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Enhancing immunity in viral infections, with special emphasis on COVID-19: A review.
Jayawardena, R, Sooriyaarachchi, P, Chourdakis, M, Jeewandara, C, Ranasinghe, P
Diabetes & metabolic syndrome. 2020;14(4):367-382
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A healthy immune system is one of the most important weapons in relation to the current pandemic of COVID-19 where no effective preventive and curative medicine is available. The main aim of this study was to evaluate the evidence on enhancing immunity in viral infections. This review focuses on influenza-like viral infections; however, other studies on viral infections have also been included. It included 43 articles of which 13 were on vitamins, 8 on minerals, 18 on nutraceuticals and 4 on probiotics. Results indicate that: - vitamin supplementation, especially vitamin D may be beneficial in people who are either deficient or insufficient. - adverse effects of vitamin E supplementation on the immune response have been reported. - there are several beneficial nutraceuticals, however their efficacy and safety depend on their ingredients, as well as various other factors including, methods of extraction. - in addition to basic hygienic practices, proper dietary and lifestyle behaviours are essential for prevention and treatment of respiratory viral diseases. Authors conclude that achieving recommended amounts of calories and micronutrient will be a challenge and elective micronutrient supplementations may be beneficial especially for vulnerable populations such as the elderly.
Abstract
BACKGROUND AND AIMS Balanced nutrition which can help in maintaining immunity is essential for prevention and management of viral infections. While data regarding nutrition in coronavirus infection (COVID-19) are not available, in this review, we aimed to evaluate evidence from previous clinical trials that studied nutrition-based interventions for viral diseases (with special emphasis on respiratory infections), and summarise our observations. METHODS A systematic search strategy was employed using keywords to search the literature in 3 key medical databases: PubMed®, Web of Science® and SciVerse Scopus®. Studies were considered eligible if they were controlled trials in humans, measuring immunological parameters, on viral and respiratory infections. Clinical trials on vitamins, minerals, nutraceuticals and probiotics were included. RESULTS A total of 640 records were identified initially and 22 studies were included from other sources. After excluding duplicates and articles that did not meet the inclusion criteria, 43 studies were obtained (vitamins: 13; minerals: 8; nutraceuticals: 18 and probiotics: 4). Among vitamins, A and D showed a potential benefit, especially in deficient populations. Among trace elements, selenium and zinc have also shown favourable immune-modulatory effects in viral respiratory infections. Several nutraceuticals and probiotics may also have some role in enhancing immune functions. Micronutrients may be beneficial in nutritionally depleted elderly population. CONCLUSIONS We summaries possible benefits of some vitamins, trace elements, nutraceuticals and probiotics in viral infections. Nutrition principles based on these data could be useful in possible prevention and management of COVID-19.
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Mediterranean Diet and its Benefits on Health and Mental Health: A Literature Review.
Ventriglio, A, Sancassiani, F, Contu, MP, Latorre, M, Di Slavatore, M, Fornaro, M, Bhugra, D
Clinical practice and epidemiology in mental health : CP & EMH. 2020;16(Suppl-1):156-164
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Mediterranean Diet (MD) is currently considered one of the healthiest dietary models worldwide due to the high intake of antioxidants, dietary fibre, monounsaturated and omega-3 fatty acids, phytosterols and probiotics. The aim of this review was to present current literature showing evidence on the possible impact of MD on health and mental health. The review was based on 27 articles of which 13 were carried out in Spain, 3 in the USA, 3 in Italy, 4 in Australia and 4 in other EU countries. Literature shows that MD improves: - metabolic cardiovascular parameters with a reduced incidence of major cardiovascular events by approximately 30%. - metabolic balance in patients affected by type 2 diabetes mellitus. - biochemical markers for metabolic disorders as well as in patients at risk of specific cancer diseases. Additionally, not enough data is available on the MD effects on specific psychopathological issues. In fact, besides adherence to MD, other factors - which should be further investigated - also play a role in the effectiveness of the MD. Authors conclude that further studies are needed to address the efficacy of diet as an adjunctive treatment for mental disorders as well as for the management of comorbid cardiovascular and metabolic issues.
Abstract
Mediterranean Diet (MD) is currently considered one of the most healthy dietary models worldwide. It is generally based on the daily intake of fruit and vegetables, whole grains, legumes, nuts, fish, white meats, and olive oil. It may also include moderate consumption of fermented dairy products, a low intake of red meat, and red/white wine during the main course. Even if the effect of MD on cancer prevention as well as on human metabolic and cardiovascular balance has been discussed, including the quality of life of the exposed population, the putative effects on mental health are still not properly investigated. This narrative review reports on some emerging pieces of evidence on the possible impact of MD on general health and the outcome of psychiatric disorders (e.g., major depression, anxiety) and encourages further studies to test the benefits of healthy food selection on the health of the general population.
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Ultra-Processed Foods and Health Outcomes: A Narrative Review.
Elizabeth, L, Machado, P, Zinöcker, M, Baker, P, Lawrence, M
Nutrients. 2020;12(7)
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Ultra-processed food (UPF) is prevalent in diets world-wide. This review aims to look at the results of studies that have investigated associations between levels of UPF consumption and health outcomes on healthy participants. 43 studies were reviewed; studies covered all age groups (including children and adolescents) in a number of different countries. Studies looked at overweight, obesity and cardio-metabolic risks as outcomes as well as cancer, cardiovascular disease, type 2 diabetes, mortality, gastrointestinal disorders, depression, frailty and asthma. In 37 studies, there was at least one statistically significant association between UPF exposure and at least one adverse health outcome. No study reported an association between UPF exposure and beneficial health outcomes. This review has shown that a high intake of UPFs is associated with a range of adverse health outcomes, disorders and conditions. This has the potential to significantly influence the global burden of disease. As well as this; evidence suggests a higher risk of all-cause mortality with high consumption of UPFs. No study reported an association between UPF and beneficial health outcomes. The review has also shown beneficial outcomes were associated with diets higher in unprocessed and minimally processed foods.
Abstract
The nutrition literature and authoritative reports increasingly recognise the concept of ultra-processed foods (UPF), as a descriptor of unhealthy diets. UPFs are now prevalent in diets worldwide. This review aims to identify and appraise the studies on healthy participants that investigated associations between levels of UPF consumption and health outcomes. This involved a systematic search for extant literature; integration and interpretation of findings from diverse study types, populations, health outcomes and dietary assessments; and quality appraisal. Of 43 studies reviewed, 37 found dietary UPF exposure associated with at least one adverse health outcome. Among adults, these included overweight, obesity and cardio-metabolic risks; cancer, type-2 diabetes and cardiovascular diseases; irritable bowel syndrome, depression and frailty conditions; and all-cause mortality. Among children and adolescents, these included cardio-metabolic risks and asthma. No study reported an association between UPF and beneficial health outcomes. Most findings were derived from observational studies and evidence of plausible biological mechanisms to increase confidence in the veracity of these observed associations is steadily evolving. There is now a considerable body of evidence supporting the use of UPFs as a scientific concept to assess the 'healthiness' of foods within the context of dietary patterns and to help inform the development of dietary guidelines and nutrition policy actions.
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Endocrine and metabolic aspects of the COVID-19 pandemic.
Marazuela, M, Giustina, A, Puig-Domingo, M
Reviews in endocrine & metabolic disorders. 2020;21(4):495-507
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Endocrine and metabolic related diseases such as diabetes and obesity may increase the risk of developing severe Covid-19 and as a result these diseases could be severely affected by Covid-19 infection. This very large review paper looked at over 100 studies and outlined the interrelationship between Covid-19 infection and several endocrine diseases. Diabetes, obesity, pituitary-hypothalamic function, thyroid function, Cushing's syndrome and adrenal function were all reviewed. No aim was stated. Data on individuals with obesity and diabetes indicated an increased risk for severe Covid-19 infection, hospitalisation and mortality. Data surrounding pituitary-hypothalamic function, thyroid function, Cushing's syndrome and adrenal function was less abundant, however neurological issues in Covid-19 patients suggested an involvement of the pituitary and hypothalamus. In lieu of sufficient data the author commented on the possible similarities between severe acute respiratory syndrome coronavirus with the Covid-19 virus. A number of management strategies were discussed such as the use of vitamin D, oxytocin and melatonin, however the authors commented on the lack of data regarding oxytocin and melatonin in Covid-19 patients, but mechanistic data suggested they might be of use. No overall conclusions were drawn on the findings. Clinicians could use this paper to understand how patients with pre-existing endocrine and metabolic conditions may be at a higher risk of more severe Covid-19 and if contracted could exacerbate their pre-existing condition. These patients could require constant monitoring and additional measures to avoid contracting Covid-19. Supplements such as vitamin D, oxytocin or melatonin could be therapeutic, however more data needs to be reviewed.
Abstract
COVID-19 infection has tremendously impacted our daily clinical practice as well as our social living organization. Virtually all organs and biological systems suffer from this new coronavirus infection, either because the virus targets directly specific tissues or because of indirect effects. Endocrine diseases are not an exception and some of endocrine organs are at risk of direct or indirect lesion by COVID-19. Although there is still no evidence of higher predisposition to contract the infection in patients with diabetes and/or obesity, the coexistence of these conditions contributes to a worse prognosis because both conditions confer an impaired immunologic system. Cytokines storm can be amplified by these two latter conditions thereby leading to multisystemic failure and death. Glycaemic control has been demonstrated to be crucial to avoiding long hospital stays, ICU requirement and also prevention of excessive mortality. Endocrine treatment modifications as a consequence of COVID-19 infection are required in a proactive manner, in order to avoid decompensation and eventual hospital admission. This is the case of diabetes and adrenal insufficiency in which prompt increase of insulin dosage and substitutive adrenal steroids through adoption of the sick day's rules should be warranted, as well as easy contact with the health care provider through telematic different modalities. New possible endocrinological targets of COVID-19 have been recently described and warrant a full study in the next future.
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Effect of Smartphone-Based Lifestyle Coaching App on Community-Dwelling Population With Moderate Metabolic Abnormalities: Randomized Controlled Trial.
Cho, SMJ, Lee, JH, Shim, JS, Yeom, H, Lee, SJ, Jeon, YW, Kim, HC
Journal of medical Internet research. 2020;22(10):e17435
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Metabolic disorders are established precursors to cardiovascular disease. The aim of the study was to evaluate the longitudinal effect of smartphone-based health care app on metabolic parameters in a sample of the general population with moderate metabolic abnormalities. The study is a single-blind 3-arm parallel-design randomized controlled trial delivering a 6-month primary prevention program via mobile app. One hundred twenty-nine smartphone users, aged between 30-59 years with at least 2 metabolic abnormalities, have been recruited. Results showed that the simultaneous diet/exercise logging and lifestyle coaching yielded greater body weight reduction, specifically via body fat mass reduction. On the other hand, the systolic blood pressure did not change notably between the 3 groups at any follow-up examinations. Authors conclude that future studies focusing on comparative effectiveness using alternative study designs are needed to integrate these apps in everyday lives and clinic practice.
Abstract
BACKGROUND Metabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications. OBJECTIVE We assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting. METHODS In this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat. RESULTS Between October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean -10.95, SD 2.09 mmHg; app only: mean -7.29, SD 1.83 mmHg; app with personalized coaching: mean -7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean -0.12, SD 0.30 kg; app only: mean -0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only: mean -0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean -0.79, SD 0.38 kg; P=.08). CONCLUSIONS Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention. TRIAL REGISTRATION ClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271.
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Obesity, Cardiovascular Disease, and Influenza: How Are They Connected?
Gutiérrez-Spillari, L, Palma M, G, Aceituno-Melgar, J
Current tropical medicine reports. 2020;7(3):92-97
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Retrospective studies demonstrate that during the 2009 H1N1 pandemic, obesity was identified as a risk factor for hospitalization, mechanical ventilation, and mortality upon infection. This study is a review which focuses on how obesity and cardiovascular disease impact influenza response. A higher body mass index and metabolic syndrome in patients with influenza have shown an increased risk and length of hospitalization, increased disease severity, morbidity, and mortality during lower respiratory tract infections. Obesity causes a chronic state of inflammation in a generalized and constant way with negative effects on immunity. In fact, obese people have delayed immune responses to influenza virus infection and experience slower recovery from the disease. Thus, recent recommendation advocates the priority of vaccination against influenza in obese patients. Furthermore, cardiovascular diseases, such as ischemic heart disease and heart failure combined with influenza A infection, can trigger acute heart failure exacerbations that increase the overall mortality in a hospitalized setting. The cardioprotective mechanism of influenza vaccination may not function effectively in obese cohorts, thus authors conclude that in order to prevent these complications and in the absence of special consideration treatments for this population, a weight-loss approach is highly recommended.
Abstract
PURPOSE OF REVIEW To better understand the impact of obesity and cardiovascular diseases on influenza A infection. RECENT FINDINGS This infection could have detrimental outcomes in obese patients with cardiovascular diseases, such as an increased risk, length of hospitalization, disease severity, morbidity, and mortality. Nevertheless, there also might be some cardioprotective benefits associated with influenza vaccination, such as a reduced mortality, hospitalization, and acute coronary syndromes, in patients with coronary heart disease and/or heart failure. SUMMARY Obesity negatively impacts immune function and host defense. Recent studies report obesity to be an independent risk factor for increased morbidity and mortality following infection. Obese patients might need special considerations in the treatment; however, there is not enough evidence to fully comprehend the mechanisms behind the reduced immunocompetence when influenza A infection occurs. Future studies should focus on special consideration treatments when the patients have not been vaccinated and have cardiovascular diseases.
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Non-nutritive Sweeteners and Their Associations with Obesity and Type 2 Diabetes.
Walbolt, J, Koh, Y
Journal of obesity & metabolic syndrome. 2020;29(2):114-123
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Nutritive sweeteners (NS) contribute to overall caloric intake, and their adverse effects on metabolic health are well known. Non-nutritive sweeteners (NNS) on the other hand, have negligible or no calorific value and are therefore used as replacement of NS to negate their associated health risks. Whilst the consumption of NNS has steadily increased over the recent years, so has the evidence questioning their benefits. Some research suggesting that NNS could be an indirect contributor to the development of metabolic diseases. This review presents a brief compilation of current knowledge relating to NNS and metabolic syndrome, obesity, type 2 diabetes, and cardiovascular disease. Summarised are findings from randomised controlled trials (RCT), prospective cohort studies, observations from animal studies and recent microbiome research. The authors noted that NNS frequently exerted negative influences on health in prospective cohort studies, which observed selected population groups over time. Whilst in controlled trials, NNS often showed neutral or positive health benefits. Following a discussion of possible causes leading to such variations and conflicting outcomes, the authors called for more carefully designed studies to evaluate NNS and their metabolic influences. For clinicians, it may be worth considering further evidence relating to the individual types of sweeteners when evaluating NNS and their risks and benefits on cardiometabolic health.
Abstract
Evidence linking the excessive consumption of nutritive sweeteners (NS) to adverse metabolic health outcomes has led to an increase in consumption of non-nutritive sweeteners (NNS), particularly among the obese and individuals with diabetes. NNS are characterized by having zero-to-negligible caloric load, while also having a sweet taste. They are utilized as a replacement for traditional NS to reduce energy intake and to limit carbohydrate-related negative health outcomes. However, recent studies have suggested that NNS may actually contribute to the development or worsening of metabolic diseases, including metabolic syndrome, obesity, type 2 diabetes, and cardiovascular disease. Thus, it is imperative to understand the NNS efficacy and the relationship between NNS and metabolic diseases.
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Early Nutritional Interventions with Zinc, Selenium and Vitamin D for Raising Anti-Viral Resistance Against Progressive COVID-19.
Alexander, J, Tinkov, A, Strand, TA, Alehagen, U, Skalny, A, Aaseth, J
Nutrients. 2020;12(8)
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The novel coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome-coronavirus-2), causing COVID-19, is by far the most dangerous coronavirus ever identified, capable of infecting not only animals, but also humans across the globe. The aim of this narrative review was to present recent clinical data on the role of selenium, zinc, and vitamin D in the protection against bronchopulmonary infections, as well as the existing indications of their impact on COVID-19. The review shows that evidence that the micronutrients zinc, selenium, and vitamin D might be involved in the course and outcome of the COVID-19 disease is observational and weak. However, based on the treatment of other viral infections, nutritive supplements administered at an early stage of infection was important for enhancing host resistance against RNA viral infections, which might also include severe COVID-19. Authors recommend early outpatient nutritional intervention in SARS-CoV-2 exposed or high-risk subjects, preferably before specific and supportive treatment.
Abstract
OBJECTIVES The novel coronavirus infection (COVID-19) conveys a serious threat globally to health and economy because of a lack of vaccines and specific treatments. A common factor for conditions that predispose for serious progress is a low-grade inflammation, e.g., as seen in metabolic syndrome, diabetes, and heart failure, to which micronutrient deficiencies may contribute. The aim of the present article was to explore the usefulness of early micronutrient intervention, with focus on zinc, selenium, and vitamin D, to relieve escalation of COVID-19. METHODS We conducted an online search for articles published in the period 2010-2020 on zinc, selenium, and vitamin D, and corona and related virus infections. RESULTS There were a few studies providing direct evidence on associations between zinc, selenium, and vitamin D, and COVID-19. Adequate supply of zinc, selenium, and vitamin D is essential for resistance to other viral infections, immune function, and reduced inflammation. Hence, it is suggested that nutrition intervention securing an adequate status might protect against the novel coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome - coronavirus-2) and mitigate the course of COVID-19. CONCLUSION We recommended initiation of adequate supplementation in high-risk areas and/or soon after the time of suspected infection with SARS-CoV-2. Subjects in high-risk groups should have high priority as regards this nutritive adjuvant therapy, which should be started prior to administration of specific and supportive medical measures.
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Thrombosis and COVID-19: The Potential Role of Nutrition.
Tsoupras, A, Lordan, R, Zabetakis, I
Frontiers in nutrition. 2020;7:583080
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COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). The lungs seem to be the initial target organ of SARS-CoV-2, however it became clear that other systems including the cardiovascular and neurological systems were also involved. Literature shows that thrombotic complications are a significant risk factor for COVID-19 patients. In fact, adopting healthy dietary habits: - will prevent the onset of non-communicable diseases, which is a significant risk factor for the development of COVID-19, - may support the immune system to lessen the severity of an infection, and - may prevent the onset of severe thrombotic complications due to the presence of bioactive compounds with antiplatelet effects (for non-infected individuals, especially those with or at increased risk of underlying non-communicable diseases). Authors emphasise on the importance of establishing clinical trials to investigate potential pharmacological and nutritional mitigation strategies to prevent thrombotic complications as a result of severe COVID-19 infection.
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), responsible for the coronavirus disease (COVID-19), is a contagion that has rapidly spread around the globe. COVID-19 has caused significant loss of life and disrupted global society at a level never before encountered. While the disease was predominantly characterized by respiratory symptoms initially, it became clear that other systems including the cardiovascular and neurological systems were also involved. Several thrombotic complications were reported including venous thrombosis, vasculitis, cardiomyopathy, and stroke. Thrombosis and inflammation are implicated in various non-communicable diseases (NCDs). This is of significant concern as people with pre-existing conditions such as cardiovascular disorders, renal disorders, obesity, metabolic syndrome, and diabetes are at greater risk of severe COVID-19 infection. Consequently, the research surrounding the use of anticoagulants, antiplatelet, and antithrombotic strategies for prophylaxis and treatment of COVID-19 is of critical importance. The adoption of a healthy diet, physical exercise, and lifestyle choices can reduce the risk factors associated with NCDs and the thrombo-inflammatory complications. In this review, these thrombotic complications and potential foods, nutraceuticals, and the antithrombotic constituents within that may prevent the onset of severe thrombotic complications as a result of infection are discussed. While nutrition is not a panacea to tackle COVID-19, it is apparent that a patient's nutritional status may affect patient outcomes. Further intensive research is warranted to reduce to incidence of thrombotic complications.
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Consumption of ultra-processed foods and health outcomes: a systematic review of epidemiological studies.
Chen, X, Zhang, Z, Yang, H, Qiu, P, Wang, H, Wang, F, Zhao, Q, Fang, J, Nie, J
Nutrition journal. 2020;19(1):86
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Unhealthy diets are recognized as a major determinant of the occurrence of non-communicable diseases (NCDs). The aim of this study was to summarize the evidence for the association between ultra-processed food (UPFs) consumption and health outcomes. This study is a systemic review of 20 published epidemiological studies (12 cohort and 8 cross-sectional studies), with a total of 334,114 participants and 10 diseases. Results indicate a positive association between UPFs consumption and risk of all-cause mortality, overall cardiovascular diseases, coronary heart diseases, cerebrovascular diseases, hypertension, metabolic syndrome, overweight and obesity, depression, irritable bowel syndrome, overall cancer, postmenopausal breast cancer, gestational obesity, adolescent asthma and wheezing, and frailty. However, on the contrary, there was not an obvious association with cardiovascular disease mortality, prostate and colorectal cancer, gestational diabetes mellitus and gestational overweight. Authors conclude that their findings encouraged a decrease in UPFs consumption and an increase in the proportion of unprocessed or minimally processed foods, such as fruits and vegetables.
Abstract
BACKGROUND Consumption of ultra-processed foods (UPFs) plays a potential role in the development of obesity and other diet-related noncommunicable diseases (NCDs), but no studies have systematically focused on this. This study aimed to summarize the evidence for the association between UPFs consumption and health outcomes. METHODS A comprehensive search was conducted in PubMed, Embase, and Web of Science to identify all relevant studies. Epidemiological studies were included, and identified studies were evaluated for risk of bias.A narrative review of the synthesized findings was provided to assess the association between UPFs consumption and health outcomes. RESULTS 20 studies (12 cohort and 8 cross-sectional studies) were included in the analysis, with a total of 334,114 participants and 10 health outcomes. In a narrative review, high UPFs consumption was obviously associated with an increased risk of all-cause mortality, overall cardiovascular diseases, coronary heart diseases, cerebrovascular diseases, hypertension, metabolic syndrome, overweight and obesity, depression, irritable bowel syndrome, overall cancer, postmenopausal breast cancer, gestational obesity, adolescent asthma and wheezing, and frailty. It showed no significant association with cardiovascular disease mortality, prostate and colorectal cancers, gestational diabetes mellitus and gestational overweight. CONCLUSIONS This study indicated a positive association between UPFs consumption and risk of several health outcomes. Large-scale prospective designed studies are needed to confirm our findings.