search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Investigation on the effect of food crop derived food supplements on common cold infections in healthy volunteers


- candidate number28087
- NTR NumberNTR6773
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-okt-2017
- Secondary IDsNutriLeads HO2 NL62623.018.17
- Public TitleInvestigation on the effect of food crop derived food supplements on common cold infections in healthy volunteers
- Scientific TitleHuman Exposure to RhinOvirus – Effect of a plant polysaccharide food supplement on upper respiratory symptoms
- ACRONYMHERO Reborn Study
- hypothesisCommon 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
- Healt Condition(s) or Problem(s) studiedCommon cold, Rhinovirus, Immune function, Food ingredient
- Inclusion criteria1.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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-nov-2017
- planned closingdate27-sep-2018
- Target number of participants168
- InterventionsIMPP-1 vs placebo
- Primary outcomeTo 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 outcomeTo 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
- TimepointsSeverity 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
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. Dave Marsen-Veldhuis
- CONTACT for SCIENTIFIC QUERIESDr. René Lutter
- Sponsor/Initiator NutriLeads
- Funding
(Source(s) of Monetary or Material Support)
Europees Fonds voor Regionale Ontwikkeling, NutriLeads
- Publicationsnone
- Brief summaryCommon 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
- Main changes (audit trail)
- RECORD26-okt-2017 - 5-nov-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl