Human Exposure to RhinOvirus * Effect of a plant-based polysaccharide food supplement on upper respiratory symptoms
- Conditions
- common cold10047438acute rhinitis10024970
- Registration Number
- NL-OMON44493
- Lead Sponsor
- utrileads B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 168
Healthy adults (men and women) from the general population
1. Age *18 and *65 years of age
2. Sero-negative (* 1:6) to HRV-16 at screening
3. Body mass index (BMI) * 18.5 and * 30.0 kg/m2
4. Healthy (assessed by study physician, based on medical history and used medication as provided by the participant)
5. Willingness to comply with study procedures
6. Having a GP
7. Signed informed consent
* History of hay fever and rhino-sinusitis
* History of asthma or COPD
* History of food allergy or food intolerance
* Underlying pulmonary, cardiovascular or auto-immune disease
Use of statins
* History of significant medical or psychiatric disease, at the discretion of the study physician
* Pregnant or intending to become pregnant during the study period and lactating women
* Frequent contact with elderly, immune deficient or severe asthma/COPD patients or children under the age of 2 years during the course of the trial
* NutriLeads or AMC employee of departments of Respiratory Medicine and Experimental Immunology
* Current or ex-smoker (last half year)
* Consumption of > 14 alcoholic units in a typical week (females) or > 21 alcoholic units in a typical week (males)
* Strenuous exercise (> 10 hrs/wk)
* Any other medication at the discretion of the study physician
* Recreational drug abuse
* Language limitations regarding interviews and questionnaires
* Volunteers who share the same house(hold)
* Currently participating in another clinical trial
* Reported, unexplainable weight loss or gain >3 kg in the last month before screening visit
* Night shift worker
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Severity of symptoms using validated WURSS-21 questionnaire on day -1 to 13<br /><br>following experimental infection<br /><br>* Viral titer in nasal lavage</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Duration of infection based on combination of RV16 viral titers, symptoms and<br /><br>elevated IL8 in nasal lavage<br /><br>* Change in IL-8 and IP10 levels in nasal lavage<br /><br>* Increase in phagocyte activity between baseline and day before infection</p><br>