Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study
- Conditions
- Upper Respiratory Tract Infection (URTI)
- Registration Number
- NCT05598749
- Lead Sponsor
- Fytexia
- Brief Summary
The aim of the present investigation is to evaluate the immunomodulation effect of ESIT12, a poplar-type propolis dry extract standardized in polyphenols, and its efficacy in subjects at risk of contracting upper respiratory tract infections (URTIs), during a 12-week supplementation period plus 4-week follow-up.
The number of onset of upper respiratory tract infections, the symptoms severity and lasting and interferences with well-being will be assessed with WURSS-24 questionnaire. The quality of life will be assessed with the SF-36 questionnaire and a testimonial. Blood immune markers will also be assessed. Finally, long lasting benefits will additionally be evaluated 4 weeks after end of the supplementation period. The design of the study is double-blind, randomized, parallel and placebo controlled.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- inactive or minimally active according to the IPAQ short form questionnaire
- BMI 18,5-29,9
- Pregnant women, breastfeeding women, women positive at Beta-HCG serology test and who hope to become pregnant
- Allergy to beehive products and known allergy (general)
- Cystic fibrosis
- Congenital or acquired immunodeficiency syndrome and disease
- History of asthma (within prior 24 months) or chronic respiratory disease
- Subjects who underwent medical treatment for COVID-19 within last 3 months
- History of immune system disorder or auto-immune disorder
- History of treated diabetes or treated hypertension
- Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, and malignancies
- Cancers
- Those considered unsuitable for the participation by the physician
- No vaccination within 12 weeks prior to enrolling in the study
- No antibiotics within 12 weeks prior to enrolling in the study
- No anti-inflammatory drugs within 4 weeks prior to enrolling in the study
- No steroids within 12 weeks prior to enrolling in the study
- No immunological drugs within 4 weeks prior to enrolling in the study
- No food/dietary supplements within 4 weeks prior to enrolling in the study
- No current or recent participation in another clinical trial (within 30 days prior to screening)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Supplementation Efficacy on URTI incidence 12 weeks The incidence of URTI developped in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire
Supplementation Efficacy on number of URTI incidence 12 weeks The number of URTI incidence per person in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire
- Secondary Outcome Measures
Name Time Method Supplementation Efficacy on URTI symptoms 12 weeks The comparison of symptoms score (domain 2) between placebo and verum as measured with WURSS-24 questionnaire
Supplementation Efficacy on URTI severity 12 weeks The comparison of global cold severity (domain 4) between placebo and verum as measured with WURSS-24 questionnaire
Supplementation Efficacy on immunomodulation 12 weeks Assessment of immunological vigor (SIV) as monitored by 4 PBMC panels Panel 1 : global activation Panel 2 : Tcells focus Panel 3 : B cells focus Panel : Neutrophils / monocytes focus
Supplementation Efficacy on impact of URTI on quality of life 12 weeks The comparison of cold-specific functional impairments (domain 3) between placebo and verum as measured with WURSS-24 questionnaire
Trial Locations
- Locations (1)
UCAM (Universidad Catolica San Antonio de Murcia)
🇪🇸Murcia, Spain
UCAM (Universidad Catolica San Antonio de Murcia)🇪🇸Murcia, Spain