Gomez-Gracia, E. (Enrique)
- Publications
- item.page.relationships.isContributorAdvisorOfPublication
- item.page.relationships.isContributorOfPublication
45 results
Search Results
Now showing 1 - 10 of 45
- The Effect of a Mediterranean Diet on the Incidence of Cataract Surgery(2017) Martinez-Gonzalez, M.A. (Miguel Ángel); Fiol, M. (Miquel); Fito, M. (Montserrat); Gomez-Gracia, E. (Enrique); Sala-Vila, A. (Aleix); Toledo, E. (Estefanía); Lapetra, J. (José); Ciufo, G. (Gianfranco); Garcia-Layana, A. (Alfredo); Vinyoles, E. (Ernest); Ros, E. (Emilio); Bullo, M. (Monica); Portillo, M.P. (María P.); Estruch, R. (Ramón); Serra-Majem, L. (Luis); Corella, D. (Dolores); Pinto, X. (Xavier); Salas-Salvado, J. (Jordi); Sorli, J.V. (Jose V.); Aros, F. (Fernando)Background: Cataract is a leading cause of vision impairment worldwide, and surgery is the only available treatment. The process that initiates lens opacification is dependent on the oxidative stress experienced by the lens components. A healthy overall dietary pattern, with the potential to reduce oxidative stress, has been suggested as a means to decrease the risk of developing cataract. We aimed to investigate the hypothesis that an intervention with a Mediterranean diet (MedDiet) rather than a low-fat diet could decrease the incidence of cataract surgery in elderly subjects. Methods: We included 5802 men and women (age range: 55–80 years) from the Prevención con Dieta Mediterránea study (multicenter, parallel-group, randomized controlled clinical trial) who had not undergone cataract surgery. They were randomly assigned to one of three intervention groups: (1) a MedDiet enriched with extra-virgin olive oil (EVOO) (n = 1998); (2) a MedDiet enriched with nuts (n = 1914), and a control group recommended to follow a low-fat diet (n = 1890). The incidence of cataract surgery was recorded yearly during follow-up clinical evaluations. Primary analyses were performed on an intention-to-treat basis. Cox regression analyses were used to assess the relationship between the nutritional intervention and the incidence of cataract surgery. Results: During a follow-up period of 7.0 years (mean follow-up period: 5.7 years; median: 5.9 years), 559 subjects underwent cataract surgery. Two hundred and six participants from the MedDiet + EVOO group, 174 from the MedDiet + Nuts group, and 179 from the control group underwent cataract surgery. We did not observe a reduction in the incidence of cataract surgery in the MedDiet groups compared to the control group. The multivariable adjusted hazard ratios were 1.03 (95% confidence interval [CI]: 0.84–1.26, p = 0.79) for the control group versus the MedDiet + EVOO group and 1.06 (95% CI: 0.86–1.31, p = 0.58) for the control group versus the MedDiet + Nuts group. Conclusions: To our knowledge, this is the first large randomized trial assessing the role of a MedDiet on the incidence of cataract surgery. Our results showed that the incidence of cataract surgery was similar in the MedDiet with EVOO, MedDiet with nuts, and low-fat diet groups. Further studies are necessary to investigate whether a MedDiet could have a preventive role in cataract surgery.
- Statistical and biological gene-lifestyle interactions of MC4R and FTO with diet and physical activity on obesity: new effects on alcohol consumption(Public Library of Science, 2012) Martinez-Gonzalez, M.A. (Miguel Ángel); Fiol, M. (Miquel); Ortega-Azorin, C. (Carolina); Gomez-Gracia, E. (Enrique); Ordovas, J.M. (Jose Maria); Carrasco, P. (Paula); Lapetra, J. (José); Coltell, O. (Oscar); Covas, M.I. (María Isabel); Ros, E. (Emilio); Estruch, R. (Ramón); Lamuela-Raventos, R.M. (Rosa Maria); Serra-Majem, L. (Luis); Corella, D. (Dolores); Pinto, X. (Xavier); Salas-Salvado, J. (Jordi); Sorli, J.V. (Jose V.); Aros, F. (Fernando); Marti-del-Moral, A. (Amelia)BACKGROUND: Fat mass and obesity (FTO) and melanocortin-4 receptor (MC4R) and are relevant genes associated with obesity. This could be through food intake, but results are contradictory. Modulation by diet or other lifestyle factors is also not well understood. OBJECTIVE: To investigate whether MC4R and FTO associations with body-weight are modulated by diet and physical activity (PA), and to study their association with alcohol and food intake. METHODS: Adherence to Mediterranean diet (AdMedDiet) and physical activity (PA) were assessed by validated questionnaires in 7,052 high cardiovascular risk subjects. MC4R rs17782313 and FTO rs9939609 were determined. Independent and joint associations (aggregate genetic score) as well as statistical and biological gene-lifestyle interactions were analyzed. RESULTS: FTO rs9939609 was associated with higher body mass index (BMI), waist circumference (WC) and obesity (P<0.05 for all). A similar, but not significant trend was found for MC4R rs17782313. Their additive effects (aggregate score) were significant and we observed a 7% per-allele increase of being obese (OR=1.07; 95%CI 1.01-1.13). We found relevant statistical interactions (P<0.05) with PA. So, in active individuals, the associations with higher BMI, WC or obesity were not detected. A biological (non-statistical) interaction between AdMedDiet and rs9939609 and the aggregate score was found. Greater AdMedDiet in individuals carrying 4 or 3-risk alleles counterbalanced their genetic predisposition, exhibiting similar BMI (P=0.502) than individuals with no risk alleles and lower AdMedDiet. They also had lower BMI (P=0.021) than their counterparts with low AdMedDiet. We did not find any consistent association with energy or macronutrients, but found a novel association between these polymorphisms and lower alcohol consumption in variant-allele carriers (B+/-SE: -0.57+/-0.16 g/d per-score-allele; P=0.001). CONCLUSION: Statistical and biological interactions with PA and diet modulate the effects of FTO and MC4R polymorphisms on obesity. The novel association with alcohol consumption seems independent of their effects on BMI.
- Impact of psychosocial factors on cardiovascular morbimortality: a prospective cohort study(BioMed Central, 2014) Castañer, O. (Olga); Martinez-Gonzalez, M.A. (Miguel Ángel); Fiol, M. (Miquel); Mejia-Lancheros, C. (Cilia); Diez-Espino, J. (Javier); Gomez-Gracia, E. (Enrique); Lapetra, J. (José); Muñoz, M.A. (Miguel Angel); Basora, J. (Josep); Ruiz-Gutierrez, V. (Valentina); Ros, E. (Emilio); Estruch, R. (Ramón); Lamuela-Raventos, R.M. (Rosa Maria); Serra-Majem, L. (Luis); Corella, D. (Dolores); Pinto, X. (Xavier); Salas-Salvado, J. (Jordi); Sorli, J.V. (Jose V.); Aros, F. (Fernando)Background: Whilst it is well known that psychosocial determinants may contribute to cardiovascular diseases (CVD), data from specific groups are scarce. The present study aims to determine the contribution of psychosocial determinants in increasing the risk of cardiovascular events (myocardial infarction and stroke), and death from CVD, in a high risk adult population. Methods: Longitudinal prospective study of 7263 patients (57.5% women), mean age 67.0 (SD 6.2) free from CVD but at high risk, with a median follow-up of 4.8 years (from October 2003 to December 2010). The Hazard Ratios (HRs) of cardiovascular events (myocardial infarction, stroke, and death from cardiovascular causes) related to educational attainment, diagnosed depression (based on medical records), and low social support (number of people living in the household) were estimated by multivariate Cox regression models. Results: Stroke incidence was associated with low educational level in the whole population (HR: 1.83, 95% CI: 1.09–3.09), and especially in men (HR: 2.11, 95% CI 1.09–4.06). Myocardial infarction and CVD mortality were not associated with any of the psychosocial factors considered. Conclusion: Adults with low educational level had a higher risk of stroke. Depression and low social support were not associated with CVD incidence. Trial registration: Clinical trial registration information unique identifier: ISRCTN35739639.
- Mercury exposure and risk of cardiovascular disease: a nested casecontrol study in the PREDIMED (PREvention with MEDiterranean Diet) study(Bio Med Central, 2017) Martinez-Gonzalez, M.A. (Miguel Ángel); Fiol, M. (Miquel); Fito, M. (Montserrat); Garcia-Rodriguez, A. (Antonio); Gomez-Gracia, E. (Enrique); Lapetra, J. (José); Muñoz, M.A. (Miguel Angel); Ros, E. (Emilio); Ruiz-Canela, M. (Miguel); Downer, M.K. (Mary Kathryn); Gutierrez-Bedmar, M. (Mario); Bullo, M. (Monica); Stampfer, M. (Meir); Wärnberg, J. (Julia); Estruch, R. (Ramón); Gea, A. (Alfredo); Serra-Majem, L. (Luis); Corella, D. (Dolores); Salas-Salvado, J. (Jordi); Sorli, J.V. (Jose V.); Aros, F. (Fernando)Background: Substantial evidence suggests that consuming 1–2 servings of fish per week, particularly oily fish (e.g., salmon, herring, sardines) is beneficial for cardiovascular health due to its high n-3 polyunsaturated fatty acid content. However, there is some concern that the mercury content in fish may increase cardiovascular disease risk, but this relationship remains unclear. Methods: The PREDIMED trial included 7477 participants who were at high risk for cardiovascular disease at baseline. In this study, we evaluated associations between mercury exposure, fish consumption and cardiovascular disease. We randomly selected 147 of the 288 cases diagnosed with cardiovascular disease during follow-up and matched them on age and sex to 267 controls. Instrumental neutron activation analysis was used to assess toenail mercury concentration. In-person interviews, medical record reviews and validated questionnaires were used to assess fish consumption and other covariates. Information was collected at baseline and updated yearly during follow-up. We used conditional logistic regression to evaluate associations in the total nested case-control study, and unconditional logistic regression for population subsets. Results: Mean (±SD) toenail mercury concentrations (μg per gram) did not significantly differ between cases (0.63 (±0.53)) and controls (0.67 (±0.49)). Mercury concentration was not associated with cardiovascular disease in any analysis, and neither was fish consumption or n-3 fatty acids. The fully-adjusted relative risks for the highest versus lowest quartile of mercury concentration were 0.71 (95% Confidence Interval [CI], 0.34, 1.14; ptrend = 0.37) for the nested case-control study, 0.74 (95% CI, 0.32, 1.76; ptrend = 0.43) within the Mediterranean diet intervention group, and 0.50 (95% CI, 0.13, 1.96; ptrend = 0.41) within the control arm of the trial. Associations remained null when mercury was jointly assessed with fish consumption at baseline and during follow-up. Results were similar in different sensitivity analyses.Conclusions: We found no evidence that mercury exposure from regular fish consumption increases cardiovascular disease risk in a population of Spanish adults with high cardiovascular disease risk and high fish consumption. This implies that the mercury content in fish does not detract from the already established cardiovascular benefits of fish consumption.
- Associations of the MCM6-rs3754686 proxy for milk intake in Mediterranean and American populations with cardiovascular biomarkers, disease and mortality: Mendelian randomization(Scientific Reports, 2016) Martinez-Gonzalez, M.A. (Miguel Ángel); Fiol, M. (Miquel); Fito, M. (Montserrat); Di, C. (Chongzhi); E. Smith, C. (Caren); Hidalgo, B. (Berta); Gomez-Gracia, E. (Enrique); Ordovas, J.M. (Jose Maria); L. Neuhouser, M. (Marian); L. Tucker, K. (Katherine); K. Arnett, D. (Donna); Coltell, O. (Oscar); Ros, E. (Emilio); Estruch, R. (Ramón); Miro, L. (Leticia); Q. Lai, C. (Chao); Serra-Majem, L. (Luis); Corella, D. (Dolores); Salas-Salvado, J. (Jordi); S. Dashti, H. (Hassan); Sorli, J.V. (Jose V.); Aros, F. (Fernando); Aslibekyan, S. (Stella)Controversy persists on the association between dairy products, especially milk, and cardiovascular diseases (CVD). Genetic proxies may improve dairy intake estimations, and clarify diet-disease relationships through Mendelian randomization. We meta-analytically (n ≤ 20,089) evaluated associations between a lactase persistence (LP) SNP, the minichromosome maintenance complex component 6 (MCM6)-rs3754686C>T (nonpersistence>persistence), dairy intake, and CVD biomarkers in American (Hispanics, African-American and Whites) and Mediterranean populations. Moreover, we analyzed longitudinal associations with milk, CVD and mortality in PREDIMED), a randomized Mediterranean diet (MedDiet) intervention trial (n = 7185). The MCM6-rs3754686/MCM6-rs309180 (as proxy), LP-allele (T) was strongly associated with higher milk intake, but inconsistently associated with glucose and lipids, and not associated with CVD or total mortality in the whole population. Heterogeneity analyses suggested some sex-specific associations. The T-allele was associated with higher CVD and mortality risk in women but not in men (P-sex interaction:0.005 and 0.032, respectively), mainly in the MedDiet group. However, milk intake was not associated with CVD biomarkers, CVD or mortality either generally or in sub-groups. Although MCM6-rs3754686 is a good milk intake proxy in these populations, attributing its associations with CVD and mortality in Mediterranean women to milk is unwarranted, as other factors limiting the assumption of causality in Mendelian randomization may exist.
- Arginine catabolism metabolites and atrial fibrillation or heart failure risk: 2 case-control studies within the Prevención con Dieta Mediterránea (PREDIMED) trial(Oxford University Press, 2022) Babio, N. (Nancy); Martinez-Gonzalez, M.A. (Miguel Ángel); Fiol, M. (Miquel); Clish, C.B. (Clary B.); Atzeni, A. (Alessandro); Fito, M. (Montserrat); Hu, F.B. (Frank B.); Wittenbecher, C. (Clemens); Li, J. (Jun); Gomez-Gracia, E. (Enrique); Toledo, E. (Estefanía); Goñi-Mateos, L. (Leticia); Lapetra, J. (José); Guasch-Ferre, M. (Marta); Razquin, C. (Cristina); Liang, L. (Liming); Ros, E. (Emilio); Ruiz-Canela, M. (Miguel); Alonso-Gomez, A. (Ángel); Dennis, C. (Courtney); Estruch, R. (Ramón); Serra-Majem, L. (Luis); Corella, D. (Dolores); Salas-Salvado, J. (Jordi); Aros, F. (Fernando)Background Arginine-derived metabolites are involved in oxidative and inflammatory processes related to endothelial functions and cardiovascular risks. Objectives We prospectively examined the associations of arginine catabolism metabolites with the risks of atrial fibrillation (AF) or heart failure (HF), and evaluated the potential modifications of these associations through Mediterranean diet (MedDiet) interventions in a large, primary-prevention trial. Methods Two nested, matched, case-control studies were designed within the Prevención con Dieta Mediterránea (PREDIMED) trial. We selected 509 incident cases and 547 matched controls for the AF case-control study and 326 cases and 402 matched controls for the HF case-control study using incidence density sampling. Fasting blood samples were collected at baseline and arginine catabolism metabolites were measured using LC-tandem MS. Multivariable conditional logistic regression models were applied to test the associations between the metabolites and incident AF or HF. Interactions between metabolites and intervention groups (MedDiet groups compared with control group) were analyzed with the likelihood ratio test. Results Inverse association with incident AF was observed for arginine (OR per 1 SD, 0.83; 95% CI: 0.73–0.94), whereas a positive association was found for N1-acetylspermidine (OR for Q4 compared with Q1 1.58; 95% CI: 1.13–2.25). For HF, inverse associations were found for arginine (OR per 1 SD, 0.82; 95% CI: 0.69–0.97) and homoarginine (OR per 1 SD, 0.81; 95% CI: 0.68–0.96), and positive associations were found for the asymmetric dimethylarginine (ADMA) and symmetric dimethlyarginine (SDMA) ratio (OR per 1 SD, 1.19; 95% CI: 1.02–1.41), N1-acetylspermidine (OR per 1 SD, 1.34; 95% CI: 1.12–1.60), and diacetylspermine (OR per 1 SD, 1.20; 95% CI: 1.02–1.41). In the stratified analysis according to the dietary intervention, the lower HF risk associated with arginine was restricted to participants in the MedDiet groups (P-interaction = 0.044). Conclusions Our results suggest that arginine catabolism metabolites could be involved in AF and HF. Interventions with the MedDiet may contribute to strengthen the inverse association between arginine and the risk of HF. This trial was registered at controlled-trials.com as ISRCTN35739639.
- Associations of the FTO rs9939609 and the MC4R rs17782313 polymorphisms with type 2 diabetes are modulated by diet, being higher when adherence to the mediterranean diet pattern is low(BioMed Central, 2012) Martinez-Gonzalez, M.A. (Miguel Ángel); Fiol, M. (Miquel); Saez-Tormo, G. (Guillermo); Ortega-Azorin, C. (Carolina); Gomez-Gracia, E. (Enrique); Ordovas, J.M. (Jose Maria); Lapetra, J. (José); Muñoz, M.A. (Miguel Angel); Coltell, O. (Oscar); Covas, M.I. (María Isabel); Ros, E. (Emilio); Estruch, R. (Ramón); Asensio, E.M. (Eva M.); Serra-Majem, L. (Luis); Corella, D. (Dolores); Pinto, X. (Xavier); Salas-Salvado, J. (Jordi); Sorli, J.V. (Jose V.); Aros, F. (Fernando)BACKGROUND: Although the fat mass and obesity (FTO) and melanocortin-4 receptor (MC4R) genes have been consistently associated with obesity risk, the association between the obesity-risk alleles with type 2 diabetes is still controversial. In some recent meta-analyses in which significant results have been reported, the associations disappeared after adjustment for body mass index (BMI). However gene-diet interactions with dietary patterns have not been investigated. Our main aim was to analyze whether these associations are modulated by the level of adherence to the Mediterranean Diet (MedDiet). METHODS: Case-control study in 7,052 high cardiovascular risk subjects (3,430 type 2 diabetes cases and 3,622 non-diabetic subjects) with no differences in BMI. Diet was assessed by validated questionnaires. FTO-rs9939609 and MC4R-rs17782313 were determined. An aggregate genetic score was calculated to test additive effects. Gene-diet interactions were analyzed. RESULTS: Neither of the polymorphisms was associated with type 2 diabetes in the whole population. However, we found consistent gene-diet interactions with adherence to the MedDiet both for the FTO-rs9939609 (P-interaction=0.039), the MC4R-rs17782313 (P-interaction=0.009) and for their aggregate score (P-interaction=0.006). When adherence to the MedDiet was low, carriers of the variant alleles had higher type 2 diabetes risk (OR=1.21, 95%CI: 1.03-1.40; P=0.019 for FTO-rs9939609 and OR=1.17, 95%CI:1.01-1.36; P=0.035 for MC4R-rs17782313) than wild-type subjects. However, when adherence to the MedDiet was high, these associations disappeared (OR=0.97, 95%CI: 0.85-1.16; P=0.673 for FTO-rs9939609 and OR=0.89, 95%CI:0.78-1.02; P=0.097 for MC4R-rs17782313). These gene-diet interactions remained significant even after adjustment for BMI. As MedDiet is rich in folate, we also specifically examined folate intake and detected statistically significant interaction effects on fasting plasma glucose concentrations in non-diabetic subjects. However these findings should be interpreted with caution because folate intake may simply reflect a healthy dietary pattern. CONCLUSIONS: These novel results suggest that the association of the FTO-rs9939609 and the MC4R-rs17782313 polymorphisms with type 2 diabetes depends on diet and that a high adherence to the MedDiet counteracts the genetic predisposition.
- Novel association of the obesity risk-allele near Fas Apoptotic Inhibitory Molecule 2 (FAIM2) gene with heart rate and study of its effects on myocardial infarction in diabetic participants of the PREDIMED trial(BioMed Central, 2014) Martinez-Gonzalez, M.A. (Miguel Ángel); Fiol, M. (Miquel); Ortega, C. (Carolina); Fito, M. (Montserrat); Gonzalez, J.I. (José I.); Gomez-Gracia, E. (Enrique); Ordovas, J.M. (Jose Maria); Lapetra, J. (José); Coltell, O. (Oscar); Ruiz-Gutierrez, V. (Valentina); Vinyoles, E. (Ernest); Ros, E. (Emilio); Bullo, M. (Monica); Estruch, R. (Ramón); Saiz, C. (Carmen); Serra-Majem, L. (Luis); Corella, D. (Dolores); Pinto, X. (Xavier); Sorli, J.V. (Jose V.); Aros, F. (Fernando); Marti-del-Moral, A. (Amelia)BACKGROUND: The Fas apoptotic pathway has been implicated in type 2 diabetes and cardiovascular disease. Although a polymorphism (rs7138803; G > A) near the Fas apoptotic inhibitory molecule 2 (FAIM2) locus has been related to obesity, its association with other cardiovascular risk factors and disease remains uncertain. METHODS: We analyzed the association between the FAIM2-rs7138803 polymorphism and obesity, blood pressure and heart rate in 7,161 participants (48.3% with type 2 diabetes) in the PREDIMED study at baseline. We also explored gene-diet interactions with adherence to the Mediterranean diet (MedDiet) and examined the effects of the polymorphism on cardiovascular disease incidence per diabetes status after a median 4.8-year dietary intervention (MedDiet versus control group) follow-up. RESULTS: We replicated the association between the FAIM2-rs7138803 polymorphism and greater obesity risk (OR: 1.08; 95% CI: 1.01-1.16; P = 0.011; per-A allele). Moreover, we detected novel associations of this polymorphism with higher diastolic blood pressure (DBP) and heart rate at baseline (B = 1.07; 95% CI: 0.97-1.28 bmp in AA vs G-carriers for the whole population), that remained statistically significant even after adjustment for body mass index (P = 0.012) and correction for multiple comparisons. This association was greater and statistically significant in type-2 diabetic subjects (B = 1.44: 95% CI: 0.23-2.56 bmp; P = 0.010 for AA versus G-carriers). Likewise, these findings were also observed longitudinally over 5-year follow-up. Nevertheless, we found no statistically significant gene-diet interactions with MedDiet for this trait. On analyzing myocardial infarction risk, we detected a nominally significant (P = 0.041) association in type-2 diabetic subjects (HR: 1.86; 95% CI:1.03-3.37 for AA versus G-carriers), although this association did not remain statistically significant following correction for multiple comparisons. CONCLUSIONS: We confirmed the FAIM2-rs7138803 relationship with obesity and identified novel and consistent associations with heart rate in particular in type 2 diabetic subjects. Furthermore, our results suggest a possible association of this polymorphism with higher myocardial infarction risk in type-2 diabetic subjects, although this result needs to be replicated as it could represent a false positive.
- Proteome of the early embryo-maternal dialogue in the cattle uterus(American Chemical Society, 2012) Mora, M.I. (María I.); Corrales, F.J. (Fernando José); Gomez-Gracia, E. (Enrique); Caamaño, J.N. (JN); Trigal, B. (Beatriz); Muñoz, M. (Marta); Diez, C. (Carmen); Martin, D. (David); Carrocera, S. (Susana)We analyzed embryo-maternal interactions in the bovine uterus on day 8 of development. Proteomic profiles were obtained by two-dimensional difference gel electrophoresis from 8 paired samples of uterine fluid (UF) from the same animal with and without embryos in the uterus. Results were contrasted with UF obtained after artificial insemination. We detected 50 differential protein spots (t test, p < 0.05). Subsequent protein characterization by nano-LC-ESI-MS/MS enabled us to identify 38 proteins, obtaining for first time the earliest evidence of involvement of the down-regulated NFkB system in cattle as a pregnancy signature pathway. Embryos enhanced the embryotrophic ability of UF and decreased uterine protein, while blood progesterone was unaltered. Twinfilin, hepatoma-derived growth factor, and synaptotagmin-binding cytoplasmic RNA interacting protein have not previously been identified in the mammalian uterus. TNFα and IL-1B were localized to embryos by immunocytochemistry, and other proteins were validated by Western blot in UF. Glycosylated-TNFα, IL-1B, insulin, lactotransferrin, nonphosphorylated-peroxiredoxin, albumin, purine nucleoside phosphorylase, HSPA5, and NFkB were down-regulated, while phosphorylated-peroxiredoxin, annexin A4, and nonglycosylated-TNFα were up-regulated. The embryonic signaling agents involved could be TNFα and IL-1B, either alone or in a collective dialogue with other proteins. Such molecules might explain the immune privilege during early bovine development.
- Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial(BioMed Central, 2013) Buil, P. (Pilar); Martinez-Gonzalez, M.A. (Miguel Ángel); Fiol, M. (Miquel); Hu, F.B. (Frank B.); Gomez-Gracia, E. (Enrique); Toledo, E. (Estefanía); Lapetra, J. (José); Ruiz-Gutierrez, V. (Valentina); Covas, M.I. (María Isabel); Ros, E. (Emilio); Bullo, M. (Monica); Estruch, R. (Ramón); Lamuela-Raventos, R.M. (Rosa Maria); Serra-Majem, L. (Luis); Corella, D. (Dolores); Pinto, X. (Xavier); Salas-Salvado, J. (Jordi); Sorli, J.V. (Jose V.); Aros, F. (Fernando); Saez, G. (Guillermo)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.