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

Not Applicable

Recruiting

• Conditions: Upper Respiratory Tract Infections; Mental Stress
• Interventions: Dietary Supplement: Treatment; Other: Placebo

• Registration Number: NCT05917015
• Lead Sponsor: USANA Health Sciences

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.

Study Timeline

• Study Start: 2023-03-06
• Status Verified: 2023-06
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-14
• Study First Posted: 2023-06-23
• Last Update Posted: 2023-06-23
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary supplement intervention	Treatment	Participants were treated with 2 beta-glucan containing tablets per day for a total duration of 6 weeks.
Placebo Treatment	Placebo	a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

US Ski and Snowboard Center of Excellence; 🇺🇸 Park City, Utah, United States