Investigation on the effect of food crop derived food supplements on common cold infections in healthy volunteers
Recruiting
- Conditions
- Healthy subjects, common cold, Human Rhinovirus, RCT, immune function, food derived, food ingredient plant fibre<br /><br />Gezonde proef personen, verkoudenheid, humaan rhino virus, RCT, immuunfunctie, voedings ingredient, voedingsvezels
- Registration Number
- NL-OMON29458
- Lead Sponsor
- utriLeads<br>Bronland 12 <br>6708 WH Wageningen <br>The Netherlands
- Brief Summary
none
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 168
Inclusion Criteria
1.Age ≥18 and ≤65 years of age
2. Sero-negative (≤ 1:6) to HRV-16 at screening
Exclusion Criteria
•History of hay fever and rhino-sinusitis
•History of asthma or COPD
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To test and quantify the effect of IMPP-1 on:<br /><br>•Reduction of severity of common cold symptoms after experimental infection with RV16, as assessed by the WURSS-21 questionnaire, and on <br /><br>•The reduction of viral load in nasal lavage<br><br>
- Secondary Outcome Measures
Name Time Method To test the effect of IMPP-1 on: <br /><br>•Duration of infection based on a combination of RV16 viral titers, symptoms and elevated IL-8 in nasal lavage<br /><br>•Change in IL-8 and IP10 levels and cell differentials in nasal lavage compared to pre-infection levels <br /><br>•The increase in phagocytic activity of granulocytes between baseline and the day before experimental infection<br><br>