Evaluating the controlled reopening of nightlife during the COVID-19 pandemic : a matched cohort study in Sitges, Spain, in May 2021 (Reobrim Sitges)

To assess the impact of relaxing the state of alarm restrictions on SARS-CoV-2 infections at 14 days among people attending reopened nightclub venues. Matched cohort study with a paired control group (1:5 ratio). Five small nightclubs with indoor areas and outdoor terraces, in a nightlife-restricted area in Sitges, Spain, on 20 May 2021. Wearing masks was mandatory, drinking was allowed and social distance was not required. Volunteers were selected through a convenience sampling. To attend the event, participants were required to be older than 17 years, with a negative rapid antigen diagnostic test (Ag-RDT) on the same afternoon, without a positive reverse-transcription PCR (RT-PCR) or Ag-RDT and/or symptoms associated with COVID-19 in the previous 7 days, to not having knowingly been in close contact with someone infected in the previous 10 days and to not have knowingly had close contact with someone with a suspicion of COVID-19 in the previous 48 hours. A control group was paired by exact age, gender, residence municipality, socioeconomic index, previous SARS-CoV-2-confirmed infection and vaccination status, in a 1:5 ratio, from the primary care electronic health records. Evidence of infection at electronic health records by SARS-CoV-2 at 14-day follow-up. Among the 391 participants (median age 37 years; 44% (n=173) women), no positive SARS-CoV-2 cases were detected at 14 days, resulting in a cumulative incidence estimation of 0 (95% CI 0 to 943) per 100 000 inhabitants. In the control group, two cases with RT-PCR test were identified, resulting in a cumulative incidence of 102.30 (12.4 to 369) per 100 000 inhabitants. Nightlife attendance under controlled conditions and with a requirement for a negative Ag-RDT was not associated with increased transmissibility of SARS-CoV-2 in a pandemic context of low infection rates. In such circumstances, secure opening of the nightlife sector was possible, under reduced capacity and controlled access by Ag-RDT, and environments where compliance with sanitary measures are maintainable

Heme iron intake and risk of new-onset diabetes in a Mediterranean population at high risk of cardiovascular disease: an observational cohort analysis

BACKGROUND: Several epidemiological studies have observed an increased risk of type 2 diabetes mellitus (T2DM) among subjects with a higher consumption of red and processed meat. Heme iron intake has been directly associated with a higher risk of T2DM in healthy adult Chinese and U.S populations. The objective of the present study was to evaluate the association between heme iron intake and the incidence of T2DM in a Mediterranean population at high cardiovascular risk. METHODS: We assessed a subset of participants in the PREDIMED trial as an observational cohort, followed up for a maximum of eight years. We initially included 1073 non-diabetic subjects (57.1% women) aged 67.3 ± 6.0 years, at high cardiovascular risk. Diet was assessed at the study baseline using a validated, semi-quantitative food frequency questionnaire. RESULTS: During the follow-up period 131 diabetics were newly diagnosed. The risk of developing T2DM was assessed using baseline heme iron intake and proportional hazard models, first unadjusted, then adjusted for energy, and finally adjusted for dietary, anthropometric, socio-demographic and lifestyle variables. Significant direct associations with the incidence of T2DM were found for heme iron (Hazard Ratio [HR] 1.30, 95% confidence interval [CI], 1.02 to 1.66). Secondarily, we have also observed that coffee (HR:0.93, 95% CI, 0.89 to 0.98) and alcoholic beverages (HR: 1.02, 95% CI, 1.01 to 1.04) were also found to reduce and increase the risk of T2DM, respectively. CONCLUSION: High dietary intake of heme iron was associated with an increased risk of developing T2DM in a Mediterranean population at high cardiovascular risk. TRIAL REGISTRATION: Identifier: ISRCTN35739639

Dietary intake of phylloquinone is related to a reduced risk of all-cause mortality: the predimed study

Resumen del trabajo presentado en el 20th International Congress of Nutrition, celebrado en Granada (España) del 15 al 20 de septiembre de 2013.[Background and objectives]: Vitamin K has been associated with a reduced risk of CHD and fatal cancer. Dietary menaquinones intake has been associated with cancer mortality. However, the association between the dietary intake of vitamin K and all-cause mortality has not been evaluated in a Mediterranean population at high cardiovascular risk.[Methods]: A prospective analysis was conducted in 7216 participants in the framework of the PREDIMED cohort (median follow-up: 4.8y). Energy and nutrient intakes were evaluated using a previously validated 137-item food frequency questionnaire. Dietary phylloquinone and menaquinone intake was calculated using the USDA database and previous published Abstracts Ann Nutr Metab 2013;63(suppl 1):1– 1960 921 data, respectively. All-cause mortality was verified by medical records and consultation of National Death Index. Cox proportional hazard models were fitted to assess the relative risk of all-cause mortality.[Results]: At baseline, energy-adjusted dietary phylloquinone intake was associated with a significantly reduced risk of all-cause mortality after controlling for potential confounders (HR: 0.64; 95% CI: 0.43, 0.96). No significant associations were found between quartiles of energy adjusted dietary menaquinones intake and risk of all-cause mortality. In a longitudinal manner, subjects who increase their consumption of vitamin K, phylloquinone or menaquinone, had a lower risk of allcause mortality (HR: 0.58; 95% CI: 0.45, 0.74 and HR: 0.59; 95% CI: 0.45, 0.78, respectively) compared with subjects who decrease their consumption.[Conclusions]: The results showed that an increase of dietary intake of vitamin K is related with a reduced risk of all-cause mortality in a Mediterranean population at high cardiovascular risk

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study

<p>Abstract</p> <p>Background</p> <p>Safety for diabetic patients means providing the most suitable treatment for each type of diabetic in order to improve monitoring and to prevent the adverse effects of drugs and complications arising from the disease. The aim of this study is to analyze the effect of imparting educational interventions to health professionals regarding the safety of patients with Diabetes Mellitus (DM).</p> <p>Methods</p> <p><it>Design</it>: A cluster randomized trial with a control group.</p> <p><it>Setting and sample</it>: The study analyzed ten primary healthcare centres (PHC) covering approximately 150,000 inhabitants. Two groups of 5 PHC were selected on the basis of their geographic location (urban, semi-urban and rural), their socio-economic status and the size of their PHC, The interventions and control groups were assigned at random. The study uses computerized patient records to individually assess subjects aged 45 to 75 diagnosed with type 1 and type 2 DM, who met the inclusion conditions and who had the variables of particular interest to the study.</p> <p><it>Trial</it>: The educational interventions consisted of a standardized teaching course aimed at doctors and nurses. The course lasted 6 hours and was split into three 2-hour blocks with subsequent monthly refresher courses.</p> <p><it>Measurement</it>: For the health professionals, the study used the <it>Diabetes Attitude Scale </it>(DAS-3) to assess their attitudes and motivation when monitoring diabetes. For the patients, the study assessed factors related to their degree of control over the disease at onset, 6, 12 and 24 months.</p> <p><it>Main variables</it>: levels of HbA1c.</p> <p><it>Analysis</it>: The study analyzed the effect of the educational interventions both on the attitudes and motivations of health professionals and on the degree of control over the diabetes in both groups.</p> <p>Discussion</p> <p>Imparting educational interventions to health professionals would improve the monitoring of diabetic patients. The most effective model involves imparting the course to both doctors and nurses. However, these models have not been tested on our Spanish population within the framework of primary healthcare.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01087541">NCT01087541</a></p

Primary prevention of cardiovascular disease with a Mediterranean diet

BACKGROUND: Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events. METHODS: In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years. RESULTS: A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported. CONCLUSIONS: Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events

Olive oil intake and risk of cardiovascular disease and mortality in the PREDIMED Study

Background: It is unknown whether individuals at high cardiovascular risk sustain a benefit in cardiovascular disease from increased olive oil consumption. The aim was to assess the association between total olive oil intake, its varieties (extra virgin and common olive oil) and the risk of cardiovascular disease and mortality in a Mediterranean population at high cardiovascular risk. Methods: We included 7,216 men and women at high cardiovascular risk, aged 55 to 80 years, from the PREvención con DIeta MEDiterránea (PREDIMED) study, a multicenter, randomized, controlled, clinical trial. Participants were randomized to one of three interventions: Mediterranean Diets supplemented with nuts or extra-virgin olive oil, or a control low-fat diet. The present analysis was conducted as an observational prospective cohort study. The median follow-up was 4.8 years. Cardiovascular disease (stroke, myocardial infarction and cardiovascular death) and mortality were ascertained by medical records and National Death Index. Olive oil consumption was evaluated with validated food frequency questionnaires. Multivariate Cox proportional hazards and generalized estimating equations were used to assess the association between baseline and yearly repeated measurements of olive oil intake, cardiovascular disease and mortality. Results: During follow-up, 277 cardiovascular events and 323 deaths occurred. Participants in the highest energy-adjusted tertile of baseline total olive oil and extra-virgin olive oil consumption had 35% (HR: 0.65; 95% CI: 0.47 to 0.89) and 39% (HR: 0.61; 95% CI: 0.44 to 0.85) cardiovascular disease risk reduction, respectively, compared to the reference. Higher baseline total olive oil consumption was associated with 48% (HR: 0.52; 95% CI: 0.29 to 0.93) reduced risk of cardiovascular mortality. For each 10 g/d increase in extra-virgin olive oil consumption, cardiovascular disease and mortality risk decreased by 10% and 7%, respectively. No significant associations were found for cancer and all-cause mortality. The associations between cardiovascular events and extra virgin olive oil intake were significant in the Mediterranean diet intervention groups and not in the control group. Conclusions: Olive oil consumption, specifically the extra-virgin variety, is associated with reduced risks of cardiovascular disease and mortality in individuals at high cardiovascular risk. Trial registration This study was registered at controlled-trials.com (http://www.controlled-trials.com/ISRCTN35739639). International Standard Randomized Controlled Trial Number (ISRCTN): 35739639. Registration date: 5 October 2005

Olive oil intake and risk of cardiovascular disease and mortality in the PREDIMED Study

It is unknown whether individuals at high cardiovascular risk sustain a benefit in cardiovascular disease from increased olive oil consumption. The aim was to assess the association between total olive oil intake, its varieties (extra virgin and common olive oil) and the risk of cardiovascular disease and mortality in a Mediterranean population at high cardiovascular risk. Methods: We included 7,216 men and women at high cardiovascular risk, aged 55 to 80 years, from the PREvencion con DIeta MEDiterranea (PREDIMED) study, a multicenter, randomized, controlled, clinical trial. Participants were randomized to one of three interventions: Mediterranean Diets supplemented with nuts or extra-virgin olive oil, or a control low-fat diet. The present analysis was conducted as an observational prospective cohort study. The median follow-up was 4.8 years. Cardiovascular disease (stroke, myocardial infarction and cardiovascular death) and mortality were ascertained by medical records and National Death Index. Olive oil consumption was evaluated with validated food frequency questionnaires. Multivariate Cox proportional hazards and generalized estimating equations were used to assess the association between baseline and yearly repeated measurements of olive oil intake, cardiovascular disease and mortality. Results: During follow-up, 277 cardiovascular events and 323 deaths occurred. Participants in the highest energy-adjusted tertile of baseline total olive oil and extra-virgin olive oil consumption had 35% (HR: 0.65; 95% CI: 0.47 to 0.89) and 39% (HR: 0.61; 95% CI: 0.44 to 0.85) cardiovascular disease risk reduction, respectively, compared to the reference. Higher baseline total olive oil consumption was associated with 48% (HR: 0.52; 95% CI: 0.29 to 0.93) reduced risk of cardiovascular mortality. For each 10 g/d increase in extra-virgin olive oil consumption, cardiovascular disease and mortality risk decreased by 10% and 7%, respectively. No significant associations were found for cancer and all-cause mortality. The associations between cardiovascular events and extra virgin olive oil intake were significant in the Mediterranean diet intervention groups and not in the control group. Conclusions: Olive oil consumption, specifically the extra-virgin variety, is associated with reduced risks of cardiovascular disease and mortality in individuals at high cardiovascular risk

Effects of the Ser326Cys Polymorphism in the DNA Repair OGG1 Gene on Cancer, Cardiovascular, and All-Cause Mortality in the PREDIMED Study: Modulation by Diet

Background: Oxidatively induced DNA damage, an important factor in cancer etiology, is repaired by oxyguanine glycosylase 1 (OGG1). The lower repair capacity genotype (homozygote Cys326Cys) in the OGG1-rs1052133 (Ser326Cys) polymorphism has been associated with cancer risk. However, no information is available in relation to cancer mortality, other causes of death, and modulation by diet. Objective: Our aim was to evaluate the association of the OGG1-rs1052133 with total, cancer, and cardiovascular disease (CVD) mortality and to analyze its modulation by the Mediterranean diet, focusing especially on total vegetable intake as one of the main characteristics of this diet. Design: Secondary analysis in the PREDIMED (Prevención con Dieta Mediterránea) trial is a randomized, controlled trial conducted in Spain from 2003 to 2010. Participants/setting: Study participants (n=7,170) were at high risk for CVD and were aged 55 to 80 years. Intervention Participants were randomly allocated to two groups with a Mediterranean diet intervention or a control diet. Vegetable intake was measured at baseline. Main outcome measures Main outcomes: were all-cause, cancer, and CVD mortality after a median follow-up of 4.8 years. Statistical analyses: Multivariable-adjusted Cox regression models were fitted. Results: Three hundred eighteen deaths were detected (cancer, n=127; CVD, n=81; and other, n=110). Cys326Cys individuals (prevalence 4.2%) presented higher total mortality rates than Ser326-carriers (P=0.009). The multivariable-adjusted hazard ratio for Cys326Cys vs Ser326-carriers was 1.69 (95% CI 1.09 to 2.62; P=0.018). This association was greater for CVD mortality (P=0.001). No relationship was detected for cancer mortality in the whole population (hazard ratio 1.07; 95% CI 0.47 to 2.45; P=0.867), but a significant age interaction (P=0.048) was observed, as Cys326Cys was associated with cancer mortality in participants <66.5 years (P=0.029). Recessive effects limited our ability to investigate Cys326Cys×diet interactions for cancer mortality. No statistically significant interactions for total or CVD mortality were found for the Mediterranean diet intervention. However, significant protective interactions for CVD mortality were found for vegetable intake (hazard ratio interaction per standard deviation 0.42; 95% CI 0.18 to 0.98; P=0.046). Conclusions: In this population, the Cys326Cys-OGG1 genotype was associated with all-cause mortality, mainly CVD instead of cancer mortality. Additional studies are needed to provide further evidence on its dietary modulation

Factors associated with commencing smoking in 12-year-old students in Catalonia (Spain): a cross-sectional population-based study

<p>Abstract</p> <p>Background</p> <p>Over the last decade notable progress has been made in developed countries on monitoring smoking although experimenting with cigarettes and smoking in young people remains a serious public health problem. This paper reports a cross-sectional study at the beginning of the 3-year follow-up community study TA_BES. The aim was to study the prevalence of smoking in addition to determining predictive factors for when smoking commences in a representative population of 12-year-old first year compulsory secondary education students.</p> <p>Methods</p> <p>Twenty-nine secondary schools (N = 29) from an area of Catalonia participated in the study. In these schools 2245 students answered a questionnaire to study the attitudes, behaviors, and tobacco consumption in the subject's surrounding circle and family in relation to smoking; carbon monoxide measurements were taken by means of co-oximetry on 2 different occasions. A smoker was defined as a student who had smoked daily or occasionally in the last 30 days. For non-smokers the criteria of not considering was set up for those who answered that in the future they would not be smokers and considering those who answered that they did not rule out becoming a smoker in the future.</p> <p>Results</p> <p>Among the total 2245 students included in the analysis 157(7%) were classified as smokers. Among non-smokers we differentiated between those not considering smoking 1757 (78.3%) and those considering smoking 288 (12.8%).</p> <p>Age is among the factors related to commencing smoking. The risk of becoming a smoker increases 2.27 times/year. The influence of the group of friends with a very high risk for boys OR 149.5 and lower, albeit high, in girls OR 38.1. Tobacco consumption of parents produces different effects in young people. A smoking father does not produce alterations in the smoking behavior of young people. However having a smoking mother or former smoking is a risk factor for boys and a protective factor for girls.</p> <p>We detected a gradual risk of becoming a smoker by means of the co-oximetry test. A boy/girl with a test between 6 p.p.m and 10 p.p.m increased the probability of smoking by 2.29 and co-oximetry values > 10 p.p.m multiplied the risk 4 times over.</p> <p>Conclusions</p> <p>Results indicate that the age of commencing smoking is maintained in spite of prevalence having decreased in the last few years. The risk factors identified should be used to involve families and the educational community by offering them tobacco weaning programmes.</p