Common cold, Healthy senior subjects, Immune function, Food ingredient, ARTI, Flu
Conditions
Interventions
NL-01 low dose, NL-01 high dose vs placebo
Sponsors
NutriLeads
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be able to give written informed consent; 2. Be aged ≥65 years; 3. Have a General Practitioner; 4. Be in good physical and mental condition;
Exclusion criteria
Exclusion criteria: 1.Are hypersensitive to any of the components of the test product; 2.Have a history (within 5 years) of drug and/or alcohol abuse at the time of enrolment; 3.Are planning extensive travel (maximum of 3 consecutive weeks) over the duration of the study; 4.Have language limitations regarding interviews and questionnaires; 5.Are a resident of a nursing home or on a waiting list for a nursing home; 6.Have a psychiatric disease, gastrointestinal disease (i.e., coeliac disease, Inflammatory Bowel Disease), Rheumatoid arthritis, dementia, cancer, or other diseases deemed significant at the discretion of the study physician; 7.Have a history of significant medical or psychiatric disease, at the discretion of the study physician; 8.Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid treatment for >30 days, or had chemotherapy within the last year); 9. Suffer from an unfavourable physical or mental condition at the discretion of the study physician (i.e. not going to survive the study); 10. Exhibit a deterioration of medical condition or disease, which at the discretion of the study physician, may require withdrawal from the study; 11. Are a NutriLeads or Site employees; 12.Use any other medication at the discretion of the study physician which could impact the overall objectives of the study; 13.Have , or ≤1 year had, a malignant disease (with the exception of basal cell carcinoma) or any concomitant end-stage organ disease; Subjects diagnosed with cancer that significantly reduces life expectancy (i.e. terminal) will be removed from the study, at the discretion of the study physician; 14.Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial; 15. Individual who receive immuno-, radio- or chemo- therapy; 16.Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these latter must have been completed not less than 60 days prior to this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Number of Acute Respiratory Tract Infections (ARTI) episodes -Average duration of ARTI episodes in days -Average severity of ARTI episodes | — |
Secondary
| Measure | Time frame |
|---|---|
| -Doctor / hospital visits, -Any infection occurring in the treatment period, -Any medication use related to infections, -Calculated disease load of ARTI per study arm (#episodes x duration of episodes), -Incidence and disease load (episodes x duration) of any kind of infection, -Indication of efficacy per defined sub-population (e.g. malnourished, on medical foods, COPD etc), -Quality of Life questionnaire (5Q-5D-5L questionnaire). | — |
Contacts
Public ContactRuud Albers
NutriLeads
Outcome results
None listed