COVID-19 PneumoniaNCT06677658
The Role of Olive Oil in the Treatment of Covid-19 Pneumonia
An observational study of COVID-19 Pneumonia and Nutrition, Healthy, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 27 to 95 years
- Conditions the study is for
- COVID-19 Pneumonia, Nutrition, Healthy
- What is being tested?
- Olive Oil and Methylprednisolone
- Type of treatment
- Pill or oral medicine
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 7 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- The study included patients aged ≥18 who were diagnosed with COVID-19 and had lung involvement (COVID-19 pneumonia).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Training and Research Hospital
Giresun, Giresun, 28100
About this study
Official title: Effects of Olive Oil on Clinical, Laboratory And Survival In Patients Given Pulse Steroid Treatment For Covid-19 Pneumonia
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.
Read the detailed description
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.
Method: 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.
Participants 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.
References:
- 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.
- Alkhatib A. Antiviral functional foods and exercise lifestyle prevention of coronavirus. Nutrients. 2020;12(9):2633. doi: 10.3390/nu12092633.
- 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.
- Conditions
- COVID-19 Pneumonia, Nutrition, Healthy
- Being tested
- Olive Oil, Methylprednisolone
- Keywords
- COVID-19, Pneumonia, Olive Oil, Steroid, Immune system
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Also called Pulse steroid
Both groups were diagnosed with Covid-19 pneumonia and were given pulse steroid ( methylprednisolone ) treatment at 250 mg/day for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Olive Oil; Drug: 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. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: After 3 days of 250 mg/day pulse steroid treatment and during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Selda Günaydın, MD, Study chair, Assistant researcherErsin Kuloğlu, MD, Study chair, Assistant researcherGökhan Aydın, MD, Study chair, Assistant researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677658
- Sponsor's protocol ID
- 22.05.2024-03
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38287752Alkhatib A. Antiviral Functional Foods and Exercise Lifestyle Prevention of Coronavirus. Nutrients. 2020 Aug 28;12(9):2633. doi: 10.3390/nu12092633.
PubMed 32872374Hendi 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.
PubMed 35807545
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Olive Oil on Clinical, Laboratory And Survival In Patients Given Pulse Steroid Treatment For Covid-19 Pneumonia
- ClinicalTrials.gov ID
- NCT06677658
- Acronym / sponsor ID
- 22.05.2024-03
- Conditions
- COVID-19 Pneumonia, Nutrition, Healthy
- Keywords
- COVID-19, Pneumonia, Olive Oil, Steroid, Immune system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Method: 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.
Participants 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.
References:
- 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.
- Alkhatib A. Antiviral functional foods and exercise lifestyle prevention of coronavirus. Nutrients. 2020;12(9):2633. doi: 10.3390/nu12092633.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Dietary Supplement: Olive Oil, Drug: MethylprednisolonePatients 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. |
| Group 2 | – | Drug: MethylprednisolonePatients 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. |
Who may qualify
- Ages
- 27 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- The study included patients aged ≥18 who were diagnosed with COVID-19 and had lung involvement (COVID-19 pneumonia).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive OilGroup 1 included patients who consumed at least 20 ml of oral olive oil daily. Group 2 included patients who did not consume olive oil. | Dietary supplement | Group 1 |
| MethylprednisoloneAlso: Pulse steroidBoth groups were diagnosed with Covid-19 pneumonia and were given pulse steroid ( methylprednisolone ) treatment at 250 mg/day for 3 days. | Drug | Group 1, Group 2 |
Primary outcome
Positive effect of olive oil on clinical and laboratory parameters in patients given pulse steroid therapy due to Covid 19 pneumonia.
Time frame: After 3 days of 250 mg/day pulse steroid ( methylprednisolone ) treatment and during hospital stay.
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.
1 secondary outcome
Intensive care requirement and mortality in patients diagnosed with covid-19 pneumonia taking olive oil.
Time frame: After 3 days of 250 mg/day pulse steroid treatment and during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Results publication: PubMed 38287752Soo 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.
- Results publication: PubMed 32872374Alkhatib A. Antiviral Functional Foods and Exercise Lifestyle Prevention of Coronavirus. Nutrients. 2020 Aug 28;12(9):2633. doi: 10.3390/nu12092633.
- Results publication: PubMed 35807545Hendi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Günaydın, MD study chair
Assistant researcher
Ersin Kuloğlu, MD study chair
Assistant researcher
Gökhan Aydın, MD study chair
Assistant researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Nutrition, Healthy, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive effect of olive oil on clinical and laboratory parameters in patients given pulse steroid therapy due to Covid 19 pneumonia. (time frame: After 3 days of 250 mg/day pulse steroid ( methylprednisolone ) treatment and during hospital stay.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06677658, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.