A Randomised Controlled Trial to assess a food supplement (baker’s yeast extract) to support immune function and prevent cold and flu symptoms in a 50 to 70 year old populatio
- Conditions
- We aim to assess the number and severity of Upper Respiratory Tract Infection(URTI)Symptoms reported by participants over a 90 day period commencing in January 2012 in 100 healthy 50-70 year olds pre-screened to exclude symptomatic chronic respiratory or cardiac disease. We will also assess between group difference in immune function measuring LPS-stimulated cytokine and chemokine data and salivary immunoglobulins.Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-004910-41-GB
- Lead Sponsor
- niversity of Southampton
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
•Age 50-70 years •general good health •BMI 18-40 •consent to all study visits and procedures •community-dwelling •at least 1 self-reported cold in the last 12 months
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
• current symptomatic respiratory illness • current oral steroids use • current antibiotic or immunosuppressant medication • known immune or auto-immune disorders (including HIV, ankylosing spondylitis, Crohn’s Disease, Ulcerative Colitis) • low BMI/ eating disorders • severe renal or liver disease • symptomatic heart failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method