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

June 14, 2023 updated by: Mark Levy, USANA Health Sciences

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.
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:
  • Treatment brand name: Proglucamune (USANA Health Sciences)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper respiratory tract symptoms
Time Frame: 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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Athlete psychological stress
Time Frame: 6 weeks
The degree of athlete psychological stress symptoms among study participants will be monitored via a self reported questionnaire administered weekly.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USANA Health Sciences

Investigators

  • Principal Investigator: Mark Levy, PhD, USANA Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202206CT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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