Viewing Study NCT05222347



Ignite Creation Date: 2024-05-06 @ 5:12 PM
Last Modification Date: 2024-10-26 @ 2:23 PM
Study NCT ID: NCT05222347
Status: COMPLETED
Last Update Posted: 2022-02-03
First Post: 2022-02-01

Brief Title: Immunomodulatory and Preventive Effects of Olive Leaf Tea Against COVID-19
Sponsor: Bezmialem Vakif University
Organization: Bezmialem Vakif University

Study Overview

Official Title: Evaluation of the Immunomodulatory and Preventive Effects of Olive Leaf Tea Against COVID-19
Status: COMPLETED
Status Verified Date: 2022-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: During the Coronavirus Disease-2019 COVID-19 pandemic in addition to the current measures boosting the immune system seems to be one of preventive measures that can be taken against COVID-19 infection Various natural agents have been recommended to boost the immune system The aim of this study was to investigate the possible immunomodulatory and preventive effects of Olive Leaf Tea OLT drinking with regards to COVID-19 infection The study was conducted among 249 workers in a tractor factory where OLT was served Of the 249 workers 168 of them were OLT drinkers and 81 were not OLT drinkers Drinking at least one cup of OLT per day for a minimum of one month was the inclusion criteria used in the study The workers with a history of infection or vaccination of COVID-19 were excluded Lymphocyte subsets IL2 INF-gamma specific IgM and IgG levels were analyzed in all the study subjects The results showed higher values of CD3-CD1656 NK cells CD3CD1656 NKT cells total NK NKNKT cells and serum IFN-gamma and IL-2 levels in OLT drinkers as compared to the nondrinkers These immune changes are indicative of immune defense mechanisms Although all the OLT drinkers and non-drinkers reported no history of COVID-19 specific COVID-19 IgG levels were found positive in 60 of OLT drinkers and 38 OLT non-drinkers There were significant negative correlations between age and NK cells number of cigarettes smoked and NK cells number of cigarettes smoked and TNK and there were positive correlations between OLT drinking frequency and TNF-alpha IL-2 and IFN-gamma Also serum creatinine levels in OLT non-drinkers were found significantly higher than in the OLT drinkers In conclusion drinking OLT may contribute fighting against COVID-19 by boosting the innate immune system
Detailed Description: Coronavirus Disease-2019 COVID-19 is caused by severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 It emerged out of China in late 2019 and rapidly led to a pandemic in early 2020 As the mutations of the virus continue to increase the pandemic has become difficult to control and no specific treatment has been proven to be effective

According to the European Centre for Disease Prevention and Control ECDC until a safe and effective vaccine is available non-pharmaceutical tools are accepted as the most effective public health interventions against COVID-19 World Health Organization WHO states that in addition to public health and social measures it is also beneficial for individuals to maintain a balanced diet stay well hydrated exercise regularly and sleep well

It is now clear that there is a close interaction between the COVID-19 and the immune system of an individual resulting in diverse clinical manifestations of the disease While some patients present severe complications some individuals remain asymptomatic Weakened immunity is responsible for most COVID-19 deaths therefore elderly people with chronic diseases are considered at high risk from COVID-19

As soon as SARS-CoV-2 binds to angiotensin converting enzyme 2 ACE2 receptors and releases viral RNA for replication both the innate and adaptive immune responses are triggered Natural killer NK cells are innate effector lymphocytes that play a critical role in the first line of defense against tumor cells and viral infections They are essential in the early immune response against viral infections mainly through the clearance of virus-infected cells Human NK cells CD3-CD56 NK represent an average of 15 of peripheral blood and they can be subdivided based on the relative expression of the surface markers CD16 and CD56 Additionally in chronic viral infections CD56-CD16 NK cells are expanded and seems to represent an exhaustedanergic subset of NK cells Through several mechanisms NK cells provide exocytosis of perforin and granzyme causing lysis of the infected cell Fas ligand-mediated induction of apoptosis and antibody-dependent cellular cytotoxicity ADCC while having an essential role as immunomodulatory cells that bridge the innate and adaptive immune responses Natural killer T cells NKT are cells that express a semi-invariant T cell receptor TCR Crucial cytokines for the cytotoxic activity of NK and NKT cells are IL-2 and INF-gamma and these cytokines enhance the killing properties and proliferation of these cells Both IL-2 and IFN-gamma secretions are induced in a healthy young individual while this effect decreases in the elderly

Immune system boosting nutrition may play a role to lower the risk of infections by inhibiting virus replication promoting virus clearance inducing tissue repair and triggering a prolonged adaptive immune response against viruses Besides certain medicinal plants are known for their antiviral bioactivities and immune boosting capacity Some herbs have immunomodulatory potential and can be applied as a preventive medicine to combat COVID-19 Olive-leaf tea OLT is widely used in the traditional medicine in the Mediterranean region Due to the high concentration of phenolic compounds of which most abundant is oleuropein interest in olive leaf has increased recently The components of the olive leaves are known for their immune-modulatory anti-inflammatory antioxidant hypoglycemic antihypertensive antimicrobial and anti-atherosclerotic effects Although its antiviral mechanism of action is not fully known many studies have been conducted on the antiviral effects of olive leaf extract However studies on the protective or immune system strengthening effect of olive leaf extract against viral diseases are limited There is only one available in vitro study that shows olive leaf extract alters the immune response by increasing the number of CD8 and NK cells and IFN-gamma The aim of this study is to investigate the possible immunomodulatory and preventive effects of OLT against COVID-19

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None