Cohort Profile: Design and methods of the PREDIMED-Plus randomized trial
The PREDIMED (in Spanish: PREvención con DIeta MEDiterránea) primary prevention trial1–3 reported in 2013 that long-term adherence to an energy-unrestricted Mediterranean diet (MedDiet), supplemented with either extra-virgin olive oil (EVOO) or nuts, reduced cardiovascular disease (CVD). PREDIMED showed a 30% relative reduction in the composite cardiovascular primary endpoint (stroke, myocardial infarction or cardiovascular death).2,,3 However, the PREDIMED trial tested only the composition of the diet, but did not test other lifestyle interventions (i.e. energy reduction, increased physical activity (PA) and behavioural modification) frequently applied in the context of the current unprece…
Associations Between the Modified Food Standard Agency Nutrient Profiling System Dietary Index and Cardiovascular Risk Factors in an Elderly Population.
Background: Helping consumers to improve the nutritional quality of their diet is a key public health action to prevent cardiovascular diseases (CVDs). The modified version of the Food Standard Agency Nutrient Profiling System Dietary Index (FSAm- NPS DI) underpinning the Nutri-Score front-of-pack label has been used in public health strategies to address the deleterious consequences of poor diets. This study aimed to assess the association between the FSAm-NPS DI and some CVD risk factors including body mass index (BMI), waist circumference, plasma glucose levels, triglyceride levels, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, and diastolic and systolic b…
Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial
OBJECTIVE The long-term impact of intentional weight loss on cardiovascular events remains unknown. We describe 12-month changes in body weight and cardiovascular risk factors in PREvención con DIeta MEDiterránea (PREDIMED)-Plus, a trial designed to evaluate the long-term effectiveness of an intensive weight loss lifestyle intervention on primary cardiovascular prevention. RESEARCH DESIGN AND METHODS Overweight/obese adults with metabolic syndrome aged 55–75 years (n = 626) were randomized to an intensive weight loss lifestyle intervention based on an energy-restricted Mediterranean diet, physical activity promotion, and behavioral support (IG) or a control group (CG). The primary and seco…
Total Sugar Intake and Macro and Micronutrients in Children Aged 6-8 Years: The Aniva Study
The objective of this study was to study the association between total sugar intake (TSI) levels of children aged 6-8 years old, nutrient intake and anthropometry. Food and beverage intakes were collected by a prospective three-day recall questionnaire. The 2237 children were distributed into three groups according to TSI percentiles. Mean TSI was 93.77 ±
A Mediterranean Diet Rich in Extra-Virgin Olive Oil Is Associated with a Reduced Prevalence of Nonalcoholic Fatty Liver Disease in Older Individuals at High Cardiovascular Risk
Los autores de este trabajo forman parte de PREDIMED study investigators. Son los siguientes: Principales: Xavier Pintó, Marta Fanlo-Maresma, Emili Corbella, Xavier Corbella, M Teresa Mitjavila, Juan J Moreno, Rosa Casas, Ramon Estruch, Dolores Corella, Mònica Bulló, Miguel Ruiz-Canela, Olga Castañer, J Alfredo Martinez, Emilio Ros, PREDIMED Study Investigators. PREDIMED Study investigators: Estruch R, Martínez-González MA, Corella D, Fitó M, Ros E, Salas-Salvadó J, Arós F, Aldamiz-Echevarría M, Alonso-Gómez AM, Berjón J, Forga L, Gállego J, García-Layana A, Larrauri A, Portu-Zapirain J, Timiraos J, Ros E, Covas MI, Martínez-González MA, Salas-Salvadó J, Pérez-Heras A, Serra-Mir M, Pi-Sunye…
Should we recommend reductions in saturated fat intake or in red/processed meat consumption? The SUN prospective cohort study
Summary Background & aims While most studies have shown increased mortality associated with excessive red/processed meat consumption, the association of saturated fatty acids (SFA) intake with mortality is less homogeneous. We aimed to prospectively assess the association of both, meat consumption (red, processed, red + processed, and total) and SFA intake, with the risk of all-cause death. Methods We assessed 18,540 participants of the SUN (Seguimiento Universidad de Navarra) cohort, followed-up for a mean of 9.5 years. A validated 136-item FFQ was administered at baseline. We used Cox models adjusted for potential confounders. Results We observed 255 deaths during 176,916 person-years of …
Fast food consumption and gestational diabetes incidence in the SUN project.
Background: Gestational diabetes prevalence is increasing, mostly because obesity among women of reproductive age is continuously escalating. We aimed to investigate the incidence of gestational diabetes according to the consumption of fast food in a cohort of university graduates. Methods: The prospective dynamic ‘‘Seguimiento Universidad de Navarra’’ (SUN) cohort included data of 3,048 women initially free of diabetes or previous gestational diabetes who reported at least one pregnancy between December 1999 and March 2011. Fast food consumption was assessed through a validated 136-item semi-quantitative food frequency questionnaire. Fast food was defined as the consumption of hamburgers, …
Similar prediction of total mortality, diabetes incidence and cardiovascular events using relative- and absolute-component Mediterranean diet score: the SUN cohort.
Abstract Background and Aim Accumulated evidence supports the effectiveness of Mediterranean-type diets (MeDiet) in reducing mortality and preventing several chronic diseases. Widely used scores to assess adherence to MeDiet are based on specific sample characteristics; alternatively, they might be built according to absolute/normative cut-off points for the consumption of specific food groups (pre-defined servings/day or/week). The aim of this study was to compare sample-specific MeDiet adherence scores (MDS) versus absolute-normative scores (Mediterranean Diet Adherence Screener – MEDAS) on their association with macronutrient intake, total mortality and incidence of chronic diseases. Des…
Food policies to prevent obesity and the main non-transmissible diseases in Spain: where there's a will there's a way
Introducción: En España, un tercio de los menores y dos tercios de los adultos padecen exceso de peso, una condición que genera un sobre coste médico directo de 2000 millones de euros. El entorno alimentario obesogénico causa obesidad al promover el consumo de bebidas azucaradas y de alimentos ultraprocesados. Por ello, proponemos cinco políticas prioritarias con el PODER de revertir la epidemia de obesidad y de enfermedades no transmisibles asociadas a ella, mediante la creación de entornos alimentarios saludables.El PODER de las políticas alimentarias: P (Publicidad): regulación de la publicidad de alimentos y bebidas no saludables dirigida a menores por todos los medios y prohibición de …
Association of a dietary score with incident type 2 Diabetes: the dietary-based diabetes-risk score (DDS)
Background Strong evidence supports that dietary modifications may decrease incident type 2 diabetes mellitus (T2DM). Numerous diabetes risk models/scores have been developed, but most do not rely specifically on dietary variables or do not fully capture the overall dietary pattern. We prospectively assessed the association of a dietary-based diabetes-risk score (DDS), which integrates optimal food patterns, with the risk of developing T2DM in the SUN (“Seguimiento Universidad de Navarra”) longitudinal study. Methods We assessed 17,292 participants initially free of diabetes, followed-up for a mean of 9.2 years. A validated 136-item FFQ was administered at baseline. Taking into account prev…
Dietary fiber intake and mortality in a Mediterranean population: the “Seguimiento Universidad de Navarra” (SUN) project
Purpose To prospectively assess the association of dietary fiber intake (from different dietary sources) with all-cause mor-tality in a Mediterranean cohort. Methods We assessed 19,703 participants of the SUN (Seguimiento Universidad de Navarra) cohort (mean follow-up: 10.1 years). A validated 136-item FFQ was administered at baseline. We used Cox proportional hazards models adjusted for multiple socio-demographic, anthropometric, lifestyle factors, and prevalent conditions at baseline. Results We observed 323 deaths during 198,341 person-years of follow-up. A significantly inverse linear trend in Cox models was observed for the association of total dietary fiber intake and all-cause mortal…
Disentangling nutrition facts from fiction : towards healthy and sustainable consumption in industrialized societies
Over the last centuries, in the context of industrialization, globalization and urbanization, profound dietary changes have occurred. Ubiquitous access to cheap, readily available and highly palatable unhealthy products, together with aggressive marketing that forcefully impacts social norms, have led to overconsumption of energy-dense, nutrient-poor foods. This has not only been associated with a higher prevalence of obesity and diet-related non-communicable diseases, but also with detrimental effects on the world’s natural resources. Broader and braver public health measures favoring the availability and affordability of healthy, minimally processed foods should be implemented in conjunct…
Mediterranean diet and quality of life: Baseline cross-sectional analysis of the PREDIMED-PLUS trial
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…
Frequent Consumption of Sugar- and Artificially Sweetened Beverages and Natural and Bottled Fruit Juices Is Associated with an Increased Risk of Metabolic Syndrome in a Mediterranean Population at High Cardiovascular Disease Risk.
Background: The relation between the consumption of sweetened beverages and metabolic syndrome (MetS) is controversial. Objective: This analysis evaluated the associations between intakes of sugar-sweetened beverages (SSBs), artificially sweetened beverages, and natural and bottled fruit juices and the incidence of MetS in elderly individuals at high risk of cardiovascular disease (CVD) and without MetS at baseline. Methods: We prospectively examined 1868 participants free of MetS at baseline from the PREDIMED (PREvención con DIeta MEDiterránea) study. MetS was defined by using the updated harmonized criteria of the International Diabetes Federation, the American Heart Association, and Nati…
Use of Different Food Classification Systems to Assess the Association between Ultra-Processed Food Consumption and Cardiometabolic Health in an Elderly Population with Metabolic Syndrome (PREDIMED-Plus Cohort)
The PREDIMED-Plus trial was supported by the European Research Council (Advanced Research grant 2014–2019; agreement #340918; granted to M.Á.M.-G.); the official Spanish institutions for funding scientific biomedical research, CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN) and Instituto de Salud Carlos III (ISCIII) through the Fondo de Investigación para la Salud (FIS) which is co-funded by the European Regional Development Fund (coordinated FIS projects led by J.S-S. and J.V., including the following projects: PI13/00673, PI13/00492, PI13/00272, PI13/01123, PI13/00462, PI13/00233, PI13/02184, PI13/00728, PI13/01090, PI13/01056, PI14/01722, PI14/00636, PI14/00618, PI14/00696, PI…
Association between dietary and beverage consumption patterns in the SUN (Seguimiento Universidad de Navarra) cohort study.
Objective: The objective of the present study was to determine the dietary patterns of a Mediterranean cohort and relate them to the observed patterns of beverage consumption. Design: Prospective cohort study. Dietary habits were assessed with a semiquantitative FFQ validated in Spain. A principal components factor analysis was used to identify dietary patterns and to classify subjects according to their adherence to these patterns. The association between adherence to each dietary pattern and beverage consumption was assessed cross-sectionally. In a longitudinal analysis (2-year follow-up), the relationship between adherence to the baseline dietary patterns and the likelihood of changing a…
The role of lifestyle behaviour on the risk of hypertension in the SUN cohort: The hypertension preventive score
Lifestyles may influence the risk of hypertension. Our objective was to assess the association between a healthy-lifestyle score and the incidence of hypertension. The SUN Project is a dynamic, prospective cohort of Spanish university graduates (1999-2014). Among 14,057 participants initially free of hypertension, we assessed the influence of lifestyle-related factors based on a 10-item score that we previously reported to be associated with lower risk of major cardiovascular events. However, we focused on factors related to hypertension risk according to previous scientific evidence and international clinical guidelines and constructed a 6-item score including: no smoking, moderate-to-high…
Association of the Dietary-Based Diabetes-Risk Score (DDS) with the risk of gestational diabetes mellitus in the Seguimiento Universidad de Navarra (SUN) project
AbstractIt is crucial to identify people at risk for type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM) to implement preventive interventions in order to address these pandemics. A simple score exclusively based on dietary components, the Dietary-Based Diabetes-Risk Score (DDS) showed a strong inverse association with incident T2DM. The objective was to assess the association between DDS and the risk of GDM in a cohort of Spanish university graduates. The ‘Seguimiento Universidad de Navarra’ project is a prospective and dynamic cohort which included data of 3455 women who notified pregnancies between 1999 and 2012. The diagnosis of GDM is self-reported and further confi…
Alcohol intake, wine consumption and the development of depression: the PREDIMED study
Abstract 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…
Total polyphenol intake, polyphenol subtypes and incidence of cardiovascular disease: The SUN cohort study.
Abstract Background and aims Polyphenol-rich diets have been associated with reduced risk of cardiovascular disease (CVD). However, few prospective epidemiological studies have examined the relationship between classes of ingested polyphenols and risk of CVD. Our aim was to evaluate the association between polyphenol intake and risk of major cardiovascular events in a prospective Spanish cohort. Methods and results We included 17,065 university graduates (60.7% women, mean age: 37.2 years, age range: 20–89) followed-up for a mean of 10.1 years. Polyphenol intake was assessed at baseline using a validated semi-quantitative 136-item food frequency questionnaire and matching food consumption d…
Dietary inflammatory index and all-cause mortality in large cohorts: The SUN and PREDIMED studies
[Background]: Inflammation is known to be related to the leading causes of death including cardiovascular disease, several types of cancer, obesity, type 2 diabetes, depression-suicide and other chronic diseases. In the context of whole dietary patterns, the Dietary Inflammatory Index (DII®) was developed to appraise the inflammatory potential of the diet. [Objective]: We prospectively assessed the association between DII scores and all-cause mortality in two large Spanish cohorts and valuated the consistency of findings across these two cohorts and results published based on other cohorts.
Obesity indexes and total mortality among elderly subjects at high cardiovascular risk: The PREDIMED study
Background: Different indexes of regional adiposity have been proposed for identifying persons at higher risk of death. Studies specifically assessing these indexes in large cohorts are scarce. It would also be interesting to know whether a dietary intervention may counterbalance the adverse effects of adiposity on mortality. Methods: We assessed the association of four different anthropometric indexes (waist-to-height ratio (WHtR), waist circumference (WC), body mass index (BMI) and height) with all-cause mortality in 7447 participants at high cardiovascular risk from the PREDIMED trial. Forty three percent of them were men (55 to 80 years) and 57% were women (60 to 80 years). All of them …