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We assessed if a 17-item score capturing adherence to a traditional Mediterranean diet (MedDiet) was associated with better health-related quality of life among older Spanish men and women with overweight or obesity harboring the metabolic syndrome. We analyzed baseline data from 6430 men and women (age 55–70 years) participating in the PREDIMED-Plus study. PREDIMED-Plus is a multi-centre randomized trial testing an energy-restricted MedDiet combined with promotion of physical activity and behavioral therapy for primary cardiovascular prevention compared to a MedDiet alone. Participants answered a 36-item questionnaire about health-related quality of life (HRQoL) and a 17-item questionnaire that assessed adherence to an MedDiet. We used ANCOVA and multivariable-adjusted linear regression models to compare baseline adjusted means of the quality of life scales according to categories of adherence to the MedDiet. Higher adherence to the MedDiet was independently associated with significantly better scores in the eight dimensions of HRQoL. Adjusted differences of > = 3 points between the highest and the lowest dietary adherence groups to the MedDiet were observed for vitality, emotional role, and mental health and of > = 2 points for the other dimensions. In conclusion, this study shows a positive association between adherence to a MedDiet and several dimensions of quality of life. [ABSTRACT FROM AUTHOR]

Rationale and Objective: The Mediterranean diet (MeDiet) has beneficial effects on cardiovascular risk factors. We analyzed the association between adherence of a MeDiet in patients with type 2 diabetes mellitus (T2DM) and levels of HbA1c. Patients and Methods: This was a cross-sectional study in individuals with T2DM participating in the PREDIMED trial at the centre of Pamplona. Information on diet was collected with a validated 14 point scale of adherence to the MeDiet and blood samples were obtained to assess HbA1c levels. Results: We studied 383 participants with T2DM, 53.4% women (mean age 69 ± 6 years). HbA1c data were available in 262 cases (mean 6.9 ± 1.5%). Although there was a potential inverse non-significant association between adherence to MeDiet and HbA1c levels after adjusting for age and sex, it was not statistically significant. Multivariate analysis additionally adjusted for physical activity, smoking, time of evolution of the T2DM, body mass index and insulin treatment found similar findings (OR = 0.69, 95% CI 0.17-2.83). Conclusions: Although we found not enough evidence to support that a MeDiet is associated with lower levels of HbA1c in patients with T2DM, our results suggested an inverse trend. Future studies with larger sample size are necessary. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Abstract: Background: Intima-media thickness (IMT) is a valid marker for generalized vascular disease whose main risk factors are associated with food habits and lifestyle. A Mediterranean food pattern may have a protective effect on cardiovascular mortality. Objective: To assess the relationship between carotid IMT and olive oil consumption. Methods: One hundred and ninety nine patients were randomly extracted from 1055 asymptomatic high cardiovascular risk participants at the AP-UNAV recruitment center of the PREDIMED (PREvención con DIeta MEDiterránea) project. Demographic and clinical variables were collected, and a validated semiquantitative food frequency questionnaire (137 items) was administered at the inclusion interview. A B-mode ultrasound imaging technique was used to measure the mean common carotid IMT. Results: The mean age was 67.3 years and 53.3% were women. Energy-adjusted olive oil consumption quintiles were assessed as the main exposure after adjusting for potential dietary and non-dietary confounders. Using continuous carotid IMT as the outcome in an ANCOVA analysis, the adjusted IMT means throughout quintiles showed an inverse association with a plateau after the second quintile, with statistical differences when the adjusted IMT mean of the merged four upper quintiles were compared with the lowest quintile (p <0.05). The averaged (both sides) mean IMT of the common carotid was dichotomised and values above the median (0.804mm) were used to identify carotid atherosclerotic damage. We also found an inverse association of olive oil consumption with high IMT, throughout the second to the fifth quintile as compared with the lowest quintile. The adjusted OR was of 0.08 (95% confidence interval, CI, of 0.02–0.37; p =0.001) after merging the four upper quintiles. Conclusion: The inverse association between the olive oil consumption and the carotid IMT could suggest a protective role of olive oil against the development of carotid atherosclerosis in persons at high cardiovascular risk. [Copyright &y& Elsevier]

Background Cognitive decline, a common process of brain ageing, has been associated with telomere length (TL). Delving into the identification of reliable biomarkers of brain ageing is essential to prevent accelerated cognitive impairment. Methods We selected 317 non-smoking 'Prevención con Dieta Mediterránea-Plus' (PREDIMED-Plus) participants (mean age, 65.8 ± 5.0 years) with metabolic syndrome from two trial centres who were following a lifestyle intervention. We measured TL and cognitive function at baseline and after 3 and 4 years of follow-up, respectively. Associations between baseline or 3-year changes in TL and baseline or 4-year changes in cognitive function were analysed using multivariable regression models. Results Baseline TL was not associated with baseline cognitive performance. Nevertheless, longer baseline TL was associated with improved 4-year changes in the Executive Function domain (β: 0.29; 95%CI: 0.12 to 0.44; P < 0.001) and the Global Cognitive Function domain (β: 0.19; 95%CI: 0.05 to 0.34; P = 0.010). Besides, a positive association was found between longer baseline TL and improved 4-year changes in the animal version of the Verbal Fluency Test (β: 0.33; 95%CI: 0.12 to 0.52; P =  0.002). By contrast, 3-year changes in TL were not associated with changes in cognitive function after 4 years. Conclusions Longer baseline TL could protect from cognitive decline and be used as a useful biomarker of brain ageing function in an older Mediterranean population at risk of cardiovascular disease and cognitive impairment. [ABSTRACT FROM AUTHOR]

Purpose: Long-term nutrition trials may fail to respond to their original hypotheses if participants do not comply with the intended dietary intervention. We aimed to identify baseline factors associated with successful dietary changes towards an energy-reduced Mediterranean diet (MedDiet) in the PREDIMED-Plus randomized trial. Methods: Longitudinal analysis of 2985 participants (Spanish overweight/obese older adults with metabolic syndrome) randomized to the active intervention arm of the PREDIMED-Plus trial. Dietary changes were assessed with a 17-item energy-reduced MedDiet questionnaire after 6 and 12 months of follow-up. Successful compliance was defined as dietary changes from baseline of ≥ 5 points for participants with baseline scores < 13 points or any increase if baseline score was ≥ 13 points. We conducted crude and adjusted multivariable logistic regression models to identify baseline factors related to compliance. Results: Consistent factors independently associated with successful dietary change at both 6 and 12 months were high baseline perceived self-efficacy in modifying diet (OR6-month: 1.51, 95% CI 1.25–1.83; OR12-month: 1.66, 95% CI 1.37–2.01), higher baseline fiber intake (OR6-month: 1.62, 95% CI 1.07–2.46; OR12-month: 1.62, 95% CI 1.07–2.45), having > 3 chronic conditions (OR6-month: 0.65, 95% CI 0.53–0.79; OR12-month: 0.76, 95% CI 0.62–0.93), and suffering depression (OR6-month: 0.80, 95% CI 0.64–0.99; OR12-month: 0.71, 95% CI 0.57–0.88). Conclusion: Our results suggested that recruitment of individuals with high perceived self-efficacy to dietary change, and those who initially follow diets relatively richer in fiber may lead to greater changes in nutritional recommendations. Participants with multiple chronic conditions, specifically depression, should receive specific tailored interventions. Trial registration: ISRCTN registry 89898870, 24th July 2014 retrospectively registered http://www.isrctn.com/ISRCTN89898870. [ABSTRACT FROM AUTHOR]

Purpose: This study aims to identify gender disparities in knowledge, attitudes and behaviors related to self-management and control of Type 2 diabetes Mellitus (T2DM) among primary care patients. The research was conducted across multiple Spanish cities. Patients and Methods: The study involved 8 Primary Care Centres located in four distinct regions of Spain: East (Barcelona), Centre (Madrid), North (Pamplona and Zumaia) and South (Vélez-Málaga and Málaga). A total of 111 individuals diagnosed with T2DM, comprising 52 women and 59 men, participated in 12 group discussions at these primary healthcare centers from February to June 2015. Participation was voluntary, and all participants provided informed consent by signing the consent form. A qualitative hermeneutic phenomenological study with a maximum variation sample was done. Participant profiles were defined based on gender, age, place of residence, type of treatment, years living with T2DM and the presence or absence of a cardiovascular event. Thematic analysis was used to analyze the data. Results: Participants were aware that diabetes is a chronic condition, with varied levels of concern regarding the diagnosis. Participants' locus of control influenced their perception of the disease's cause, with women attributing it to stress and emotional situations, while men linked it to risky behaviors. Self-management strategies were shaped by beliefs about diabetes, with both genders facing challenges in implementing recommended practices. Gender differences were also evident in caregiving roles, with men receiving more family support for diet adherence, while women prioritized family needs over their self-care. Participants expressed satisfaction with professional-patient interactions but highlighted the need for more accessible information and specialist care, suggesting support groups for women and clear health guidelines for men. Conclusion: Gender differences significantly influence how patients perceive and manage type 2 diabetes, with women experiencing greater concern and care burden compared to men. Effective diabetes management requires tailored support that addresses these gender-specific challenges. Enhancing healthcare services with clear guidelines and support groups can improve self-management outcomes in both men and women. [ABSTRACT FROM AUTHOR]

Objectives To evaluate how glycemic index ( GI) and glycemic load ( GL) are associated with the metabolic syndrome (MetS) and its features in middle-aged and elderly adults at high cardiovascular risk. Design Prospective, longitudinal, population-based cohort. Setting PREvención con DIeta MEDiterránea study. Participants Men and women (N = 6,606) divided into three age groups (<65, 65-74, ≥75). Measurements Energy and nutrient intake was evaluated using a validated 137-item food frequency questionnaire. MetS and its features were defined in accordance with the criteria of the American Heart Association and National Heart, Lung, and Blood Institute. Results A positive association was observed between GI and MetS prevalence in the youngest and middle age groups for participants without diabetes mellitus, but no relationship was found for those with diabetes mellitus. During the median follow-up of 4.8 years, higher GI and GL were related to greater risk of MetS in the middle age group, independent of the presence of diabetes mellitus. Changes in dietary GI were associated with risk of developing the high fasting glucose component of the MetS in the oldest age category, and changes in dietary GL were associated with risk of developing abdominal obesity, hypertriglyceridemia, low high-density lipoprotein cholesterol, and high blood pressure in the youngest age category. Conclusion Dietary GI and GL have a potential role in the development of MetS and associated clinical features, with particular age-dependent considerations. [ABSTRACT FROM AUTHOR]

Background: The optimal distribution between physical activity (PA) levels and sedentary behaviour (SB) for the greatest benefits for body composition among older adults with overweight/obesity and chronic health conditions remains unclear. We aimed to determine the prospective association between changes in PA and in SB with concurrent changes in body composition and to examine whether reallocating inactive time into different physical activity levels was associated with 12-month change to body composition in older adults.Methods: Longitudinal assessment nested in the PREDIMED-Plus trial. A subsample (n = 1564) of men and women (age 55-75 years) with overweight/obesity and metabolic syndrome from both arms of the PREDIMED-Plus trial was included in the present analysis. Participants were followed up at 6 and 12 months. Physical activity and SB were assessed using validated questionnaires. Out of 1564 participants, 388 wore an accelerometer to objectively measure inactive time and PA over a 7-day period. At each time point, participants' body composition was measured using dual-energy X-ray absorptiometry (DXA). Standard covariate-adjusted and isotemporal substitution modelling were applied to linear mixed-effects models.Results: Increasing 30 min of total PA and moderate-to-vigorous physical activity (MVPA) was associated with significant reductions in body fat (β - 0.07% and - 0.08%) and visceral adipose tissue (VAT) (- 13.9 g, and - 15.6 g) at 12 months (all p values < 0.001). Reallocating 30 min of inactive time to MVPA was associated with reductions in body fat and VAT and with an increase in muscle mass and muscle-to-fat mass ratio (all p values < 0.001).Conclusions: At 12 months, increasing total PA and MVPA and reducing total SB and TV-viewing SB were associated with improved body composition in participants with overweight or obesity, and metabolic syndrome. This was also observed when substituting 30 min of inactive time with total PA, LPA and MVPA, with the greatest benefits observed with MVPA.Trial Registration: International Standard Randomized Controlled Trial (ISRCTN), 89898870 . Retrospectively registered on 24 July 2014. [ABSTRACT FROM AUTHOR]

Purpose: Cardiovascular disease remains the global leading cause of death. We evaluated at baseline the association between the adherence to eight a priori high-quality dietary scores and the prevalence of individual and clustered cardiovascular risk factors (CVRF) in the PREDIMED-Plus cohort. Methods: All PREDIMED-Plus participants (6874 men and women aged 55–75 years, with overweight/obesity and metabolic syndrome) were assessed. The prevalence of 4 CVRF (hypertension, obesity, diabetes, and dyslipidaemia), using standard diagnoses criteria, were considered as outcomes. The adherence to eight a priori-defined dietary indexes was calculated. Multivariable models were fitted to estimate differences in mean values of factors and prevalence ratios for individual and clustered CVRF. Results: Highest conformity to any dietary pattern did not show inverse associations with hypertension. The modified Mediterranean Diet Score (PR = 0.95; 95% CI 0.90–0.99), Mediterranean Diet Adherence Score (MEDAS) (PR = 0.94; 95% CI 0.89–0.98), the pro-vegetarian dietary pattern (PR = 0.95; 95% CI 0.90–0.99) and the Alternate Healthy Eating Index 2010 (PR = 0.92; 95% CI 0.87–0.96) were inversely associated with prevalence of obesity. We identified significant inverse trend among participants who better adhered to the MEDAS and the Prime Diet Quality Score (PDQS) in the mean number of CVRF across categories of adherence. Better adherence to several high-quality dietary indexes was associated with better blood lipid profiles and anthropometric measures. Conclusions: Highest adherence to dietary quality indexes, especially Mediterranean-style and PDQS scores, showed marginal associations with lower prevalence of individual and clustered CVRF among elderly adults with metabolic syndrome at high risk of cardiovascular disease [ABSTRACT FROM AUTHOR]

Background: Visceral adipose tissue (VAT) is a strong predictor of cardiometabolic health, and lifestyle factors may have a positive influence on VAT depot. This study aimed to assess the cross-sectional associations between baseline levels of physical activity (PA), sedentary behaviours (SB) and adherence to the Mediterranean diet (MedDiet) with VAT depot in older individuals with overweight/obesity and metabolic syndrome. Methods: Baseline data of the PREDIMED-Plus study including a sample of 1,231 Caucasian men and women aged 55–75 years were used. Levels of leisure-time PA (total, light, and moderate-to-vigorous, in METs·min/day) and SB (total and TV-viewing, in h/day) were evaluated using validated questionnaires. Adherence to the MedDiet was evaluated using a 17-item energy-restricted MedDiet (erMedDiet) screener. The chair-stand test was used to estimate the muscle strength. VAT depot was assessed with DXA-CoreScan. Multivariable adjusted linear regression models were used to evaluate the association between lifestyle factors and VAT. For the statistics we had used multiadjusted linear regression models. Results: Total leisure-time PA (100 METs·min/day: β -24.3g, -36.7;-11.9g), moderate-to-vigorous PA (β -27.8g, 95% CI -40.8;-14.8g), chair-stand test (repeat: β -11.5g, 95% CI -20.1;-2.93g) were inversely associated, and total SB (h/day: β 38.2g, 95% CI 14.7;61.7) positively associated with VAT. Light PA, TV-viewing time and adherence to an erMedDiet were not significantly associated with VAT. Conclusions: In older adults with overweigh/obesity and metabolic syndrome, greater PA, muscle strength, and lower total SB were associated with less VAT depot. In this study, adherence to an erMedDiet was not associated with lower VAT. [ABSTRACT FROM AUTHOR]

Background The study of the plasma lipidome may help to better characterize molecular mechanisms underlying cardiovascular disease. The identification of new lipid biomarkers could provide future targets for prevention and innovative therapeutic approaches. In the frame of the PREDIMED trial, our aim was to examine the associations of baseline lipidome patterns or their changes with the risk of clinical CVD events. Methods We included 983 participants in our case-cohort study. The end-point was the incidence of major CVD during 4.8 years of median follow-up. We repeatedly measured 202 plasma known lipid metabolites at baseline and after 1-year of intervention. Principal component analysis was used to identify lipidome factors. Among the 15 identified factors, 7 were significantly associated with CVD. Considering common patterns among factors, lipids were grouped (summed) into scores. Results After adjustment for traditional CVD risk factors, scores of baseline polyunsaturated phosphatidylcholines (PC)/lysoPC/PC-plasmalogens and polyunsaturated cholesterol esters (CE) showed inverse associations with CVD (p = 0.036 and 0.012, respectively); whereas scores of monoacylglycerols (MAGs)/diacylglycerols (DAGs) and short triacylglycerols (TAGs) showed a direct association with CVD (p = 0.026 and 0.037, respectively). Baseline phosphatidylethanolamines (PEs) and their 1-y changes tended to be associated with higher CVD risk (p = 0.066 and 0.081, respectively). We did not find a significant effect of the intervention with the Mediterranean Diet on these scores. Conclusions Our study suggests that polyunsaturated PCs and CEs may confer protection against CVD. In contrast, MAGs, DAGs, TAGs and PEs appeared to be associated with higher CVD risk. [ABSTRACT FROM AUTHOR]

The association of dietary energy density (ED) and overweight is not clear in the literature. Our aim was to study in 4259 of the PREDIMED trial whether an increase in dietary ED based on a higher adherence to a Mediterranean dietary pattern was associated with 3-year weight gain. A validated 137-item food-frequency questionnaire was administered. Multivariable-adjusted models were used to analyze the association between 3-year ED change and the subsequent 3-year body weight change. The most important weight reduction after 3-year follow-up was observed in the two lowest quintiles and the highest quintile of ED change. The highest ED increase was characterized by an increased intake of extra virgin olive oil (EVOO) and nuts and a decreased intake of other oils, vegetable and fruit consumption (p < .001). In conclusion, increased 3-year ED in the PREDIMED study, associated with a higher EVOO and nuts consumption, was not associated with weight gain. [ABSTRACT FROM PUBLISHER]

Purpose: The possible effects of dairy consumption on diabetes prevention remain controversial. The aim of this study was to investigate the association between the dairy consumption and type 2 diabetes (T2D) risk in an elderly Mediterranean population at high cardiovascular risk. Methods: We prospectively followed 3,454 non-diabetic individuals from the PREDIMED study. Dairy consumption was assessed at baseline and yearly using food frequency questionnaires and categorized into total, low-fat, whole-fat, and subgroups: milk, yogurt, cheeses, fermented dairy, concentrated full fat, and processed dairy. Hazard ratios (HRs) were calculated using Cox proportional hazards regression models. Results: During a median follow-up of 4.1 years, we documented 270 incident T2D cases. After multivariate adjustment, total dairy product consumption was inversely associated with T2D risk [0.68 (95 % CI 0.47-0.98); P-trend = .040]. This association appeared to be mainly attributed to low-fat dairy; the multivariate HRs (95 % CIs) comparing the highest versus the lowest tertile consumption were 0.65 (0.45-0.94) for low-fat dairy products and 0.67 (0.46-0.95) for low-fat milk (both P-trend <.05). Total yogurt consumption was associated with a lower T2D risk [HR 0.60 (0.42-0.86); P-trend = .002]. An increased consumption of total low-fat dairy and total yogurt during the follow-up was inversely associated with T2D; HRs were 0.50 (0.29-0.85), 0.44 (0.26-0.75), and 0.55 (0.33-0.93), respectively. Substituting one serving/day of a combination of biscuits and chocolate and whole grain biscuits and homemade pastries for one serving/day of yogurt was associated with a 40 and 45 % lower risk of T2D, respectively. No significant associations were found for the other dairy subgroups (cheese, concentrated full fat, and processed dairy products). Conclusions: A healthy dietary pattern incorporating a high consumption of dairy products and particularly yogurt may be protective against T2D in older adults at high cardiovascular risk. [ABSTRACT FROM AUTHOR]

Background: increased carotid íntima-media thickness (IMT) is a marker of atherosclerosis and a predictor of future cardiovascular events. Although a beneficial effect of Mediterranean diets, in particular, enhanced with virgin olive oil and nuts, on longitudinal changes in IMT has been reported, the association between carbohydrates and the development of atherosclerosis is still unclear.Objective: to assess the association between glycemic index (IG) and glycemic load (CG) of the diet and intima media thickness (GIMC) in a population at high cardiovascular risk with no clinical symptoms.Methods: one hundred eighty seven participants of the PREDIMED-NAVARRA center (PREDIMED means in Spanish "PREvención con DIeta MEDiterránea") were randomly selected to undergo baseline and 1-year measurement of GIMC. Dietary information was collected at baseline and yearly using a validated 137-item food frequency questionnaire. Participants were categorized into four groups of energy-adjusted IG and CG intake. Multivariate analysis models (ANCOVA) were used to study the association between dietary IG and CG and GIMC and its changes.Results: in our study we found no significant association between IG or CG and GIMC at baseline or after one year. [ABSTRACT FROM AUTHOR]

Objective: Understanding patients' and physicians' perceptions of type 2 diabetes mellitus (T2DM) management and treatment has important implications for diabetes care, allowing the identification of clinical practice issues that could be improved, leading to patients' better understanding of the illness and, consequently, healthier self-management behaviors. The objective of this study was to identify differences between physicians' and T2DM patients' perceptions related to health status, patient-reported outcomes assessments, and T2DM management and treatment, in routine clinical practice in Spain. Methods: This was an observational, cross-sectional study including 1,012 T2DM patients and 974 physicians from 47 and 52 Spanish provinces, respectively. An electronic structured self-administered questionnaire containing 17 questions was designed aiming to address both physicians' and patient's perceptions on overall T2DM health status and patient-reported outcomes. Results: T2DM patients perceived a worse health status (40% reported having a "good" and 38% a "neither good nor bad" health status) compared with physicians' perceptions (77% thought patients had a "good" health status). Most patients answered being "satisfied" or "neither satisfied nor unsatisfied" with the given information, while physicians considered that patients were "satisfied" or "very satisfied" with the information for self-monitoring blood glucose and treatment administration. Fifty-seven percent of patients reported that medical recommendations were "important", while 58% of physicians considered it as "very important". Fifty-three percent of patients perceived that their current T2DM treatment suited their preferences "quite a lot", and this was lower than the proportion of physicians (69%) that believed this for their patients. Additionally, a lower percentage of patients (53%) than physicians (79%) believed that their treatment improved their health-related quality of life "quite a lot". All differences between patients and physicians were statistically significant (P,0.001). Conclusion: Patients and physicians demonstrate different views concerning all questions related to T2DM health status and diabetes management and treatment (information, recommendations, satisfaction, and preferences). [ABSTRACT FROM AUTHOR]

Objective: Different types of carbohydrates have diverse glycemic response, thus glycemic index (GI) and glycemic load (GL) are used to assess this variation. The impact of dietary GI and GL in all-cause mortality is unknown. The objective of this study was to estimate the association between dietary GI and GL and risk of all-cause mortality in the PREDIMED study. Material and Methods: The PREDIMED study is a randomized nutritional intervention trial for primary cardiovascular prevention based on community-dwelling men and women at high risk of cardiovascular disease. Dietary information was collected at baseline and yearly using a validated 137-item food frequency questionnaire (FFQ). We assigned GI values of each item by a 5-step methodology, using the International Tables of GI and GL Values. Deaths were ascertained through contact with families and general practitioners, review of medical records and consultation of the National Death Index. Cox regression models were used to estimate multivariable-adjusted hazard ratios (HR) and their 95% CI for mortality, according to quartiles of energy-adjusted dietary GI/GL. To assess repeated measures of exposure, we updated GI and GL intakes from the yearly FFQs and used Cox models with time-dependent exposures. Results: We followed 3,583 non-diabetic subjects (4.7 years of follow-up, 123 deaths). As compared to participants in the lowest quartile of baseline dietary GI, those in the highest quartile showed an increased risk of all-cause mortality [HR = 2.15 (95% CI: 1.15–4.04); P for trend  = 0.012]. In the repeated-measures analyses using as exposure the yearly updated information on GI, we observed a similar association. Dietary GL was associated with all-cause mortality only when subjects were younger than 75 years. Conclusions: High dietary GI was positively associated with all-cause mortality in elderly population at high cardiovascular risk. [ABSTRACT FROM AUTHOR]

BACKGROUND: The PREDIMED (Prevención con Dieta Mediterránea) randomized primary prevention trial showed that a Mediterranean diet enriched with either extravirgin olive oil or mixed nuts reduces the incidence of stroke, myocardial infarction, and cardiovascular mortality. We assessed the effect of these diets on the incidence of atrial fibrillation in the PREDIMED trial. METHODS AND RESULTS: Participants were randomly assigned to 1 of 3 diets: Mediterranean diet supplemented with extravirgin olive oil, Mediterranean diet supplemented with mixed nuts, or advice to follow a low-fat diet (control group). Incident atrial fibrillation was adjudicated during follow-up by an events committee blinded to dietary group allocation. Among 6705 participants without prevalent atrial fibrillation at randomization, we observed 72 new cases of atrial fibrillation in the Mediterranean diet with extravirgin olive oil group, 82 in the Mediterranean diet with mixed nuts group, and 92 in the control group after median follow-up of 4.7 years. The Mediterranean diet with extravirgin olive oil significantly reduced the risk of atrial fibrillation (hazard ratio, 0.62; 95% confidence interval, 0.45-0.85 compared with the control group). No effect was found for the Mediterranean diet with nuts (hazard ratio, 0.89; 95% confidence interval, 0.65-1.20). CONCLUSIONS: In the absence of proven interventions for the primary prevention of atrial fibrillation, this post hoc analysis of the PREDIMED trial suggests that extravirgin olive oil in the context of a Mediterranean dietary pattern may reduce the risk of atrial fibrillation. CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Unique identifier: ISRCTN35739639. [ABSTRACT FROM AUTHOR]

Background--The PREDIMED (Prevención con Dieta Mediterránea) randomized primary prevention trial showed that a Mediterranean diet enriched with either extravirgin olive oil or mixed nuts reduces the incidence of stroke, myocardial infarction, and cardiovascular mortality. We assessed the effect of these diets on the incidence of atrial fibrillation in the PREDIMED trial. Methods and Results--Participants were randomly assigned to 1 of 3 diets: Mediterranean diet supplemented with extravirgin olive oil, Mediterranean diet supplemented with mixed nuts, or advice to follow a low-fat diet (control group). Incident atrial fibrillation was adjudicated during follow-up by an events committee blinded to dietary group allocation. Among 6705 participants without prevalent atrial fibrillation at randomization, we observed 72 new cases of atrial fibrillation in the Mediterranean diet with extravirgin olive oil group, 82 in the Mediterranean diet with mixed nuts group, and 92 in the control group after median follow-up of 4.7 years. The Mediterranean diet with extravirgin olive oil significantly reduced the risk of atrial fibrillation (hazard ratio, 0.62; 95% confidence interval, 0.45-0.85 compared with the control group). No effect was found for the Mediterranean diet with nuts (hazard ratio, 0.89; 95% confidence interval, 0.65-1.20). Conclusions--In the absence of proven interventions for the primary prevention of atrial fibrillation, this post hoc analysis of the PREDIMED trial suggests that extravirgin olive oil in the context of a Mediterranean dietary pattern may reduce the risk of atrial fibrillation. Clinical Trial Registration--URL: http://www.controlled-trials.com. Unique identifier: ISRCTN35739639. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. Methods: The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for cardiovascular disease. Participants were assigned to a control group or to one of two Mediterranean diets. The control group received education on following a low-fat diet, while the groups on Mediterranean diets received nutritional education and also free foods; either extra virgin olive oil, or nuts. Trained personnel measured participants' BP at baseline and once yearly during a 4-year follow-up. We used generalized estimating equations to assess the differences between groups during the follow-up. Results: The percentage of participants with controlled BP increased in all three intervention groups (P-value for within-group changes: P<0.001). Participants allocated to either of the two Mediterranean diet groups had significantly lower diastolic BP than the participants in the control group (-1.53 mmHg (95% confidence interval (CI) -2.01 to -1.04) for the Mediterranean diet supplemented with extra virgin olive oil, and -0.65 mmHg (95% CI -1.15 to -0.15) mmHg for the Mediterranean diet supplemented with nuts). No between-group differences in changes of systolic BP were seen. Conclusions: Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP. However, we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group. [ABSTRACT FROM AUTHOR]

Background: Alcoholic beverages are widely consumed. Depression, the most prevalent mental disorder worldwide, has been related to alcohol intake. We aimed to prospectively assess the association between alcohol intake and incident depression using repeated measurements of alcohol intake.Methods: We followed-up 5,505 high-risk men and women (55 to 80 y) of the PREDIMED Trial for up to seven years. Participants were initially free of depression or a history of depression, and did not have any history of alcohol-related problems. A 137-item validated food frequency questionnaire administered by a dietician was repeated annually to assess alcohol intake. Participants were classified as incident cases of depression when they reported a new clinical diagnosis of depression, and/or initiated the use of antidepressant drugs. Cox regression analyses were fitted over 23,655 person-years.Results: Moderate alcohol intake within the range of 5 to 15 g/day was significantly associated with lower risk of incident depression (hazard ratio (HR) and 95% confidence interval (95% CI) = 0.72 (0.53 to 0.98) versus abstainers). Specifically, wine consumption in the range of two to seven drinks/week was significantly associated with lower rates of depression (HR (95% CI) = 0.68 (0.47 to 0.98)).Conclusions: Moderate consumption of wine may reduce the incidence of depression, while heavy drinkers seem to be at higher risk. [ABSTRACT FROM AUTHOR]

Objective: Independently of total caloric intake, a better quality of the diet (for example, conformity to the Mediterranean diet) is associated with lower obesity risk. It is unclear whether a brief dietary assessment tool, instead of full-length comprehensive methods, can also capture this association. In addition to reduced costs, a brief tool has the interesting advantage of allowing immediate feedback to participants in interventional studies. Another relevant question is which individual items of such a brief tool are responsible for this association. We examined these associations using a 14-item tool of adherence to the Mediterranean diet as exposure and body mass index, waist circumference and waist-to-height ratio (WHtR) as outcomes. Design: Cross- sectional assessment of all participants in the "PREvención con DIeta MEDiterranea" (PREDIMED) trial. Subjects: 7,447 participants (55-80 years, 57% women) free of cardiovascular disease, but with either type 2 diabetes or $3 cardiovascular risk factors. Trained dietitians used both a validated 14-item questionnaire and a full-length validated 137-item food frequency questionnaire to assess dietary habits. Trained nurses measured weight, height and waist circumference. Results: Strong inverse linear associations between the 14-item tool and all adiposity indexes were found. For a two-point increment in the 14- item score, the multivariable-adjusted differences in WHtR were 20.0066 (95% confidence interval, 0.0088 to 20.0049) for women and -0.0059 (-0.0079 to - 0.0038) for men. The multivariable-adjusted odds ratio for a WHtR>0.6 in participants scoring ≥10 points versus ≤7 points was 0.68 (0.57 to 0.80) for women and 0.66 (0.54 to 0.80) for men. High consumption of nuts and low consumption of sweetened/carbonated beverages presented the strongest inverse associations with abdominal obesity. Conclusions: A brief 14-item tool was able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults at high cardiovascular risk. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Observational studies have reported inverse associations between adherence to the Mediterranean diet (MedDiet) and atherosclerotic disease. We tested the effect of two types of MedDiet on progression of subclinical carotid atherosclerosis. Methods: We randomized 187 high-cardiovascular-risk asymptomatic subjects (51% women, mean age 67 years) to three treatment arms: MedDiet with supplemental virgin olive oil (VOO), n =66; MedDiet with supplemental nuts, n =59; and control diet, n =62. Participants received nutrition behavioral counseling in quarterly group and individual educational sessions. Free supplemental foods were provided to the MedDiet groups. Changes in mean intima-media thickness (IMT) were measured ultrasonographically in the far wall of bilateral common carotid arteries after 1 year. Results: Overall, no significant between-group differences in IMT progression were observed after 1-year. However, a significant interaction (p =0.03) between baseline IMT and treatment effect was apparent. Among participants with baseline IMT≥0.9mm, 1-year IMT changes versus control showed significant differences of −0.079mm (95% confidence interval, −0.145 to −0.012) for the MedDiet with VOO and −0.072mm (−0.140 to −0.004) for the MedDiet with nuts. No IMT changes occurred in any intervention group among participants with lower baseline IMT values (<0.9mm). Conclusions: MedDiets enhanced with VOO or nuts were not effective in inducing ultrasonographic regression of carotid atherosclerosis after 1 year intervention. However, they were effective among subjects with elevated baseline IMT, suggesting that subclinical atherosclerosis may respond to dietary intervention within a relatively short time frame only among subjects with a high initial atherosclerotic burden. [Copyright &y& Elsevier]

Objectives There are no human studies assessing the effect of nutritional interventions on plasma brain-derived neurotrophic factor (BDNF) concentrations. The aim of this study was to assess the role of a nutritional intervention based on a Mediterranean diet (MeDiet) on plasma BDNF levels. Methods PREvención con Dieta MEDiterránea (PREDIMED) is a randomized clinical trial designed to assess the effect of a Mediterranean diet (MeDiet) on the primary prevention of cardiovascular disease. For this analysis, 243 participants from the Navarra centre were randomly selected. Participants were assigned to one of three dietary interventions: control (low-fat) diet, MeDiet supplemented with virgin olive oil (MeDiet + VOO), or MeDiet supplemented with nuts (MeDiet + Nuts). Plasma BDNF levels were measured after 3 years of intervention. Multivariate-adjusted means of BDNF for each intervention were compared using generalized linear models. Logistic regression models were fit to assess the association between the dietary intervention and the likelihood to have low plasma BDNF values (<13 µg/ml, 10th percentile). Analyses were repeated after stratifying the sample according to baseline prevalence of different diseases. Results Higher but non-significant plasma BDNF levels were observed for participants assigned to both MeDiets. Participants assigned to MeDiet + Nuts showed a significant lower risk (odds ratios (OR) = 0.22; 95% confidence intervals (CI) = 0.05-0.90) of low plasma BDNF values (<13 µg/ml) as compared to the control group. Among participants with prevalent depression at baseline, significantly higher BDNF levels were found for those assigned to the MeDiet + Nuts. Discussion Adherence to a MeDiet was associated to an improvement in plasma BDNF concentrations in individuals with depression. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: Apolipoprotein (Apo)B, ApoA-I, and their ratio could predict coronary heart disease (CHD) risk more accurately than conventional lipid measurements. Our aim was to assess the effect of a traditional Mediterranean diet (TMD) on apolipoproteins. Methods: High-cardiovascular risk subjects (n =551, 308 women and 243 men), aged 55–80 years, were recruited into a large, multicenter, randomized, controlled, parallel-group, clinical trial (The PREDIMED Study) aimed at testing the efficacy of TMD on primary cardiovascular disease prevention. Participants assigned to a low-fat diet (control) (n =177), or TMDs (TMD+virgin olive oil (VOO), n =181 or TMD+nuts, n =193) received nutritional education and either free VOO (ad libitum) or nuts (dose: 30g/day). A 3-month evaluation was performed. Results: Both TMDs promoted beneficial changes on classical cardiovascular risk factors. ApoA-I increased, and ApoB and ApoB/ApoA-I ratio decreased after TMD+VOO, the changes promoting a lower cardiometabolic risk. Changes in TMD+VOO versus low-fat diet were −2.9mg/dL (95% CI, −5.6 to −0.08), 3.3mg/dL (95% CI, 0.84 to 5.8), and −0.03mg/dL (−0.05 to −0.01) for ApoB, ApoA-I, and ApoB/ApoA-I ratio, respectively. Conclusions: Individuals at high-cardiovascular risk who improved their diet toward a TMD pattern rich in virgin olive oil, reduced their Apo B and ApoB/ApoA-I ratio and improved ApoA-I concentrations. [Copyright &y& Elsevier]

Background: The effect of macronutrient intake on the metabolic syndrome (MS) is still controversial. Our aim in this study was to assess the relationships between macronutrient intake and the risk of developing the MS in subjects at high cardiovascular risk. Methods: In this cross-sectional study, 967 high-risk men and women (55–80 years) were assessed according to the MS criteria defined by the National Cholesterol Education Program Adult Treatment Panel III (ATP3) and those established by the International Diabetes Federation (IDF). A 137-item validated food frequency questionnaire was used. Odds ratios (OR) for macronutrient intake and MS were calculated and adjustments were made for potential confounders. Results: When applying the ATP3 criteria, an inverse association was found for fiber and polyunsaturated fatty acid (PUFAs) intake, with ORs of 0.55 (95% CI: 0.35–0.86) and 0.60 (95% CI: 0.39–0.94), respectively, for the 5th versus the 1st quintile. Using the IDF criteria, an inverse association between fiber intake and the MS was obtained whereas a direct association was found between carbohydrate intake and the MS: OR = 1.71 (95% CI: 1.05–2.79) for the highest versus the lowest quintile. Conclusions: A diet rich in fiber and PUFAs is correlated with a reduced risk of MS in subjects at high cardiovascular risk. Copyright © 2010 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

A response from the authors of the article "Extravirgin Olive Oil Consumption Reduces Risk of Atrial Fibrillation: The PREDIMED (Prevención con Dieta Mediterránea) Trial" is presented.

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. [ABSTRACT FROM AUTHOR]

Background: Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern.Methods: The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for cardiovascular disease. Participants were assigned to a control group or to one of two Mediterranean diets. The control group received education on following a low-fat diet, while the groups on Mediterranean diets received nutritional education and also free foods; either extra virgin olive oil, or nuts. Trained personnel measured participants' BP at baseline and once yearly during a 4-year follow-up. We used generalized estimating equations to assess the differences between groups during the follow-up.Results: The percentage of participants with controlled BP increased in all three intervention groups (P-value for within-group changes: P<0.001). Participants allocated to either of the two Mediterranean diet groups had significantly lower diastolic BP than the participants in the control group (-1.53 mmHg (95% confidence interval (CI) -2.01 to -1.04) for the Mediterranean diet supplemented with extra virgin olive oil, and -0.65 mmHg (95% CI -1.15 to -0.15) mmHg for the Mediterranean diet supplemented with nuts). No between-group differences in changes of systolic BP were seen.Conclusions: Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP. However, we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group.Trial Registration: Current Controlled Trials ISRCTN35739639. [ABSTRACT FROM AUTHOR]