects will complete the WURSS-24 survey daily, and the APSQ survey weekly.

Eligibility criteria: 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.

Primary outcomes:
measure: Upper respiratory tract symptoms
timeFrame: 6 weeks
Secondary outcomes:
measure: Athlete psychological stress
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Park City
country: United States
facility: US Ski and Snowboard Center of Excellence
state: Utah
Study officials:
affiliation: USANA Health Sciences
name: Mark Levy, PhD
role: PRINCIPAL_INVESTIGATOR
References: