Healthy subjects, common cold, Human Rhinovirus, RCT, immune function, food derived, food ingredient plant fibre Gezonde proef personen, verkoudenheid, humaan rhino virus, RCT, immuunfunctie, voedings ingredient, voedingsvezels
Conditions
Interventions
IMPP-1 vs placebo
Sponsors
NutriLeads
Bronland 12
6708 WH Wageningen
The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 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 •Underlying pulmonary, cardiovascular or auto-immune disease • 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, NIZO 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 usage •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 V1 •Night shift work
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test and quantify the effect of IMPP-1 on: •Reduction of severity of common cold symptoms after experimental infection with RV16, as assessed by the WURSS-21 questionnaire, and on •The reduction of viral load in nasal lavage | — |
Secondary
| Measure | Time frame |
|---|---|
| To test the effect of IMPP-1 on: •Duration of infection based on a combination of RV16 viral titers, symptoms and elevated IL-8 in nasal lavage •Change in IL-8 and IP10 levels and cell differentials in nasal lavage compared to pre-infection levels •The increase in phagocytic activity of granulocytes between baseline and the day before experimental infection | — |
Contacts
Public ContactDave Marsen-Veldhuis
Outcome results
None listed