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

Upper Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917015
• Other study ID #: 202206CT
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: USANA Health Sciences
• Contact: Mark Levy
• Phone: 801 954 7783
• Email: mark.levy[@]usanainc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Mental Stress
• Respiratory Tract Infections
• Stress, Psychological
• Upper Respiratory Tract Infections

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	US Ski and Snowboard Center of Excellence	Park City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
USANA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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