NCT06677658

Brief Summary

Objective: Consuming natural olive oil in patients diagnosed with COVID-19 Pneumonia may strengthen immunity, slow down disease progression, and lower mortality. Within the scope of this research, the investigators aimed to elucidate the effect of using natural olive oil on clinical, laboratory, and radiological findings and survival in patients diagnosed with COVID-19 pneumonia and given pulse steroid treatment. Method: This retrospective observational research enrolled 130 patients diagnosed with COVID-19 pneumonia. Participants were examined in two groups according to their olive oil consumption status. Patients diagnosed with COVID-19 pneumonia treated with pulse steroids for three days who routinely consumed oral olive oil in their daily diets were defined as Group 1, and those who did not consume olive oil were defined as Group 2.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 2, 2024

Last Update Submit

November 5, 2024

Conditions

Keywords

COVID-19PneumoniaOlive OilSteroidImmune system

Outcome Measures

Primary Outcomes (1)

  • Positive effect of olive oil on clinical and laboratory parameters in patients given pulse steroid therapy due to Covid 19 pneumonia.

    The benefits of olive oil consumption can be increased through physical activity, especially strength and resistance exercise. Such an approach is likely to prevent viral infections effectively. In terms of the recommended dose of olive oil, a moderate dose of 20-30 grams/day (especially extra virgin olive oil rich in polyphenols) can be recommended in combination with other dietary functional foods to strengthen the immune system, which is in line with the latest non-communicable disease prevention recommendations. Positive effects of regular daily olive oil use on clinical and laboratory parameters were observed in patients receiving pulse steroid treatment due to Covid-19 pneumonia.

    After 3 days of 250 mg/day pulse steroid ( methylprednisolone ) treatment and during hospital stay.

Secondary Outcomes (1)

  • Intensive care requirement and mortality in patients diagnosed with covid-19 pneumonia taking olive oil.

    After 3 days of 250 mg/day pulse steroid treatment and during hospital stay

Study Arms (2)

Group 1

Patients diagnosed with COVID-19 pneumonia treated with pulse steroids (250 mg/day) for three days and routinely consumed at least 20 ml/day olive oil in their diets were defined as Group 1.

Dietary Supplement: Olive OilDrug: Methylprednisolone

Group 2

Patients of similar age and gender with COVID-19 pneumonia who received the same treatment but did not consume olive oil were defined as Group 2.

Drug: Methylprednisolone

Interventions

Olive OilDIETARY_SUPPLEMENT

Group 1 included patients who consumed at least 20 ml of oral olive oil daily. Group 2 included patients who did not consume olive oil.

Group 1

Both groups were diagnosed with Covid-19 pneumonia and were given pulse steroid ( methylprednisolone ) treatment at 250 mg/day for 3 days.

Also known as: Pulse steroid
Group 1Group 2

Eligibility Criteria

Age27 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This research enrolled 130 patients diagnosed with COVID-19 pneumonia, confirmed with real-time polymerase chain reaction (RT-PCR). The patients were segmented into two groups (n=65 in each) according to their olive oil consumption. However, all of the patients included in the study were patients diagnosed with covid-19 pneumonia and given pulse steroid treatment.

You may qualify if:

  • The study included patients aged ≥18 who were diagnosed with COVID-19 and had lung involvement (COVID-19 pneumonia).

You may not qualify if:

  • Patients under the age of 18, pregnant women, individuals intubated due to severe respiratory failure in COVID-19 pneumonia, and those who received alternative treatments other than pulse steroid treatment (Immunoplasma, Tocilizumab, Anakinra, Plasmapheresis, Stem Cell Therapy, etc.) were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun Training and Research Hospital

Giresun, Giresun, 28100, Turkey (Türkiye)

Location

Related Publications (3)

  • Soo CI, Poon KV, Ayub A, You HW, Tan CX, Loh KJJ, Eng CCH, Sia LC, Wong CK. High-dose pulse methylprednisolone vs. dexamethasone standard therapy for severe and critical COVID-19 pneumonia: Efficacy assessment in a retrospective single-centre experience from Malaysia. Med J Malaysia. 2024 Jan;79(1):15-20.

    PMID: 38287752BACKGROUND
  • Alkhatib A. Antiviral Functional Foods and Exercise Lifestyle Prevention of Coronavirus. Nutrients. 2020 Aug 28;12(9):2633. doi: 10.3390/nu12092633.

    PMID: 32872374BACKGROUND
  • Hendi AA, Virk P, Awad MA, Elobeid M, Ortashi KMO, Alanazi MM, Alkallas FH, Almoneef MM, Abdou MA. In Silico Studies on Zinc Oxide Based Nanostructured Oil Carriers with Seed Extracts of Nigella sativa and Pimpinella anisum as Potential Inhibitors of 3CL Protease of SARS-CoV-2. Molecules. 2022 Jul 4;27(13):4301. doi: 10.3390/molecules27134301.

    PMID: 35807545BACKGROUND

MeSH Terms

Conditions

COVID-19Pneumonia

Interventions

Olive OilMethylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Selda Günaydın, MD

    Assistant researcher

    STUDY CHAIR
  • Ersin Kuloğlu, MD

    Assistant researcher

    STUDY CHAIR
  • Gökhan Aydın, MD

    Assistant researcher

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2024

First Posted

November 7, 2024

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

September 7, 2022

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations