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

NCT ID: NCT05917015

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2023-12-31

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.

Conditions

Upper Respiratory Tract Infections; Mental Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo Treatment

a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Dietary supplement intervention

Participants were treated with 2 beta-glucan containing tablets per day for a total duration of 6 weeks.

Group Type: EXPERIMENTAL

Treatment

Intervention Type: DIETARY_SUPPLEMENT

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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

Treatment brand name: Proglucamune (USANA Health Sciences)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USANA Health Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Mark Levy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Levy, PhD

Role: PRINCIPAL_INVESTIGATOR

USANA Health Sciences

Locations

US Ski and Snowboard Center of Excellence

Park City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark Levy

Role: CONTACT

mark.levy@usanainc.com

801 954 7783

Facility Contacts

Per Lundstam

Role: primary

per.lundstam@usskiandsnowboard.org

435-571-1813

Other Identifiers

202206CT

Identifier Type: -

Identifier Source: org_study_id