Nutritional Habits, and Coronavirus Disease 2019 (COVID-19) Outcome

NCT ID: NCT04447144

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

As of May 30th more than 23,000 cases of COVID -19 cases were confirmed in Egypt with total deaths of 913. Post viral entry, intense immune response against the virus with infiltration of monocytes and macrophages into alveolar cells with decreasing number of lymphocytes in peripheral blood along with reduced lymphocytes in lymphoid organs, hypercoagulability, thrombosis and multiple organ damage, The gut microbiota and immune homeostasis seem to have a back and forth relationship.

Also, gut microbiota derived signals are known to tune the immune cells for pro and anti-inflammatory responses thereby affecting the susceptibility to various diseases. Healthy gut microbiome essentially could be pivotal in maintaining an optimal immune system to prevent an array of excessive immune reactions that eventually become detrimental to lungs and vital organ systems.

Numerous studies have shown that the patient's nutritional status have a significant effect on an individual's immunity and over all health status and it has been suggested that nutritional deficiencies may predispose to severe forms of COVID-19 infections.

Co-existing non-communicable chronic diseases (NCDs) in COVID-19 patients have been found to delay patients recovery and worsen their prognosis, the reason may be due to aggravated inflammatory pathology found in NCDs exacerbating COVID-19 infection.

The aim of the study is to evaluate the role dietary habits among COVID-19 Egyptian patients and whether type of diet (Mediterranean or Western) will affect disease outcomes

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

As of May 30th more than 23,000 cases of COVID -19 cases were confirmed in Egypt with total deaths of 913. There are over six million confirmed cases of COVID-19 and almost 370,000 deaths globally. COVID-19 originated from Wuhan city, China in early 2020, from their extending to the rest of the world. The virus belong to a large class of viruses known as β-coronaviruses with a large number of potential natural primary, intermediate and final hosts. Severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is an enveloped RNA virus that typically spread by droplets causing pulmonary and extra-pulmonary complications.

COVID-19 can result in cytokine storm, which in severe cases can lead to acute respiratory distress syndrome (ARDS), sepsis and multiple organ dysfunction that can progress to death. Post SARS-CoV-2 entry, intense immune response against the virus with infiltration of monocytes and macrophages into alveolar cells with decreasing number of lymphocytes in peripheral blood along with reduced lymphocytes in lymphoid organs, hypercoagulability, thrombosis and multiple organ damage. This along with the fact that some patients of this disease have diarrhea points out towards a distinct possibility of involvement of gut-lung axis and may be the gut microbiota.

The gut microbiota and immune homeostasis seem to have a back and forth relationship. Also, gut microbiota derived signals are known to tune the immune cells for pro and anti-inflammatory responses thereby affecting the susceptibility to various diseases.

Many elderly and immune-compromised patients progress to serious adverse clinical outcomes, it is therefore tempting to speculate that in COVID-19, there is a possible cross-talk taking place between the lung and the gut microbiota which might influence the outcome of the clinical manifestation.

Healthy gut microbiome essentially could be pivotal in maintaining an optimal immune system to prevent an array of excessive immune reactions that eventually become detrimental to lungs and vital organ systems.

Several studies have shown that increased D-dimer levels are associated with severe forms of COVID-19 infection, this might be explained by diffuse alveolar damage, pneumocytes desquamation, pulmonary edema, interstitial mononuclear cells and lymphocytes infiltration causing intense inflammatory burden induced in severe COVID-19 infections.

Numerous studies have shown that the patient's nutritional status have a significant effect on an individual's immunity and over all health status and it has been suggested that nutritional deficiencies may predispose to severe forms of COVID-19 infections. Adequate Fruits and vegetables consumption have been studied for their potential protective effects against respiratory diseases and anti-inflammatory effects, furthermore, fruits and vegetables are also rich sources of fibers that have favorable effects on gut microbiome. One of very familiar water-soluble vitamins; Vitamin C (ascorbic acid) , that can be found in citrus fruits, barriers, leafy greens, tomatoes, and various other fruits and vegetables. Indeed, 1-2 g supplementation of vitamin C was found to shorten the duration of common cold by 18%, according to the United states National Institute of health (NIH) the recommended daily allowances (RDA) of vitamin C for healthy adults is 75-90 mg/d.

The Sunshine vitamin (Vitamin D) which is found in mushrooms, eggs, salmon and milk was found in a meta-analysis of 25 randomized controlled trails conducted over more than 11,000 participants, an overall protective effect of vitamin D supplementation in acute respiratory infections and, also, COVID-19, studies also suggested to possible role of Vitamin D as an antiviral immunomodulator through anti-inflammatory properties, for this reason, Vitamin D have been suggested to have a beneficial effects against SARS-CoV-2 infection (16), another study done in Switzerland on SARS-CoV-2 positive patients found to have significant lower levels (mean value 11.1 ng/mL) of 25-hydroxyvitamin D. The recommended RDA of vitamin D according to NIH 15-20 ug/d (600-800 IU with tolerable upper limit of 4000 IU). Another vitamin with anti-inflammatory benefits, fat soluble vitamin E (œ-tocopherol) found in seeds, green leafy vegetables, nuts, and fortified cereals. Vitamin E has been labeled as immunoenhancing vitamin by with anti-inflammatory properties by regulating the production of Reactive Oxygen Species (ROS) and Reactive Nitrogen Species (RNS) and modulating signal transduction, thus protecting The polyunsaturated fatty acids (PUFAs) in the cell membranes, for this reason, it has been suggested that the combination of Vitamins C, D \& E may be useful in COVID-19 patients. The RDA of Vitamin E for healthy adults according to the NIH is 15 mg/d (tolerable upper level 1000 mg/d).

Regarding minerals, Zinc has been found to have a critical role in maintaining immune cells integrity and important cofactor for numerous enzyme, zinc deficiency can cause impaired cell-mediated immunity predisposing to various infections, especially respiratory infections, available food sources of zinc including; meats, legumes and diary products, the RDA of zinc according to NIH is 8-11 mg/d (with 40 mg/day tolerable upper intake level).

Another essential trace element is Copper that can be found in nuts and offal and, in lesser concentrations in cereals and fruits, copper has a pivotal role in maintaining DNA integrity by its antioxidant effects, studies have shown that adequate copper supplementation can reduce lung inflammation in mice, according to NIH, the RDA of copper is 900 ug/d (tolerable upper limit of 10 mg/d).

Regular intake of prebiotic foods such as oligosaccharides, fermentable fibers, and resistant starches can beneficially affect the gut microbiota, prebiotic fibers are considered selective substrates for specific beneficial colonic bacteria as they are neither hydrolyzed nor absorbed in the proximal gut. Dietary fibers have been suggested as immunity modulators as they lower incidence of bacterial translocation by maintaining integrity of the gut barrier, available sources include; oat, barley, seeds, nuts, peas and some fruits, the recommended daily intake is 25-38 g/day. Probiotic foods (from dairy products as yogurt\& sour cream) and supplements have the ability to modify the gut microbiota and potentially modulate gut inflammatory response.

D-dimer is a fibrin degradation product (FDP) that reflects bath thrombin production and activation, elevated levels have been linked to increased risk of coronary artery disease, cerebrovascular strokes and total mortality, so far the link between dietary habits and D-dimer levels has been poorly explored. Studies have reported, that adherence to a Mediterranean diet was found to be associated with decreased levels of D-dimer, with possible antithrombotic effects due to high content of fibers, antioxidants, mono and polyunsaturated fatty acids.

Co-existing non-communicable chronic diseases (NCDs) in COVID-19 patients have been found to delay patients recovery and worsen their prognosis, the reason may be due to aggravated inflammatory pathology found in NCDs exacerbating COVID-19 infection. Such patients with underlying cardiovascular, respiratory disease were found to have worse prognosis, diabetes, hypertension and hypercholesterolemia are considered major risk factors for thrombotic complications, which in COVID-19 patients may account for higher risk of serious disease outcome and is associated with two-folds increase in mortality.

Fish and fish oils are considered very beneficial to individual health especially in patients with NCDs including cardiovascular diseases. Omega-3-polyunsaturated fatty acids (PUFA) are integral component of the cell membrane thus having anti-inflammatory effects, however, substantial human trials in this area are lacking.

For this reason, an effective approach to reduce person's risk of developing NCDs is to halt underlying inflammation via modifiable risk factors including; diet, exercise and healthy lifestyle choices. To date, there is no single food or natural remedy that has been used for preventing COVID-19 infections. Healthy diets containing adequate amounts of necessary macro and micronutrients, prebiotics and probiotics that can maintain and restore immune system, therefore increasing protection against chronic inflammation-related NCDs. Foods with anti-inflammatory and immunomodulatory compounds including essential vitamins (C, D \& E) and minerals (Zinc, Copper, Calcium \& Selenium) are considered protective foods, these micronutrients can act in harmony to prevent thrombotic and reactive oxygen species (ROS) complications by their anti-inflammatory properties. They are present in fair amounts in Mediterranean Diet, which is characterized by increased dietary consumption of legumes, olive oil, whole grains, nuts, and monounsaturated fats, minimally processed fruits, vegetables, associated with low to moderate consumption of fermented dairy products, fish, poultry. Antithrombotic advantages of Mediterranean diet have been explained by reduced levels of factor VII, tissue factor, platelets and leucocytes counts in individuals consuming Mediterranean diet. On the other hand, The "Western" dietary pattern, which is characterized by high consumption of saturated fats, refined carbohydrates, red meat, deserts and sweets, that may be associated with hyperglycemia, hyperlipidemia and chronic inflammatory state.

The aim of the study is to evaluate the role dietary habits among COVID-19 Egyptian patients and whether type of diet (Mediterranean or Western) will affect disease outcomes.

The current study also trying to determine if balanced diet maintaining healthy gut microbiota can have a role in avoiding disease progression and deterioration in COVID-19 cases.

Dietary pattern questionnaire for COVID 19 patient Name:- Age :- The work:- height :- Weight :- BMI :-

* Did you lose weight during the previous 3 months?
* Do you smoke?
* What is your usual breakfast before the injury and when to take it ?
* What is your usual lunch before the injury and when to take it ?
* What is your usual dinner before the injury and when to take it ?
* Did you eat between meals and what you eat?
* How many cups of water you drink daily?
* Do you eat salads or fresh vegetables daily (type and amount)?
* Do you eat fruit daily (type and amount )?
* Do you drink milk daily ?
* Do you eat yogurt daily?
* Do you drink fermented milk daily?
* Do you eat cheese daily(type and amount)?
* Do you eat fish weekly ( type and amount)?
* Do you eat pickles daily(amount) ?
* Are you exposed to the sun daily ( duration and time)?
* Number of spoons of sugar taken per day ( and sweets)?
* Types of drinks daily and their times ?
* Frequency of eating out ( weekly)?
* Do you eat any of these food daily ( cocoa , cashew , cheddar, chicken , meat, Milk , almond , salmon , yogurt)?
* Number of times eating eggs per week ?
* The type and amount of fats used in cooking :-
* Number of hours of sleep per day :-
* Antibiotic intake rate:-
* Have you take any supplements and vitamins for the past months?

The analysis of the above food habits questionnaire Will be fitted to a scoring system from 0 to 32 points covering the following

1. Probiotic in food
2. Prebiotic in food
3. Vitamins and minerals in food
4. Mediterranean type of food
5. Antibiotics intake that affect gut microbiota
6. Tea frequency and amount intake with respecting it's role on microbiota
7. Exercise daily and it's effect on immune system and lung capacity

All patients will be followed up for 14 days For disease recovery or progression to severe category.

Statistical analysis will be done after tabulation of the results to correlate with microbiome as well as the clinical status of patients.

Aim and Expected outcomes: The novelty of this study is that the investigators will get information about the role and type of diet on COVID-19 outcome and clarifying the role certain macro and micronutrients in inducing chronic inflammation, protecting from thrombosis The investigators also hope through this research to modify dietary habits in the Egyptian society encouraging healthy nutrition with the pre and probiotics food role to retain normal healthy life.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Chronic Inflammation Non-Communicable Chronic Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Covid19 noncommunicable diseases chronic inflammation Mediterranean diet

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COVID-19 mild severity

Definition of mild cases according to MOH:

1. Age \< 60
2. Temperature \<38.5
3. arterial oxygen saturation (SaO2) \>92%
4. Heart Rate \<110
5. Respiratory Rate \<25 /min.
6. Neutrophil / lymphocyte ratio on complete blood count (CBC) \< 3.1
7. No co-morbidities that necessitates hospital admission: Pregnancy, severe uncontrolled Diabetes, Chronic lung disease, Chronic kidney disease, Chronic liver disease, Serious heart diseases (arrythmia, Ischemic heart disease, uncontrolled hypertension), immunocompromised: prolonged use of corticosteroids and other immunosuppressive drugs/ organ transplantation/ HIV/ Immunodeficiency, Obesity (BMI \> 40)

No interventions assigned to this group

COVID-19 moderate severity

Any patient not fulfilling the above mild criteria is considered having moderate disease as well as any positive pulmonary imaging findings

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Patients (18 -80 years) with mild to moderate COVID-19 cases consented to home or hospital isolation to follow them.

Exclusion Criteria

Severe cases not fulfilling the definition of mild and moderate cases.

Definition of mild cases according to The Egyptian Ministry Of Health: (MOH)

1. Age \< 60
2. Temperature \<38.5
3. SaO2 \>92%
4. Heart Rate \<110
5. Respiratory Rate \<25 /min.
6. Neutrophil / lymphocyte ratio on CBC \< 3.1
7. No co-morbidities that necessitates hospital admission: Pregnancy, severe uncontrolled Diabetes, Chronic lung disease, Chronic kidney disease, Chronic liver disease, Serious heart diseases (arrythmia, Ischemic heart disease, uncontrolled hypertension), immunocompromised: prolonged use of corticosteroids and other immunosuppressive drugs/ organ transplantation/ HIV/ Immunodeficiency, Obesity (BMI \> 40) Any patient not fulfilling the above mild criteria is considered having moderate disease as well as any positive pulmonary imaging findings
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mona Hegazy

Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed M Abdul Ghani, MD

Role: STUDY_DIRECTOR

Lecture of Internal Medicine Hepatology & gastroenterology Unit

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mona M Abd-Elmonem Hegazy, MD

Role: CONTACT

Phone: +20 100 142 1551

Email: [email protected]

Ahmed M Abdul Ghani, MD

Role: CONTACT

Phone: +201005150375

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mona A Hegazy, MD

Role: primary

Ahmed M Abdul Ghani, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

John Hopkins University. John Hopkins University & Medicine: Coronavirus Resource Center. Available online: https://coronavirus.jhu.edu/map.html

Reference Type BACKGROUND

Wang L, Wang Y, Ye D, Liu Q. Erratum to ;;A review of the 2019 Novel Coronavirus (COVID-19) based on current evidence'' [International Journal of Antimicrobial Agents 55/6 (2020) 105948]. Int J Antimicrob Agents. 2020 Sep;56(3):106137. doi: 10.1016/j.ijantimicag.2020.106137. Epub 2020 Aug 18. No abstract available.

Reference Type BACKGROUND
PMID: 32826129 (View on PubMed)

Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

Reference Type BACKGROUND
PMID: 32171076 (View on PubMed)

Zhang W, Zhao Y, Zhang F, Wang Q, Li T, Liu Z, Wang J, Qin Y, Zhang X, Yan X, Zeng X, Zhang S. The use of anti-inflammatory drugs in the treatment of people with severe coronavirus disease 2019 (COVID-19): The Perspectives of clinical immunologists from China. Clin Immunol. 2020 May;214:108393. doi: 10.1016/j.clim.2020.108393. Epub 2020 Mar 25.

Reference Type BACKGROUND
PMID: 32222466 (View on PubMed)

Chin VK, Yong VC, Chong PP, Amin Nordin S, Basir R, Abdullah M. Mycobiome in the Gut: A Multiperspective Review. Mediators Inflamm. 2020 Apr 4;2020:9560684. doi: 10.1155/2020/9560684. eCollection 2020.

Reference Type BACKGROUND
PMID: 32322167 (View on PubMed)

Negi S, Pahari S, Bashir H, Agrewala JN. Gut Microbiota Regulates Mincle Mediated Activation of Lung Dendritic Cells to Protect Against Mycobacterium tuberculosis. Front Immunol. 2019 May 28;10:1142. doi: 10.3389/fimmu.2019.01142. eCollection 2019.

Reference Type BACKGROUND
PMID: 31231363 (View on PubMed)

Nagpal R, Mainali R, Ahmadi S, Wang S, Singh R, Kavanagh K, Kitzman DW, Kushugulova A, Marotta F, Yadav H. Gut microbiome and aging: Physiological and mechanistic insights. Nutr Healthy Aging. 2018 Jun 15;4(4):267-285. doi: 10.3233/NHA-170030.

Reference Type BACKGROUND
PMID: 29951588 (View on PubMed)

Round JL, Mazmanian SK. Inducible Foxp3+ regulatory T-cell development by a commensal bacterium of the intestinal microbiota. Proc Natl Acad Sci U S A. 2010 Jul 6;107(27):12204-9. doi: 10.1073/pnas.0909122107. Epub 2010 Jun 21.

Reference Type BACKGROUND
PMID: 20566854 (View on PubMed)

Yao Y, Cao J, Wang Q, Shi Q, Liu K, Luo Z, Chen X, Chen S, Yu K, Huang Z, Hu B. D-dimer as a biomarker for disease severity and mortality in COVID-19 patients: a case control study. J Intensive Care. 2020 Jul 10;8:49. doi: 10.1186/s40560-020-00466-z. eCollection 2020.

Reference Type BACKGROUND
PMID: 32665858 (View on PubMed)

Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.

Reference Type BACKGROUND
PMID: 32052466 (View on PubMed)

Hemila H, Chalker E. Vitamin C for preventing and treating the common cold. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD000980. doi: 10.1002/14651858.CD000980.pub4.

Reference Type BACKGROUND
PMID: 23440782 (View on PubMed)

Krinsky,N.I.; Beecher,G. ; Burk,R.; Chan,A.; Erdman,j.J.; Jacob,R.; Jialal,I.; Kolonel,L.; Marshall,J.;Taylor Mayne, P.R. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids; A Report of the Panel on Dietary Antioxidants and Related Compounds, Subcommittees on Upper Reference Levels of Nutrients and Interpretation and Uses of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Institute of Medicine; The National Academies Press: Washington, DC, USA, 2000.

Reference Type BACKGROUND

Martineau AR, Jolliffe DA, Hooper RL, Greenberg L, Aloia JF, Bergman P, Dubnov-Raz G, Esposito S, Ganmaa D, Ginde AA, Goodall EC, Grant CC, Griffiths CJ, Janssens W, Laaksi I, Manaseki-Holland S, Mauger D, Murdoch DR, Neale R, Rees JR, Simpson S Jr, Stelmach I, Kumar GT, Urashima M, Camargo CA Jr. Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data. BMJ. 2017 Feb 15;356:i6583. doi: 10.1136/bmj.i6583.

Reference Type BACKGROUND
PMID: 28202713 (View on PubMed)

Grant WB, Lahore H, McDonnell SL, Baggerly CA, French CB, Aliano JL, Bhattoa HP. Evidence that Vitamin D Supplementation Could Reduce Risk of Influenza and COVID-19 Infections and Deaths. Nutrients. 2020 Apr 2;12(4):988. doi: 10.3390/nu12040988.

Reference Type BACKGROUND
PMID: 32252338 (View on PubMed)

Teymoori-Rad M, Shokri F, Salimi V, Marashi SM. The interplay between vitamin D and viral infections. Rev Med Virol. 2019 Mar;29(2):e2032. doi: 10.1002/rmv.2032. Epub 2019 Jan 6.

Reference Type BACKGROUND
PMID: 30614127 (View on PubMed)

Jakovac H. COVID-19 and vitamin D-Is there a link and an opportunity for intervention? Am J Physiol Endocrinol Metab. 2020 May 1;318(5):E589. doi: 10.1152/ajpendo.00138.2020. No abstract available.

Reference Type BACKGROUND
PMID: 32297519 (View on PubMed)

D'Avolio A, Avataneo V, Manca A, Cusato J, De Nicolo A, Lucchini R, Keller F, Cantu M. 25-Hydroxyvitamin D Concentrations Are Lower in Patients with Positive PCR for SARS-CoV-2. Nutrients. 2020 May 9;12(5):1359. doi: 10.3390/nu12051359.

Reference Type BACKGROUND
PMID: 32397511 (View on PubMed)

Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium; Ross AC, Taylor CL, Yaktine AL, Del Valle HB, editors. Dietary Reference Intakes for Calcium and Vitamin D. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK56070/

Reference Type BACKGROUND
PMID: 21796828 (View on PubMed)

19. Wu,D.; Meydani, S.N. Vitamin E ,immunity, and infection. In Nutrition, Immunity, and Infection; CRC Press: Boca Raton, FL, USA, 2017; pp. 197-212.

Reference Type BACKGROUND

Coquette A, Vray B, Vanderpas J. Role of vitamin E in the protection of the resident macrophage membrane against oxidative damage. Arch Int Physiol Biochim. 1986 Dec;94(5):S29-34.

Reference Type BACKGROUND
PMID: 2440399 (View on PubMed)

Wang JZ, Zhang RY, Bai J. An anti-oxidative therapy for ameliorating cardiac injuries of critically ill COVID-19-infected patients. Int J Cardiol. 2020 Aug 1;312:137-138. doi: 10.1016/j.ijcard.2020.04.009. Epub 2020 Apr 6. No abstract available.

Reference Type BACKGROUND
PMID: 32321655 (View on PubMed)

Prasad AS. Zinc in human health: effect of zinc on immune cells. Mol Med. 2008 May-Jun;14(5-6):353-7. doi: 10.2119/2008-00033.Prasad.

Reference Type BACKGROUND
PMID: 18385818 (View on PubMed)

Hess SY, Lonnerdal B, Hotz C, Rivera JA, Brown KH. Recent advances in knowledge of zinc nutrition and human health. Food Nutr Bull. 2009 Mar;30(1 Suppl):S5-11. doi: 10.1177/15648265090301S102.

Reference Type BACKGROUND
PMID: 19472599 (View on PubMed)

Lordan R, Tsoupras A, Mitra B, Zabetakis I. Dairy Fats and Cardiovascular Disease: Do We Really Need to be Concerned? Foods. 2018 Mar 1;7(3):29. doi: 10.3390/foods7030029.

Reference Type BACKGROUND
PMID: 29494487 (View on PubMed)

Bost M, Houdart S, Oberli M, Kalonji E, Huneau JF, Margaritis I. Dietary copper and human health: Current evidence and unresolved issues. J Trace Elem Med Biol. 2016 May;35:107-15. doi: 10.1016/j.jtemb.2016.02.006. Epub 2016 Mar 5.

Reference Type BACKGROUND
PMID: 27049134 (View on PubMed)

Uriu-Adams JY, Keen CL. Copper, oxidative stress, and human health. Mol Aspects Med. 2005 Aug-Oct;26(4-5):268-98. doi: 10.1016/j.mam.2005.07.015.

Reference Type BACKGROUND
PMID: 16112185 (View on PubMed)

Liu L, Geng X, McDermott J, Shen J, Corbin C, Xuan S, Kim J, Zuo L, Liu Z. Copper Deficiency in the Lungs of TNF-alpha Transgenic Mice. Front Physiol. 2016 Jun 14;7:234. doi: 10.3389/fphys.2016.00234. eCollection 2016.

Reference Type BACKGROUND
PMID: 27378943 (View on PubMed)

Arrieta,M.C.; Meddings,J.; Field,C.J. The immunomodulatory effects of dietary fiber and prebiotics in the gastrointestinal tract. In Non digestible Carbohydrates and Digestive Health; Paeschke, T.M., Aimutis, W.R., Eds.; Blackwell Publishing Ltd. and Institute of Food Technologists: Ames, IA, USA, 2011; pp. 37-77.

Reference Type BACKGROUND

Schley PD, Field CJ. The immune-enhancing effects of dietary fibres and prebiotics. Br J Nutr. 2002 May;87 Suppl 2:S221-30. doi: 10.1079/BJNBJN/2002541.

Reference Type BACKGROUND
PMID: 12088522 (View on PubMed)

King DE, Mainous AG 3rd, Lambourne CA. Trends in dietary fiber intake in the United States, 1999-2008. J Acad Nutr Diet. 2012 May;112(5):642-8. doi: 10.1016/j.jand.2012.01.019. Epub 2012 Apr 25.

Reference Type BACKGROUND
PMID: 22709768 (View on PubMed)

Hasan N, Yang H. Factors affecting the composition of the gut microbiota, and its modulation. PeerJ. 2019 Aug 16;7:e7502. doi: 10.7717/peerj.7502. eCollection 2019.

Reference Type BACKGROUND
PMID: 31440436 (View on PubMed)

Di Castelnuovo A, Bonaccio M, De Curtis A, Costanzo S, Persichillo M, de Gaetano G, Donati MB, Iacoviello L; MOLI-SANI investigators. Higher adherence to the Mediterranean diet is associated with lower levels of D-dimer: findings from the MOLI-SANI study. Haematologica. 2017 Feb;102(2):e61-e64. doi: 10.3324/haematol.2016.156331. Epub 2016 Oct 20. No abstract available.

Reference Type BACKGROUND
PMID: 27846616 (View on PubMed)

Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.

Reference Type BACKGROUND
PMID: 32139904 (View on PubMed)

Wadman M, Couzin-Frankel J, Kaiser J, Matacic C. A rampage through the body. Science. 2020 Apr 24;368(6489):356-360. doi: 10.1126/science.368.6489.356. No abstract available.

Reference Type BACKGROUND
PMID: 32327580 (View on PubMed)

Kumar A, Arora A, Sharma P, Anikhindi SA, Bansal N, Singla V, Khare S, Srivastava A. Is diabetes mellitus associated with mortality and severity of COVID-19? A meta-analysis. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):535-545. doi: 10.1016/j.dsx.2020.04.044. Epub 2020 May 6.

Reference Type BACKGROUND
PMID: 32408118 (View on PubMed)

Moro K, Nagahashi M, Ramanathan R, Takabe K, Wakai T. Resolvins and omega three polyunsaturated fatty acids: Clinical implications in inflammatory diseases and cancer. World J Clin Cases. 2016 Jul 16;4(7):155-64. doi: 10.12998/wjcc.v4.i7.155.

Reference Type BACKGROUND
PMID: 27458590 (View on PubMed)

Lordan R, Tsoupras A, Zabetakis I. Phospholipids of Animal and Marine Origin: Structure, Function, and Anti-Inflammatory Properties. Molecules. 2017 Nov 14;22(11):1964. doi: 10.3390/molecules22111964.

Reference Type BACKGROUND
PMID: 29135918 (View on PubMed)

Yu E, Malik VS, Hu FB. Cardiovascular Disease Prevention by Diet Modification: JACC Health Promotion Series. J Am Coll Cardiol. 2018 Aug 21;72(8):914-926. doi: 10.1016/j.jacc.2018.02.085.

Reference Type BACKGROUND
PMID: 30115231 (View on PubMed)

Phillips CM, Chen LW, Heude B, Bernard JY, Harvey NC, Duijts L, Mensink-Bout SM, Polanska K, Mancano G, Suderman M, Shivappa N, Hebert JR. Dietary Inflammatory Index and Non-Communicable Disease Risk: A Narrative Review. Nutrients. 2019 Aug 12;11(8):1873. doi: 10.3390/nu11081873.

Reference Type BACKGROUND
PMID: 31408965 (View on PubMed)

Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.

Reference Type BACKGROUND
PMID: 29897866 (View on PubMed)

Martinez-Gonzalez MA, Bes-Rastrollo M. Dietary patterns, Mediterranean diet, and cardiovascular disease. Curr Opin Lipidol. 2014 Feb;25(1):20-6. doi: 10.1097/MOL.0000000000000044.

Reference Type BACKGROUND
PMID: 24370845 (View on PubMed)

Bonaccio M, Di Castelnuovo A, De Curtis A, Costanzo S, Persichillo M, Donati MB, Cerletti C, Iacoviello L, de Gaetano G; Moli-sani Project Investigators. Adherence to the Mediterranean diet is associated with lower platelet and leukocyte counts: results from the Moli-sani study. Blood. 2014 May 8;123(19):3037-44. doi: 10.1182/blood-2013-12-541672. Epub 2014 Mar 31.

Reference Type BACKGROUND
PMID: 24687087 (View on PubMed)

Van Hylckama Vlieg A, Callas PW, Cushman M, Bertina RM, Rosendaal FR. Inter-relation of coagulation factors and d-dimer levels in healthy individuals. J Thromb Haemost. 2003 Mar;1(3):516-22. doi: 10.1046/j.1538-7836.2003.00080.x.

Reference Type BACKGROUND
PMID: 12871460 (View on PubMed)

Varraso R, Fung TT, Barr RG, Hu FB, Willett W, Camargo CA Jr. Prospective study of dietary patterns and chronic obstructive pulmonary disease among US women. Am J Clin Nutr. 2007 Aug;86(2):488-95. doi: 10.1093/ajcn/86.2.488.

Reference Type BACKGROUND
PMID: 17684223 (View on PubMed)

Sergi D, Boulestin H, Campbell FM, Williams LM. The Role of Dietary Advanced Glycation End Products in Metabolic Dysfunction. Mol Nutr Food Res. 2021 Jan;65(1):e1900934. doi: 10.1002/mnfr.201900934. Epub 2020 Apr 20.

Reference Type BACKGROUND
PMID: 32246887 (View on PubMed)

Hegazy MA, Fouad MM, Abd Elshafy SA, Abdelfatah D, Lithy RM, Abdelghani A, Ashoush OA. Beneficial role of healthy eating Index-2015 score & physical activity on COVID-19 outcomes. BMC Nutr. 2023 Oct 2;9(1):113. doi: 10.1186/s40795-023-00727-8.

Reference Type DERIVED
PMID: 37784193 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1003

Identifier Type: -

Identifier Source: org_study_id