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van CCT (UK)

van CCT (UK)

Investigation on the effect of food crop derived food supplements on Acute Respiratory Tract Infections in community dwelling seniors during the winter season

- candidate number29079
- NTR NumberNTR7316
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jun-2018
- Secondary IDsNutrileads H03- AFCRO-090 REC 18/ES/0069 IRAS #247195
- Public TitleInvestigation on the effect of food crop derived food supplements on Acute Respiratory Tract Infections in community dwelling seniors during the winter season
- Scientific TitleEfficacy and tolerability of NL-01, a food ingredient, in older adults (≥65 y) at risk of Acute Respiratory Tract Infections (ARTI) during the winter season
- ACRONYMIMPPetus study
- hypothesisadults. 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
- Healt Condition(s) or Problem(s) studiedAcute Respiratory Tract Infections, Flu, Healthy elderly , Immune function
- Inclusion criteria1. 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 criteria1.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;
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-jul-2018
- planned closingdate30-jun-2019
- Target number of participants600
- InterventionsNL-01 low dose, NL-01 high dose vs placebo
- Primary outcome-Number of Acute Respiratory Tract Infections (ARTI) episodes
-Average duration of ARTI episodes in days
-Average severity of ARTI episodes
- Secondary outcome-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).
- TimepointsSeverity 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.
- Trial web siteNA
- statusplanned
- Sponsor/Initiator NutriLeads
- Funding
(Source(s) of Monetary or Material Support)
Fund = Initiator = Sponsor
- Publicationsnone
- Brief summaryGlobally, 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.
- Main changes (audit trail)
- RECORD25-jun-2018 - 9-jul-2018

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