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

Last updated: June 14, 2023
Sponsor: USANA Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Stress

Treatment

Treatment

Placebo

Clinical Study ID

NCT05917015
202206CT
  • Ages 18-30
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 orethnic background
  • Are in generally good health and have no medical conditions that would prevent orinterfere 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

Exclusion Criteria:

  • Females that are pregnant, attempting to become pregnant or are currentlylactating/nursing a child.
  • Individuals currently taking prescription medications that are known to beimmunosuppressants (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 diabeticswill 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 30days of screening.
  • Individuals with a history of alcohol abuse or other substance abuse within theprevious 2 years.
  • Individuals that currently use tobacco products including chewing tobacco andcigarettes.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Treatment
Phase:
Study Start date:
March 06, 2023
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • US Ski and Snowboard Center of Excellence

    Park City, Utah 84060
    United States

    Active - Recruiting

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