acute rhinitis common cold
Conditions
Interventions
Three groups:
placebo
low dose of a vegetable extract
high dose of a vegetable extract
Sponsors
Nutrileads B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Severity of symptoms using validated WURSS-21 questionnaire on day -1 to 13 following experimental infection * Viral titer in nasal lavage | — |
Secondary
| Measure | Time frame |
|---|---|
| * Duration of infection based on combination of RV16 viral titers, symptoms and elevated IL8 in nasal lavage * Change in IL-8 and IP10 levels in nasal lavage * Increase in phagocyte activity between baseline and day before infection | — |
Countries
Netherlands
Outcome results
None listed