Upper Respiratory Tract InfectionsNCT05917015
A Clinical Study to Determine if Beta Glucan Reduces the Incidence, Duration or Severity of URTIs Among Skiers
A study testing Treatment in people with Upper Respiratory Tract Infections and Mental Stress, run by USANA Health Sciences at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections, Mental Stress
- What is being tested?
- Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
US Ski and Snowboard Center of Excellence
Park City, Utah, 84060
Per Lundstam, 435-571-1813, per.lundstam@usskiandsnowboard.org
About this study
Official title: 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
Read the 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.
- Conditions
- Upper Respiratory Tract Infections, Mental Stress
- Being tested
- Treatment, Placebo
- Medical subject headings
- Respiratory Tract Infections, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDietary supplement
Also called Treatment brand name: Proglucamune (USANA Health Sciences)
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).
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Treatment | Placebo comparator | a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment Receives: Other: Placebo |
| Dietary supplement intervention | Experimental | Participants were treated with 2 beta-glucan containing tablets per day for a total duration of 6 weeks. Receives: Dietary Supplement: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Athlete psychological stress
The degree of athlete psychological stress symptoms among study participants will be monitored via a self reported questionnaire administered weekly.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start6 Mar 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USANA Health Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mark Levy, USANA Health Sciences
- Investigators
- Mark Levy, PhD, Principal investigator, USANA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917015
- Sponsor's protocol ID
- 202206CT
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Determine if Beta-glucan Reduces the Incidence, Duration or Severity of Upper Respiratory Tract Infections Among Skiers
- ClinicalTrials.gov ID
- NCT05917015
- Acronym / sponsor ID
- 202206CT
- Conditions
- Upper Respiratory Tract Infections, Mental Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- USANA Health SciencesIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Treatment | Placebo comparator | Other: Placeboa placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment |
| Dietary supplement intervention | Experimental | Dietary Supplement: TreatmentParticipants were treated with 2 beta-glucan containing tablets per day for a total duration of 6 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentAlso: Treatment brand name: Proglucamune (USANA Health Sciences)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). | Dietary supplement | Dietary supplement intervention |
| PlaceboParticipants will receive daily 2 placebo tablets containing microcrystalline cellulose. The size, shape and appearance of the placebo tablet is identical to the treatment tablet. | Other | Placebo Treatment |
Primary outcome
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.
1 secondary outcome
Athlete psychological stress
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Levy, PhD principal investigator
USANA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Upper Respiratory Tract Infections and Mental Stress, run by USANA Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Levy (801 954 7783, mark.levy@usanainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper respiratory tract symptoms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.