Enrique Gómez-gracia | Universidad de Málaga (original) (raw)

Papers by Enrique Gómez-gracia

Research paper thumbnail of Fecundación in vitro y transferencia de embriones (FIVET)

Anuario Filosófico

The epidemological analysis of data regarding the efficacy of artificial reproduction techniques ... more The epidemological analysis of data regarding the efficacy of artificial reproduction techniques reveáis certain problems in those most widely used. Aside from these empirical difficulties comes the affront on human dignity that some of them entail. It is necessary to deal with the problem of sterility in a manner that safeguards the excellence of the human being.

Research paper thumbnail of Drogodependencias y salud pública

Research paper thumbnail of Eutanasia y salud pública

Research paper thumbnail of Red wine consumption is associated with a low prevalence of metabolic 1 syndrome in the PREDIMED population . 2

Previous studies on the relationship between alcohol intake and the development of the metabolic ... more Previous studies on the relationship between alcohol intake and the development of the metabolic syndrome (MetS) have yielded inconsistent results. Besides, few studies have analyzed the effects of red wine (RW) on prevalence of MetS and its components. Since moderate RW drinkers have shown a better lipid profile and lower incidence of diabetes, hypertension and abdominal obesity, all components of the MetS, we hypothesized that moderate RW intake could related to a lower MetS prevalence. In a cross-sectional study of 5801 elderly subjects at high cardiovascular risk included in the PREDIMED trial, 3897 fulfilled the criteria of MetS at baseline. Red wine intake was recorded using a validated 137-item food frequency questionnaire and the MetS was defined according to the Adult Treatment Panel III criteria. We used multiple logistic regressions to estimate the association between RW intake and the MetS. Compared to non-drinkers, moderate RW drinkers (≥1 drinks/d) showed a reduced risk of prevalent MetS (OR 0•56, 95% CI 0•45, 0•68; P<0•001), a lower risk of having abnormal waist circumference (OR 0•59, 95% CI 0•46, 0•77; P<0•001), low HDL-cholesterol (OR 0•42, CI 0•32, 0•53; P<0•001), high blood pressure (OR 0•28, 95% CI 0•17, 0•45; P<0•001) and high fasting plasma glucose levels (OR 0•67, CI 0•54, 0•82; P<0•001), after adjusting for several confounders. This association was stronger for women, for participants under 70 years of age and for those who were former or current smokers. We found no significant association between RW intake (≥1 drinks/d) and triglyceride concentrations. In conclusion, moderate RW intake is associated with a lower prevalence of MetS in an elderly Mediterranean population at high cardiovascular risk.

Research paper thumbnail of Dysfunctional High-Density Lipoproteins Are Associated With a Greater Incidence of Acute Coronary Syndrome in a Population at High Cardiovascular Risk

Circulation, 2020

Background: Studies have failed to establish a clear link between high-density lipoprotein (HDL) ... more Background: Studies have failed to establish a clear link between high-density lipoprotein (HDL) cholesterol and cardiovascular disease, leading to the hypothesis that the atheroprotective role of HDL lies in its biological activity rather than in its cholesterol content. However, to date, the association between HDL functional characteristics and acute coronary syndrome has not been investigated comprehensively. Methods: We conducted a case-control study nested within the PREDIMED (Prevención con Dieta Mediterránea) cohort, originally a randomized trial in which participants followed a Mediterranean or low-fat diet. Incident acute coronary syndrome cases (N=167) were individually matched (1:2) to control patients by sex, age, intervention group, body mass index, and follow-up time. We investigated 2 individual manifestations (myocardial infarction, unstable angina) as secondary outcomes. We measured the following functional characteristics: HDL cholesterol concentration (in plasma)...

Research paper thumbnail of Increased Consumption of Virgin Olive Oil, Nuts, Legumes, Whole Grains, and Fish Promotes HDL Functions in Humans

Molecular Nutrition & Food Research, 2019

Research paper thumbnail of Associations between Both Lignan and Yogurt Consumption and Cardiovascular Risk Parameters in an Elderly Population: Observations from a Cross-Sectional Approach in the PREDIMED Study

Journal of the Academy of Nutrition and Dietetics, Jan 29, 2016

The study of dietary patterns is gaining interest. Although the health benefits of yogurt and lig... more The study of dietary patterns is gaining interest. Although the health benefits of yogurt and lignans have been investigated separately, to our knowledge there are no studies on their associative effects. The aim of this study was to evaluate a possible association between yogurt and lignans using biomarkers of cardiovascular disease risk in an elderly population. We conducted a cross-sectional analysis of the association between baseline dietary information and cardiovascular risk parameters using food frequency questionnaires. We enrolled 7,169 Spanish participants of the PREDIMED (Prevención con Dieta Mediterránea) study (elderly men and women at high cardiovascular risk) from June 2003 to June 2009. Cardiovascular risk parameters, including cholesterol, triglycerides, glucose, body mass index, weight, waist circumference, and blood pressure were measured. General linear models were used to assess the relationship between categorical variables (yogurt, total dairy intake, lignans...

Research paper thumbnail of Dietary intake and major food sources of polyphenols in a Spanish population at high cardiovascular risk: The PREDIMED study

Nutrition, Metabolism and Cardiovascular Diseases, 2013

Methods We studied 2573 men and women aged 50-75 years. Among others, anthropometry was measured ... more Methods We studied 2573 men and women aged 50-75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits Abstract Purpose Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups.

Research paper thumbnail of Methodological quality and reporting of ethical requirements in clinical trials

Journal of Medical Ethics, 2001

Objectives-To assess the relationship between the approval of trials by a research ethics committ... more Objectives-To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. Design-Systematic review using a standardised checklist. Main measures-Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published by at least one Spanish author during the same period in any other journal were also included. Results-We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groups Conclusion-Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects.

Research paper thumbnail of Smoking Status, Changes in Smoking Status and Health-Related Quality of Life: Findings from the SUN (“Seguimiento Universidad de Navarra”) Cohort

International Journal of Environmental Research and Public Health, 2009

We aimed to evaluate the association between smoking, changes in smoking, and quality of life in ... more We aimed to evaluate the association between smoking, changes in smoking, and quality of life in a cohort of Spanish university graduates. Smoking habits were selfreported at baseline and four years later. Quality of life was assessed using the Short Form-36 (SF-36) at year 4. Statistical differences in SF-36 scores between groups were determined using ANCOVA with age and sex as covariates. Out of 5,234 eligible participants over 2000-2006, there were 2,639 non-smoker participants, 1,419 ex-smokers, and 1,048 smokers. Within the previous four years, 435 participants became recent quitters and 205 starters. Comparing smoking and health status in year 4, non-smokers showed better scores than the other categories of ever smoking in all dimensions except in the vitality scale value, which was similar in non-smokers and in those smoking less than 15 cigarettes/day. Comparing changes in smoking and health in year 4, continuing smokers had statistically significant worse scores than non-smokers in general health, social functioning, role-emotional and mental health, whereas recent quitters showed statistically significant improvements in role-emotional and mental health over those who had continued smoking or those who became smokers. Our findings support a dose-response relationship between

Research paper thumbnail of Mediterranean alcohol drinking pattern and risk of atrial fibrillation in the PREDIMED study

Research paper thumbnail of Mediterranean diet , retinopathy and nephropathy microvascular diabetes complications : A post hoc analysis of a randomized trial

Objective: To date no clinical trials have evaluated the role of dietary patterns on the incidenc... more Objective: To date no clinical trials have evaluated the role of dietary patterns on the incidence of microvascular diabetes complications. We hypothesized that a nutritional intervention based on the Mediterranean diet would have greater protective effect on diabetic retinopathy and nephropathy than a low-fat control diet. Research design and methods: Post hoc analysis of a cohort of patients with type 2 diabetes participating in the PREvención con DIeta MEDiterránea (PREDIMED) study, a multi-center randomized nutritional intervention trial conducted in a population at high cardiovascular risk. Individuals with type 2 diabetes who were free of microvascular complications at enrolment (3614 participants, aged 55-80 years) were randomly assigned to one of three dietary interventions: MedDiet supplemented with extra virgin olive oil (MedDiet+EVOO), supplemented with mixed nuts (MedDiet+Nuts), or a low-fat control diet. Two independent outcomes were considered: new-onset of diabetic retinopathy and nephropathy. Hazard ratios (HRs) were calculated using multivariable-adjusted Cox regression. Results: During a median follow-up of 6.0 years, we identified 74 and 168 new cases of retinopathy and nephropathy, respectively. In comparison with the control diet, multivariableadjusted HRs for diabetic retinopathy were 0.56 (95%CI, 0.32-0.97) for the MedDiet+EVOO and 0.63 (0.35-1.11) for the MedDiet+Nuts. No between-group differences were found for nephropathy. When the yearly updated information on adherence to the MedDiet was considered, the HR for retinopathy in the highest vs the lowest quintile was 0.34 (0.13-0.89); P-trend =0.001. No significant associations were found for nephropathy. Conclusions: A Mediterranean diet enriched with EVOO may protect against diabetic retinopathy but not diabetic nephropathy.

Research paper thumbnail of Metabolomics of the tryptophan–kynurenine degradation pathway and risk of atrial fibrillation and heart failure: potential modification effect of Mediterranean diet

The American Journal of Clinical Nutrition, 2021

Background The tryptophan–kynurenine pathway is linked to inflammation. We hypothesize that metab... more Background The tryptophan–kynurenine pathway is linked to inflammation. We hypothesize that metabolites implicated in this pathway may be associated with the risk of heart failure (HF) or atrial fibrillation (AF) in a population at high risk of cardiovascular disease. Objectives We aimed to prospectively analyze the associations of kynurenine-related metabolites with the risk of HF and AF and to analyze a potential effect modification by the randomized interventions of the PREDIMED (Prevención con Dieta Mediterránea) trial with Mediterranean diet (MedDiet). Methods Two case–control studies nested within the PREDIMED trial were designed. We selected 324 incident HF cases and 502 incident AF cases individually matched with ≤3 controls. Conditional logistic regression models were fitted. Interactions with the intervention were tested for each of the baseline plasma metabolites measured by LC–tandem MS. Results Higher baseline kynurenine:tryptophan ratio (OR for 1 SD: 1.20; 95% CI: 1.01...

Research paper thumbnail of Simple sugar intake and cancer incidence, cancer mortality and all-cause mortality: A cohort study from the PREDIMED trial

Clinical Nutrition, 2021

Objective: To examine associations between intake of simple sugars and cancer incidence, cancer m... more Objective: To examine associations between intake of simple sugars and cancer incidence, cancer mortality, and total mortality in a prospective cohort study based on the PREDIMED trial conducted from 2003 to 2010. Methods: Participants were older individuals at high cardiovascular risk. Exposures were total sugar, glucose and fructose from solid or liquid sources, and fructose from fruit and 100% fruit juice. Cancer incidence was the primary outcome; cancer mortality and all-cause mortality were secondary outcomes. Multivariable-adjusted, time-dependent Cox proportional hazard models were used. Results: Of 7447 individuals enrolled, 7056 (94.7%) were included (57.6% women, aged 67.0 ± 6.2 years). 534 incident cancers with 152 cancer deaths and 409 all-cause deaths were recorded after a median follow-up of 6 years. Intake of simple sugars in solid form was unrelated to outcomes. Higher cancer

Research paper thumbnail of Longitudinal association of changes in diet with changes in body weight and waist circumference in subjects at high cardiovascular risk: the PREDIMED trial

International Journal of Behavioral Nutrition and Physical Activity, 2019

Background Consumption of certain foods is associated with long-term weight gains and abdominal f... more Background Consumption of certain foods is associated with long-term weight gains and abdominal fat accumulation in healthy, middle-aged and young, non-obese participants. Whether the same foods might be associated with changes in adiposity in elderly population at high cardiovascular risk is less known. Objective Using yearly repeated measurements of both food habits and adiposity parameters, we aimed to investigate how changes in the consumption of specific foods were associated with concurrent changes in weight or waist circumference (WC) in the PREDIMED trial. Design We followed-up 7009 participants aged 55–70 years at high cardiovascular risk for a median time of 4.8 years. A validated 137-item semi-quantitative Food Frequency Questionnaire was used for dietary assessment with yearly repeated measurements. We longitudinally assessed associations between yearly changes in food consumption (serving/d) and concurrent changes in weight (kg) or WC (cm). Results Yearly increments in ...

Research paper thumbnail of Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic Syndrome

JAMA, 2019

IMPORTANCE High-quality dietary patterns may help prevent chronic disease, but limited data exist... more IMPORTANCE High-quality dietary patterns may help prevent chronic disease, but limited data exist from randomized trials about the effects of nutritional and behavioral interventions on dietary changes. OBJECTIVE To assess the effect of a nutritional and physical activity education program on dietary quality. DESIGN, SETTING, AND PARTICIPANTS Preliminary exploratory interim analysis of an ongoing randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years with metabolic syndrome and no cardiovascular disease were enrolled in the trial between September 2013 and December 2016, with final data collection in March 2019. INTERVENTIONS Participants were randomized to an intervention group that encouraged an energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral support (n = 3406) or to a control group that encouraged an energy-unrestricted Mediterranean diet (n = 3468). All participants received allotments of extra-virgin olive oil (1 L/mo) and nuts (125 g/mo) for free. MAIN OUTCOMES AND MEASURES The primary outcome was 12-month change in adherence based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher scores indicate greater adherence; minimal clinically important difference, 1 point). RESULTS Among 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406 [52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months in the intervention group (increase, 4.7 [95% CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months in the control group (increase, 2.5 [95% CI, 2.3-2.6]) (between-group difference, 2.2 [95% CI, 2.1-2.4]; P < .001). CONCLUSIONS AND RELEVANCE In this preliminary analysis of an ongoing trial, an intervention that encouraged an energy-reduced Mediterranean diet and physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular effects is needed.

Research paper thumbnail of Impacto de Life's Simple 7 en la incidencia de eventos cardiovasculares mayores en adultos españoles con alto riesgo de la cohorte del estudio PREDIMED

Revista Española de Cardiología, 2019

Có mo citar este artículo: Díez-Espino J, et al. Impacto de Life's Simple 7 en la incidencia de e... more Có mo citar este artículo: Díez-Espino J, et al. Impacto de Life's Simple 7 en la incidencia de eventos cardiovasculares mayores en adultos españ oles con alto riesgo de la cohorte del estudio PREDIMED.

Research paper thumbnail of Quality of Dietary Fat Intake and Body Weight and Obesity in a Mediterranean Population: Secondary Analyses within the PREDIMED Trial

Nutrients, 2018

A moderately high-fat Mediterranean diet does not promote weight gain. This study aimed to invest... more A moderately high-fat Mediterranean diet does not promote weight gain. This study aimed to investigate the association between dietary intake of specific types of fat and obesity and body weight. A prospective cohort study was performed using data of 6942 participants in the PREDIMED trial, with yearly repeated validated food-frequency questionnaires, and anthropometric outcomes (median follow-up: 4.8 years). The effects of replacing dietary fat subtypes for one another, proteins or carbohydrates were estimated using generalized estimating equations substitution models. Replacement of 5% energy from saturated fatty acids (SFA) with monounsaturated fatty acids (MUFA) or polyunsaturated fatty acids (PUFA) resulted in weight changes of −0.38 kg (95% Confidece Iinterval (CI): −0.69, −0.07), and −0.51 kg (95% CI: −0.81, −0.20), respectively. Replacing proteins with MUFA or PUFA decreased the odds of becoming obese. Estimates for the daily substitution of one portion of red meat with whit...

Research paper thumbnail of Lipid metabolic networks, Mediterranean diet and cardiovascular disease in the PREDIMED trial

International Journal of Epidemiology, 2018

Background: Perturbed lipid metabolic pathways may play important roles in the development of car... more Background: Perturbed lipid metabolic pathways may play important roles in the development of cardiovascular disease (CVD). However, existing epidemiological studies have focused more on discovering individual lipid metabolites for CVD risk prediction rather than assessing metabolic pathways.

Research paper thumbnail of 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

Journal of the Academy of Nutrition and Dietetics, 2018

Oxidatively induced DNA damage, an important factor in cancer etiology, is repaired by oxyguanine... more 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. 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. Secondary analysis in the PREDIMED (Prevención con Dieta Mediterránea) trial is a randomized, controlled trial conducted in Spain from 2003 to 2010. Study participants (n=7,170) were at high risk for CVD and were aged 55 to 80 years. Participants were randomly allocated to two groups with a Mediterranean diet intervention or a control die...

Research paper thumbnail of Fecundación in vitro y transferencia de embriones (FIVET)

Anuario Filosófico

The epidemological analysis of data regarding the efficacy of artificial reproduction techniques ... more The epidemological analysis of data regarding the efficacy of artificial reproduction techniques reveáis certain problems in those most widely used. Aside from these empirical difficulties comes the affront on human dignity that some of them entail. It is necessary to deal with the problem of sterility in a manner that safeguards the excellence of the human being.

Research paper thumbnail of Drogodependencias y salud pública

Research paper thumbnail of Eutanasia y salud pública

Research paper thumbnail of Red wine consumption is associated with a low prevalence of metabolic 1 syndrome in the PREDIMED population . 2

Previous studies on the relationship between alcohol intake and the development of the metabolic ... more Previous studies on the relationship between alcohol intake and the development of the metabolic syndrome (MetS) have yielded inconsistent results. Besides, few studies have analyzed the effects of red wine (RW) on prevalence of MetS and its components. Since moderate RW drinkers have shown a better lipid profile and lower incidence of diabetes, hypertension and abdominal obesity, all components of the MetS, we hypothesized that moderate RW intake could related to a lower MetS prevalence. In a cross-sectional study of 5801 elderly subjects at high cardiovascular risk included in the PREDIMED trial, 3897 fulfilled the criteria of MetS at baseline. Red wine intake was recorded using a validated 137-item food frequency questionnaire and the MetS was defined according to the Adult Treatment Panel III criteria. We used multiple logistic regressions to estimate the association between RW intake and the MetS. Compared to non-drinkers, moderate RW drinkers (≥1 drinks/d) showed a reduced risk of prevalent MetS (OR 0•56, 95% CI 0•45, 0•68; P<0•001), a lower risk of having abnormal waist circumference (OR 0•59, 95% CI 0•46, 0•77; P<0•001), low HDL-cholesterol (OR 0•42, CI 0•32, 0•53; P<0•001), high blood pressure (OR 0•28, 95% CI 0•17, 0•45; P<0•001) and high fasting plasma glucose levels (OR 0•67, CI 0•54, 0•82; P<0•001), after adjusting for several confounders. This association was stronger for women, for participants under 70 years of age and for those who were former or current smokers. We found no significant association between RW intake (≥1 drinks/d) and triglyceride concentrations. In conclusion, moderate RW intake is associated with a lower prevalence of MetS in an elderly Mediterranean population at high cardiovascular risk.

Research paper thumbnail of Dysfunctional High-Density Lipoproteins Are Associated With a Greater Incidence of Acute Coronary Syndrome in a Population at High Cardiovascular Risk

Circulation, 2020

Background: Studies have failed to establish a clear link between high-density lipoprotein (HDL) ... more Background: Studies have failed to establish a clear link between high-density lipoprotein (HDL) cholesterol and cardiovascular disease, leading to the hypothesis that the atheroprotective role of HDL lies in its biological activity rather than in its cholesterol content. However, to date, the association between HDL functional characteristics and acute coronary syndrome has not been investigated comprehensively. Methods: We conducted a case-control study nested within the PREDIMED (Prevención con Dieta Mediterránea) cohort, originally a randomized trial in which participants followed a Mediterranean or low-fat diet. Incident acute coronary syndrome cases (N=167) were individually matched (1:2) to control patients by sex, age, intervention group, body mass index, and follow-up time. We investigated 2 individual manifestations (myocardial infarction, unstable angina) as secondary outcomes. We measured the following functional characteristics: HDL cholesterol concentration (in plasma)...

Research paper thumbnail of Increased Consumption of Virgin Olive Oil, Nuts, Legumes, Whole Grains, and Fish Promotes HDL Functions in Humans

Molecular Nutrition & Food Research, 2019

Research paper thumbnail of Associations between Both Lignan and Yogurt Consumption and Cardiovascular Risk Parameters in an Elderly Population: Observations from a Cross-Sectional Approach in the PREDIMED Study

Journal of the Academy of Nutrition and Dietetics, Jan 29, 2016

The study of dietary patterns is gaining interest. Although the health benefits of yogurt and lig... more The study of dietary patterns is gaining interest. Although the health benefits of yogurt and lignans have been investigated separately, to our knowledge there are no studies on their associative effects. The aim of this study was to evaluate a possible association between yogurt and lignans using biomarkers of cardiovascular disease risk in an elderly population. We conducted a cross-sectional analysis of the association between baseline dietary information and cardiovascular risk parameters using food frequency questionnaires. We enrolled 7,169 Spanish participants of the PREDIMED (Prevención con Dieta Mediterránea) study (elderly men and women at high cardiovascular risk) from June 2003 to June 2009. Cardiovascular risk parameters, including cholesterol, triglycerides, glucose, body mass index, weight, waist circumference, and blood pressure were measured. General linear models were used to assess the relationship between categorical variables (yogurt, total dairy intake, lignans...

Research paper thumbnail of Dietary intake and major food sources of polyphenols in a Spanish population at high cardiovascular risk: The PREDIMED study

Nutrition, Metabolism and Cardiovascular Diseases, 2013

Methods We studied 2573 men and women aged 50-75 years. Among others, anthropometry was measured ... more Methods We studied 2573 men and women aged 50-75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits Abstract Purpose Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups.

Research paper thumbnail of Methodological quality and reporting of ethical requirements in clinical trials

Journal of Medical Ethics, 2001

Objectives-To assess the relationship between the approval of trials by a research ethics committ... more Objectives-To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. Design-Systematic review using a standardised checklist. Main measures-Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published by at least one Spanish author during the same period in any other journal were also included. Results-We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groups Conclusion-Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects.

Research paper thumbnail of Smoking Status, Changes in Smoking Status and Health-Related Quality of Life: Findings from the SUN (“Seguimiento Universidad de Navarra”) Cohort

International Journal of Environmental Research and Public Health, 2009

We aimed to evaluate the association between smoking, changes in smoking, and quality of life in ... more We aimed to evaluate the association between smoking, changes in smoking, and quality of life in a cohort of Spanish university graduates. Smoking habits were selfreported at baseline and four years later. Quality of life was assessed using the Short Form-36 (SF-36) at year 4. Statistical differences in SF-36 scores between groups were determined using ANCOVA with age and sex as covariates. Out of 5,234 eligible participants over 2000-2006, there were 2,639 non-smoker participants, 1,419 ex-smokers, and 1,048 smokers. Within the previous four years, 435 participants became recent quitters and 205 starters. Comparing smoking and health status in year 4, non-smokers showed better scores than the other categories of ever smoking in all dimensions except in the vitality scale value, which was similar in non-smokers and in those smoking less than 15 cigarettes/day. Comparing changes in smoking and health in year 4, continuing smokers had statistically significant worse scores than non-smokers in general health, social functioning, role-emotional and mental health, whereas recent quitters showed statistically significant improvements in role-emotional and mental health over those who had continued smoking or those who became smokers. Our findings support a dose-response relationship between

Research paper thumbnail of Mediterranean alcohol drinking pattern and risk of atrial fibrillation in the PREDIMED study

Research paper thumbnail of Mediterranean diet , retinopathy and nephropathy microvascular diabetes complications : A post hoc analysis of a randomized trial

Objective: To date no clinical trials have evaluated the role of dietary patterns on the incidenc... more Objective: To date no clinical trials have evaluated the role of dietary patterns on the incidence of microvascular diabetes complications. We hypothesized that a nutritional intervention based on the Mediterranean diet would have greater protective effect on diabetic retinopathy and nephropathy than a low-fat control diet. Research design and methods: Post hoc analysis of a cohort of patients with type 2 diabetes participating in the PREvención con DIeta MEDiterránea (PREDIMED) study, a multi-center randomized nutritional intervention trial conducted in a population at high cardiovascular risk. Individuals with type 2 diabetes who were free of microvascular complications at enrolment (3614 participants, aged 55-80 years) were randomly assigned to one of three dietary interventions: MedDiet supplemented with extra virgin olive oil (MedDiet+EVOO), supplemented with mixed nuts (MedDiet+Nuts), or a low-fat control diet. Two independent outcomes were considered: new-onset of diabetic retinopathy and nephropathy. Hazard ratios (HRs) were calculated using multivariable-adjusted Cox regression. Results: During a median follow-up of 6.0 years, we identified 74 and 168 new cases of retinopathy and nephropathy, respectively. In comparison with the control diet, multivariableadjusted HRs for diabetic retinopathy were 0.56 (95%CI, 0.32-0.97) for the MedDiet+EVOO and 0.63 (0.35-1.11) for the MedDiet+Nuts. No between-group differences were found for nephropathy. When the yearly updated information on adherence to the MedDiet was considered, the HR for retinopathy in the highest vs the lowest quintile was 0.34 (0.13-0.89); P-trend =0.001. No significant associations were found for nephropathy. Conclusions: A Mediterranean diet enriched with EVOO may protect against diabetic retinopathy but not diabetic nephropathy.

Research paper thumbnail of Metabolomics of the tryptophan–kynurenine degradation pathway and risk of atrial fibrillation and heart failure: potential modification effect of Mediterranean diet

The American Journal of Clinical Nutrition, 2021

Background The tryptophan–kynurenine pathway is linked to inflammation. We hypothesize that metab... more Background The tryptophan–kynurenine pathway is linked to inflammation. We hypothesize that metabolites implicated in this pathway may be associated with the risk of heart failure (HF) or atrial fibrillation (AF) in a population at high risk of cardiovascular disease. Objectives We aimed to prospectively analyze the associations of kynurenine-related metabolites with the risk of HF and AF and to analyze a potential effect modification by the randomized interventions of the PREDIMED (Prevención con Dieta Mediterránea) trial with Mediterranean diet (MedDiet). Methods Two case–control studies nested within the PREDIMED trial were designed. We selected 324 incident HF cases and 502 incident AF cases individually matched with ≤3 controls. Conditional logistic regression models were fitted. Interactions with the intervention were tested for each of the baseline plasma metabolites measured by LC–tandem MS. Results Higher baseline kynurenine:tryptophan ratio (OR for 1 SD: 1.20; 95% CI: 1.01...

Research paper thumbnail of Simple sugar intake and cancer incidence, cancer mortality and all-cause mortality: A cohort study from the PREDIMED trial

Clinical Nutrition, 2021

Objective: To examine associations between intake of simple sugars and cancer incidence, cancer m... more Objective: To examine associations between intake of simple sugars and cancer incidence, cancer mortality, and total mortality in a prospective cohort study based on the PREDIMED trial conducted from 2003 to 2010. Methods: Participants were older individuals at high cardiovascular risk. Exposures were total sugar, glucose and fructose from solid or liquid sources, and fructose from fruit and 100% fruit juice. Cancer incidence was the primary outcome; cancer mortality and all-cause mortality were secondary outcomes. Multivariable-adjusted, time-dependent Cox proportional hazard models were used. Results: Of 7447 individuals enrolled, 7056 (94.7%) were included (57.6% women, aged 67.0 ± 6.2 years). 534 incident cancers with 152 cancer deaths and 409 all-cause deaths were recorded after a median follow-up of 6 years. Intake of simple sugars in solid form was unrelated to outcomes. Higher cancer

Research paper thumbnail of Longitudinal association of changes in diet with changes in body weight and waist circumference in subjects at high cardiovascular risk: the PREDIMED trial

International Journal of Behavioral Nutrition and Physical Activity, 2019

Background Consumption of certain foods is associated with long-term weight gains and abdominal f... more Background Consumption of certain foods is associated with long-term weight gains and abdominal fat accumulation in healthy, middle-aged and young, non-obese participants. Whether the same foods might be associated with changes in adiposity in elderly population at high cardiovascular risk is less known. Objective Using yearly repeated measurements of both food habits and adiposity parameters, we aimed to investigate how changes in the consumption of specific foods were associated with concurrent changes in weight or waist circumference (WC) in the PREDIMED trial. Design We followed-up 7009 participants aged 55–70 years at high cardiovascular risk for a median time of 4.8 years. A validated 137-item semi-quantitative Food Frequency Questionnaire was used for dietary assessment with yearly repeated measurements. We longitudinally assessed associations between yearly changes in food consumption (serving/d) and concurrent changes in weight (kg) or WC (cm). Results Yearly increments in ...

Research paper thumbnail of Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic Syndrome

JAMA, 2019

IMPORTANCE High-quality dietary patterns may help prevent chronic disease, but limited data exist... more IMPORTANCE High-quality dietary patterns may help prevent chronic disease, but limited data exist from randomized trials about the effects of nutritional and behavioral interventions on dietary changes. OBJECTIVE To assess the effect of a nutritional and physical activity education program on dietary quality. DESIGN, SETTING, AND PARTICIPANTS Preliminary exploratory interim analysis of an ongoing randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years with metabolic syndrome and no cardiovascular disease were enrolled in the trial between September 2013 and December 2016, with final data collection in March 2019. INTERVENTIONS Participants were randomized to an intervention group that encouraged an energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral support (n = 3406) or to a control group that encouraged an energy-unrestricted Mediterranean diet (n = 3468). All participants received allotments of extra-virgin olive oil (1 L/mo) and nuts (125 g/mo) for free. MAIN OUTCOMES AND MEASURES The primary outcome was 12-month change in adherence based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher scores indicate greater adherence; minimal clinically important difference, 1 point). RESULTS Among 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406 [52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months in the intervention group (increase, 4.7 [95% CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months in the control group (increase, 2.5 [95% CI, 2.3-2.6]) (between-group difference, 2.2 [95% CI, 2.1-2.4]; P < .001). CONCLUSIONS AND RELEVANCE In this preliminary analysis of an ongoing trial, an intervention that encouraged an energy-reduced Mediterranean diet and physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular effects is needed.

Research paper thumbnail of Impacto de Life's Simple 7 en la incidencia de eventos cardiovasculares mayores en adultos españoles con alto riesgo de la cohorte del estudio PREDIMED

Revista Española de Cardiología, 2019

Có mo citar este artículo: Díez-Espino J, et al. Impacto de Life's Simple 7 en la incidencia de e... more Có mo citar este artículo: Díez-Espino J, et al. Impacto de Life's Simple 7 en la incidencia de eventos cardiovasculares mayores en adultos españ oles con alto riesgo de la cohorte del estudio PREDIMED.

Research paper thumbnail of Quality of Dietary Fat Intake and Body Weight and Obesity in a Mediterranean Population: Secondary Analyses within the PREDIMED Trial

Nutrients, 2018

A moderately high-fat Mediterranean diet does not promote weight gain. This study aimed to invest... more A moderately high-fat Mediterranean diet does not promote weight gain. This study aimed to investigate the association between dietary intake of specific types of fat and obesity and body weight. A prospective cohort study was performed using data of 6942 participants in the PREDIMED trial, with yearly repeated validated food-frequency questionnaires, and anthropometric outcomes (median follow-up: 4.8 years). The effects of replacing dietary fat subtypes for one another, proteins or carbohydrates were estimated using generalized estimating equations substitution models. Replacement of 5% energy from saturated fatty acids (SFA) with monounsaturated fatty acids (MUFA) or polyunsaturated fatty acids (PUFA) resulted in weight changes of −0.38 kg (95% Confidece Iinterval (CI): −0.69, −0.07), and −0.51 kg (95% CI: −0.81, −0.20), respectively. Replacing proteins with MUFA or PUFA decreased the odds of becoming obese. Estimates for the daily substitution of one portion of red meat with whit...

Research paper thumbnail of Lipid metabolic networks, Mediterranean diet and cardiovascular disease in the PREDIMED trial

International Journal of Epidemiology, 2018

Background: Perturbed lipid metabolic pathways may play important roles in the development of car... more Background: Perturbed lipid metabolic pathways may play important roles in the development of cardiovascular disease (CVD). However, existing epidemiological studies have focused more on discovering individual lipid metabolites for CVD risk prediction rather than assessing metabolic pathways.

Research paper thumbnail of 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

Journal of the Academy of Nutrition and Dietetics, 2018

Oxidatively induced DNA damage, an important factor in cancer etiology, is repaired by oxyguanine... more 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. 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. Secondary analysis in the PREDIMED (Prevención con Dieta Mediterránea) trial is a randomized, controlled trial conducted in Spain from 2003 to 2010. Study participants (n=7,170) were at high risk for CVD and were aged 55 to 80 years. Participants were randomly allocated to two groups with a Mediterranean diet intervention or a control die...