This study is designed to test if consumption of a vegetable extract as a food ingredient improves resistance to an experimental respiratory tract infection with RV16 in healthy volunteers.Primary Objective: * To test and quantify the effect of the…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Severity of symptoms using validated WURSS-21 questionnaire on day -1 to 13
following experimental infection
* Viral titer in nasal lavage
Secondary outcome
* 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
Background summary
Common cold symptoms are unpleasant, dangerous for people with a compromised
immune system, and have a significant economic impact, accounting for millions
of workdays missed annually, worldwide. Enhancing resistance to common cold
infections will generally contribute to wellbeing. In recent proof of concept
studies, a polysaccharide component of certain food crops has been shown to
modulate immune response in a way that suggests it may be effective in
supporting protection against infections.The promising outcomes of these
earlier studies need to be confirmed in a randomized controlled trial, testing
the effect on symptoms in otherwise healthy subjects.
Study objective
This study is designed to test if consumption of a vegetable extract as a food
ingredient improves resistance to an experimental respiratory tract infection
with RV16 in healthy volunteers.
Primary Objective:
* To test and quantify the effect of the vegetable extract on reduction of
severity of common cold symptoms after experimental infection with RV16, as
assessed by the WURSS-21 questionnaire over 13 days following infection
* To test and quantify the effect of a vegetable extract on reduction of viral
load in nasal lavage, after experimental infection with RV16, over 13 days
following infection
Secondary Objectives:
* To test the effect of a vegetable extract on duration of infection based on a
combination of RV16 viral titers, symptoms and elevated IL-8 in nasal lavage
* To test the effect of a vegetable extract on change in IL-8 and IP10 levels
and cell differentials in nasal lavage over 13 days following infection,
compared to pre-infection levels
* To test the effect of a vegetable extract on the increase in phagocyte
activity between baseline and the day before experimental infection
Study design
Randomized, double-blind, placebo-controlled trial with three parallel arms, in
which all groups will be challenged with a low dose of human rhinovirus-16
(HRV-16).
Intervention
Three groups:
placebo
low dose of a vegetable extract
high dose of a vegetable extract
Study burden and risks
Study participants will have no direct benefit from participating. The main
burden for participants is that they will suffer from a common cold episode and
will have to visit the AMC hospital 10 times over a period of 15 weeks.
The RV16 infection protocol has often been used to challenge healthy
individuals, mild (allergic) asthmatics and COPD patients. The rationale for
using RV16 is that this rhinovirus strain causes mild common cold symptoms as
compared to other rhinovirus strains. In addition, RV16 is not considered to be
very contagious. No adverse effects of using RV16 in healthy individuals and
patients have been reported.
Blood samples will be collected 8 times; a nasal lavage will be performed on 6
occasions. Questionnaires have to be completed on 21 days during the study.
Participants will experience the physical discomfort associated with a common
cold episode. The health risks associated with participation are considered to
be minimal.
Bronland 12 N
Wageningen 6708 WH
NL
Bronland 12 N
Wageningen 6708 WH
NL
Listed location countries
Age
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
* 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
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 |
|---|---|
| CCMO | NL62623.018.17 |