Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

Evaluation of the Immunomodulation Effect of ESIT12, a Poplar-type Propolis Dry Extract and Its Efficacy in Subjects At Risk of Contracting Upper Respiratory Tract Infections (URTIs)

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.

Inclusion Criteria:

• inactive or minimally active according to the IPAQ short form questionnaire
• BMI 18,5-29,9

Exclusion Criteria:

• 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)