No registrations found.
ID
Source
Brief title
Health condition
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
Sponsors and support
Bronland 12 <br>
6708 WH Wageningen <br>
The Netherlands
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Common colds have a significant impact on individuals, health care and economy. Functional food ingredients can reduce incidence, duration and severity of common respiratory tract infections in healthy elderly and adults. We hypothesize that test product NutrL-c02, which is an extract from foodcrops enriched for IMPP-1, a compound that supports innate immune function, increases resistance to an experimental infection with RV16, which mimics natural common colds.
The study will be a double blind, placebo-controlled randomized trial with three arms, two doses of IMPP-1 and placebo, in healthy individuals. Healthy adults (men and women) from the general population between 18 and 65 years of age. Per arm 56 participants recruited in the Netherlands
Study objective
Common colds have a significant impact on individuals, health care and economy. Functional food ingredients can reduce incidence, duration and severity of common respiratory tract infections in healthy elderly and adults. We hypothesize that test product NutrL-c02, which is an extract from food crops enriched for IMPP-1, a compound that supports innate immune function, increases resistance to an experimental infection with RV16, which mimics natural common colds
Study design
Severity of symptoms using validated WURSS-21 questionnaire(AUC of total symptom scores) on day -1 to 13 around experimental infection with RV16 on day 0 and viral titer in nasal lavage.
Blood samples for immunological markers are taken on day: -55 (baseline start of dietary intervention), -1, 3, 6, 9 & 13 after the RSV challenge
Intervention
IMPP-1 vs placebo
Bronland 12
Wageningen 6708 WH
The Netherlands
0031(0)682362822
Dave.marsen@nutrileads.com
Bronland 12
Wageningen 6708 WH
The Netherlands
0031(0)682362822
Dave.marsen@nutrileads.com
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
•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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6559 |
| NTR-old | NTR6773 |
| Other | NL62623.018.17 : NutriLeads HO2 |