adults. We hypothesize that test product NL-01, which is an extract from food crops enriched for IMPP-1, a compound that supports innate immune function, increases resistance to acute respiratory tract infections (ARTI) in the winter season
ID
Bron
Verkorte titel
Aandoening
Common cold, Healthy senior subjects, Immune function, Food ingredient, ARTI, Flu
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
-Number of Acute Respiratory Tract Infections (ARTI) episodes<br>
-Average duration of ARTI episodes in days<br>
-Average severity of ARTI episodes
Achtergrond van het onderzoek
Globally, acute respiratory tract infections are the most common of all illnesses; they are generally caused by rhinovirus, adenovirus, coronavirus, and influenza. Influenza is associated with the most severe respiratory viral illness (RVI), but rhinoviruses—which manifest as the common cold—cause the greatest number of RVIs. Frequently these RVI are followed by a secondary infection that can lead to pulmonary infections, like pneumonia. Individuals that are ≥ 65 years have increased susceptibility to airway infections especially those who have lower humoral and cellular immunity, impaired physiologic function, impaired mobility, co-morbidities, or immunosuppression. Every year, during the cold season, health care professionals need to spend much of their time on the diagnosis and treatment of elderly subjects with respiratory infections and this group is over-represented on the first aid department of hospitals which, in some cases, causes them to put a stop on admission in the influenza peak season. Significant reduction of the number or duration of ARTI episodes would be of great benefit for subjects with increased risk of respiratory tract infections and for the health care system as a whole. There is a clear consumer demand for food products that can help support immune function and increase resistance to ARTI. NL-01 is an innovative proprietary Health Ingredient that supports immune function and is postulated to improve resistance to ARTI.
Doel van het onderzoek
adults. We hypothesize that test product NL-01, which is an extract from food crops enriched for IMPP-1, a compound that supports innate immune function, increases resistance to acute respiratory tract infections (ARTI) in the winter season
Onderzoeksopzet
Severity of symptoms using validated WURSS-24 questionnaire. Subjects will have 4 on site visits and HCP home visit to confirm any 'cold' episode.
On visit 1,2,3 &4 blood samples will be taken for immune markers and safety.
Onderzoeksproduct en/of interventie
NL-01 low dose, NL-01 high dose vs placebo
Publiek
Ruud Albers
NutriLeads Bronland 12-N
Wageningen 6708 WH
The Netherlands
+31 6 12 50 07 64
ruud.albers@nutrileads.com
Wetenschappelijk
Ruud Albers
NutriLeads Bronland 12-N
Wageningen 6708 WH
The Netherlands
+31 6 12 50 07 64
ruud.albers@nutrileads.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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;
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7111 |
NTR-old | NTR7316 |
Ander register | REC 18/ES/0069 IRAS #247195 : Nutrileads H03- AFCRO-090 |