Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

Fytexia

Status

Completed

Conditions

Upper Respiratory Tract Infection (URTI)

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Verum

Study type

Interventional

Funder types

Industry

Identifiers

NCT05598749

ESIT12IES

Details and patient eligibility

About

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.

Enrollment

309 patients

Sex

All

Ages

25 to 69 years old

Volunteers

Accepts Healthy Volunteers

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)