Clinical trial NCT05598749: Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infection (URTI)
Lead sponsor: Fytexia
Sponsor class: INDUSTRY
First posted: 2022-10-28
Enrollment: 309
Sex: ALL
Minimum age (years): 25
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Supplementation Efficacy on URTI incidence
timeFrame: 12 weeks
measure: Supplementation Efficacy on number of URTI incidence
timeFrame: 12 weeks
Secondary outcomes:
measure: Supplementation Efficacy on URTI symptoms
timeFrame: 12 weeks
measure: Supplementation Efficacy on impact of URTI on quality of life
timeFrame: 12 weeks
measure: Supplementation Efficacy on URTI severity
timeFrame: 12 weeks
measure: Supplementation Efficacy on immunomodulation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM (Universidad Catolica San Antonio de Murcia)
Study officials:
affiliation: UCAM (Universidad Catolica San Antonio de Murcia)
name: Pedro Alcaraz
role: PRINCIPAL_INVESTIGATOR
References: