Back to resultsA Clinical Study to Determine if Beta Glucan Reduces the Incidence, Duration or Severity of URTIs Among Skiers
Primary Purpose
Upper Respiratory Tract Infections, Mental Stress
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Tract Infections
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.
Sites / Locations
- US Ski and Snowboard Center of ExcellenceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo Treatment
Dietary supplement intervention
Arm Description
a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment
Participants were treated with 2 beta-glucan containing tablets per day for a total duration of 6 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Athlete psychological stress
The degree of athlete psychological stress symptoms among study participants will be monitored via a self reported questionnaire administered weekly.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05917015
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USANA Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Placebo: daily consumption of the placebo tablet
Treatment: daily consumption of the supplement (treatment) tablet
In addition, subjects will complete the WURSS-24 survey daily, and the APSQ survey weekly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections, Mental Stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo Treatment
Arm Type
Placebo Comparator
Arm Description
a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment
Arm Title
Dietary supplement intervention
Arm Type
Experimental
Arm Description
Participants were treated with 2 beta-glucan containing tablets per day for a total duration of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Treatment
Other Intervention Name(s)
Treatment brand name: Proglucamune (USANA Health Sciences)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper respiratory tract symptoms
Description
The frequency, duration and severity of upper respiratory tract symptoms among study participants will be monitored via a self reported questionnaire administered daily.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Athlete psychological stress
Description
The degree of athlete psychological stress symptoms among study participants will be monitored via a self reported questionnaire administered weekly.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Levy
Phone
801 954 7783
Email
mark.levy@usanainc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Levy, PhD
Organizational Affiliation
USANA Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Ski and Snowboard Center of Excellence
City
Park City
State/Province
Utah
ZIP/Postal Code
84060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Lundstam
Phone
435-571-1813
Email
per.lundstam@usskiandsnowboard.org
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Determine if Beta Glucan Reduces the Incidence, Duration or Severity of URTIs Among Skiers
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