Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917015
Status:
RECRUITING
Last Update Posted:
2023-06-23
First Post:
2023-06-14
Brief Title:
A Clinical Study to Determine if Beta Glucan Reduces the Incidence Duration or Severity of URTIs Among Skiers
Sponsor:
USANA Health Sciences
Organization:
USANA Health Sciences
Study Overview
Official Title:
A Clinical Study to Determine if Beta-glucan Reduces the Incidence Duration or Severity of Upper Respiratory Tract Infections Among Skiers
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None