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

NCT05917015 | Unknown

• 1 other identifier: 202206CT
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Upper Respiratory Tract Infections; Mental Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Athlete psychological stress

  6 weeks

Study Arms (2)

Placebo Treatment

PLACEBO COMPARATOR

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

Other: Placebo

Dietary supplement intervention

EXPERIMENTAL

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

Dietary Supplement: Treatment

Interventions

Treatment 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).

Also known as: Treatment brand name: Proglucamune (USANA Health Sciences)

Dietary supplement intervention

Placebo 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.

Placebo Treatment

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• USANA Health Sciences: lead

Study Sites (1)

US Ski and Snowboard Center of Excellence

Park City, Utah, 84060, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; Stress, Psychological

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Behavioral Symptoms; Behavior

Study Officials

• Mark Levy, PhD

  USANA Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Levy

CONTACT

801 954 7783; mark.levy@usanainc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: March 6, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

US (1)