Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT06677658
Status:
COMPLETED
Last Update Posted:
2024-11-07
First Post:
2024-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Olive Oil in the Treatment of Covid-19 Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2024-11-02', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive effect of olive oil on clinical and laboratory parameters in patients given pulse steroid therapy due to Covid 19 pneumonia.', 'timeFrame': 'After 3 days of 250 mg/day pulse steroid ( methylprednisolone ) treatment and during hospital stay.', 'description': '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.\n\nPositive 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.'}], 'secondaryOutcomes': [{'measure': 'Intensive care requirement and mortality in patients diagnosed with covid-19 pneumonia taking olive oil.', 'timeFrame': 'After 3 days of 250 mg/day pulse steroid treatment and during hospital stay', 'description': 'Among patients diagnosed with Covid-19 pneumonia and given pulse steroid treatment, those who routinely used olive oil in their daily diets required less intensive care and had lower mortality.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Pneumonia', 'Olive Oil', 'Steroid', 'Immune system'], 'conditions': ['COVID-19 Pneumonia', 'Nutrition, Healthy']}, 'referencesModule': {'references': [{'pmid': '38287752', 'type': 'BACKGROUND', 'citation': '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': '32872374', 'type': 'BACKGROUND', 'citation': 'Alkhatib A. Antiviral Functional Foods and Exercise Lifestyle Prevention of Coronavirus. Nutrients. 2020 Aug 28;12(9):2633. doi: 10.3390/nu12092633.'}, {'pmid': '35807545', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nMethod: 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.', 'detailedDescription': 'Introduction: In the COVID-19 pandemic, many patients with lung involvement who received pulse steroid treatment showed improvement in clinical, laboratory, radiological, and survival parameters. It was observed that a significant number of patients who showed improvement consumed natural olive oil, and while the follow-up and treatment of these patients continued, the effect of oral consumption of natural olive oil on clinical, laboratory parameters, and survival of the patients was the subject of research \\[1\\]. 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 \\[1, 2\\]. The Mediterranean diet, which includes extra virgin olive oil and a correct lifestyle, can prevent low-grade inflammation and other chronic pathologies by directly affecting the intestinal microbiota and the immune system. A study has stated that olive oil can be used pharmacotherapeutically against SARS-CoV 2 \\[3\\]. In this context, it has been predicted that the consumption of 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, we 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.\n\nMethod: This retrospective observational 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. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Ethics committee approval has been granted from our institution with protocol number 22.05.2024/03, and informed consent has been obtained from all participants.\n\nParticipants were examined in two groups according to their olive oil consumption status. Patients diagnosed with COVID-19 pneumonia treated with pulse steroids ( methylprednisolone 250 mg/day) for three days and routinely consumed at least 20 ml olive oil in their daily diets were defined as Group 1. 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.\n\nReferences:\n\n1. Soo CI, Poon KV, Ayub A, You HW, Tan CX, Loh KJJ, et al. 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. Medical Journal of Malaysia. 2024;79(1):15-20.\n2. Alkhatib A. Antiviral functional foods and exercise lifestyle prevention of coronavirus. Nutrients. 2020;12(9):2633. doi: 10.3390/nu12092633.\n3. Hendi AA, Virk P, Awad MA, Elobeid M, Ortashi KM, Alanazi MM, et al. 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;27(13):4301. doi: 10.3390/molecules27134301.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '27 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study included patients aged ≥18 who were diagnosed with COVID-19 and had lung involvement (COVID-19 pneumonia).\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT06677658', 'briefTitle': 'The Role of Olive Oil in the Treatment of Covid-19 Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Giresun University'}, 'officialTitle': 'Effects of Olive Oil on Clinical, Laboratory and Survival in Patients Given Pulse Steroid Treatment for Covid-19 Pneumonia', 'orgStudyIdInfo': {'id': '22.05.2024-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': '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.', 'interventionNames': ['Dietary Supplement: Olive Oil', 'Drug: Methylprednisolone']}, {'label': 'Group 2', 'description': '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.', 'interventionNames': ['Drug: Methylprednisolone']}], 'interventions': [{'name': 'Olive Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Group 1']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Pulse steroid'], 'description': 'Both groups were diagnosed with Covid-19 pneumonia and were given pulse steroid ( methylprednisolone ) treatment at 250 mg/day for 3 days.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28100', 'city': 'Giresun', 'state': 'Giresun', 'country': 'Turkey (Türkiye)', 'facility': 'Giresun Training and Research Hospital', 'geoPoint': {'lat': 40.91698, 'lon': 38.38741}}], 'overallOfficials': [{'name': 'Selda Günaydın, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant researcher'}, {'name': 'Ersin Kuloğlu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant researcher'}, {'name': 'Gökhan Aydın, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant researcher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Giresun University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}