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Se abordan las razones que motivan que los resultados de la investigación realizada sobre poblaciones hospitalarias en ocasiones no sea consistente con la practicada en la comunidad. En la base de las diferencias se encuentran el proceso de selección de los pacientes y la recogida de datos por la historia clínica (su falta de uniformidad y el tratamiento de los «no consta»). Se estructura la razón de las discrepancias en función del tipo de pregunta de investigación: frecuencia, diagnóstico, etiología, pronóstico y tratamiento-prevención. Es el proceso de selección el que justifica las diferencias en frecuencia y pronóstico. En relación con el diagnóstico, las discrepancias se deben a la prevalencia de la enfermedad. En el estudio de asociaciones de causalidad ciertos errores son más frecuentes en los estudios hospitalarios, como los sesgos de detección, protopático (ambos exageran la asociación), y el de inclusión (reduce la asociación). Se analizan ejemplos publicados de cada una de ellas. En relación con el tratamiento-prevención, los problemas son sobre todo de validez externa, ya que la metodología del ensayo clínico previene las amenazas a la validez interna; se analiza con un ejemplo de valoración de la eficacia vacunal en pacientes y población sana. La frecuencia de citación de los sesgos se midió en una búsqueda en Medline; en los estudios hospitalarios se mencionó con más frecuencia el sesgo de detección ([RR] = 2,71; intervalo de confianza [IC] del 95%, 1,69-4,37) y el sesgo de confusión por indicación (RR = 1,76; IC del 95%, 0,90-3,42). Por último, se da una serie de recomendaciones destinadas a aumentar la validez de los estudios realizados en el medio hospitalario.

Objective: To estimate the environmental impact of a dietary intervention based on an energy-reduced Mediterranean diet (MedDiet) after one year of follow-up., Methods: Baseline and 1-year follow-up data were used for 5800 participants aged 55-75 years with metabolic syndrome in the PREDIMED-Plus study. Food intake was estimated through a validated semiquantitative food consumption frequency questionnaire, and adherence to the MedDiet was estimated through the Diet Score. Using the EAT-Lancet Commission tables we assessed the influence of dietary intake on environmental impact (through five indicators: greenhouse gas emissions (GHG), land use, energy used, acidification and potential eutrophication). Using multivariable linear regression models, the association between the intervention and changes in each of the environmental factors was assessed. Mediation analyses were carried out to estimate to what extent changes in each of 2 components of the intervention, namely adherence to the MedDiet and caloric reduction, were responsible for the observed reductions in environmental impact., Results: We observed a significant reduction in the intervention group compared to the control group in acidification levels (-13.3 vs. -9.9 g SO2-eq), eutrophication (-5.4 vs. -4.0 g PO4-eq) and land use (-2.7 vs. -1.8 m2). Adherence to the MedDiet partially mediated the association between intervention and reduction of acidification by 15 %, eutrophication by 10 % and land use by 10 %. Caloric reduction partially mediated the association with the same factors by 55 %, 51 % and 38 % respectively. In addition, adherence to the MedDiet fully mediated the association between intervention and reduction in GHG emissions by 56 % and energy use by 53 %., Conclusions: A nutritional intervention based on consumption of an energy-reduced MedDiet for one year was associated with an improvement in different environmental quality parameters., Competing Interests: Declaration of competing interest J.S.-S. reported receiving research support from the Instituto de Salud Carlos III, Ministerio de Educación y Ciencia, the European Commission, the USA National Institutes of Health; receiving consulting fees or travel expenses from Eroski Foundation and Instituto Danone, receiving nonfinancial support from Hojiblanca, Patrimonio Comunal Olivarero, the California Almond Board of California, Pistachio Growers and Borges S.A; serving on the board of and receiving grant support through his institution from the International Nut and Dried Foundation and the Eroski Foundation; and personal fees from Instituto Danone Spain; Serving in the Board of Danone Institute International. D·C. reported receiving grants from Instituto de Salud Carlos III. R.E. reported receiving grants from Instituto de Salud Carlos III, Fundación Dieta Meditarránea and Cerveza y Salud and olive oil for the trial from Fundación Patrimonio Comunal Olivarero and personal fees from Brewers of Europe, Fundación Cerveza y Salud, Interprofesional del Aceite de Oliva, Instituto Cervantes in Albuquerque, Milano and Tokyo, Pernod Ricard, Fundación Dieta Mediterránea (Spain), Wine and Culinary International Forum and Lilly Laboratories; nonfinancial support from Sociedad Española de Nutrición and Fundación Bosch y Gimpera; and grants from Uriach Laboratories. The rest of the authors have declared that no competing interests exist. The funders had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: This article aims to estimate the differences in environmental impact (greenhouse gas [GHG] emissions, land use, energy used, acidification and potential eutrophication) after one year of promoting a Mediterranean diet (MD)., Methods: Baseline and 1-year follow-up data from 5800 participants in the PREDIMED-Plus study were used. Each participant's food intake was estimated using validated semi-quantitative food frequency questionnaires, and the adherence to MD using the Dietary Score. The influence of diet on environmental impact was assessed through the EAT-Lancet Commission tables. The influence of diet on environmental impact was assessed through the EAT-Lancet Commission tables. The association between MD adherence and its environmental impact was calculated using adjusted multivariate linear regression models., Results: After one year of intervention, the kcal/day consumed was significantly reduced (-125,1 kcal/day), adherence to a MD pattern was improved (+0,9) and the environmental impact due to the diet was significantly reduced (GHG: -361 g/CO2-eq; Acidification:-11,5 g SO2-eq; Eutrophication:-4,7 g PO4-eq; Energy use:-842,7 kJ; and Land use:-2,2 m2). Higher adherence to MD (high vs. low) was significantly associated with lower environmental impact both at baseline and one year follow-up. Meat products had the greatest environmental impact in all the factors analysed, both at baseline and at one-year follow-up, in spite of the reduction observed in their consumption., Conclusions: A program promoting a MD, after one year of intervention, significantly reduced the environmental impact in all the factors analysed. Meat products had the greatest environmental impact in all the dimensions analysed., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Dietary patterns can produce an environmental impact. Changes in people's diet, such as the increased consumption of ultra-processed food (UPF) can not only influence human health but also environment sustainability., Objectives: Assessment of the impact of 2-year changes in UPF consumption on greenhouse gas emissions and water, energy and land use., Design: A 2-year longitudinal study after a dietary intervention including 5879 participants from a Southern European population between the ages of 55-75 years with metabolic syndrome., Methods: Food intake was assessed using a validated 143-item food frequency questionnaire, which allowed classifying foods according to the NOVA system. In addition, sociodemographic data, Mediterranean diet adherence, and physical activity were obtained from validated questionnaires. Greenhouse gas emissions, water, energy and land use were calculated by means of the Agribalyse® 3.0.1 database of environmental impact indicators for food items. Changes in UPF consumption during a 2-year period were analyzed. Statistical analyses were conducted using computed General Linear Models., Results: Participants with major reductions in their UPF consumption reduced their impact by -0.6 kg of CO 2 eq and -5.3 MJ of energy. Water use was the only factor that increased as the percentage of UPF was reduced., Conclusions: Low consumption of ultra-processed foods may contribute to environmental sustainability. The processing level of the consumed food should be considered not only for nutritional advice on health but also for environmental protection., Trial Registration: ISRCTN, ISRCTN89898870. Registered 05 September 2013, http://www.isrctn.com/ISRCTN89898870., Competing Interests: Declaration of competing interest This work was supported by 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 (six coordinated FIS projects leaded by JS-S and JVi, 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, PI14/01206, PI14/01919, PI14/00853, PI14/01374, PI14/00972, PI14/00728, PI14/01471, PI16/00473, PI16/00662, PI16/01873, PI16/01094, PI16/00501, PI16/00533, PI16/00381, PI16/00366, PI16/01522, PI16/01120, PI17/00764, PI17/01183, PI17/00855, PI17/01347, PI17/00525, PI17/01827, PI17/00532, PI17/00215, PI17/01441, PI17/00508, PI17/01732, PI17/00926, PI19/00957, PI19/00386, PI19/00309, PI19/01032, PI19/00576, PI19/00017, PI19/01226, PI19/00781, PI19/01560, PI19/01332, PI20/01802, PI20/00138, PI20/01532, PI20/00456, PI20/00339, PI20/00557, PI20/00886, PI20/01158); the Especial Action Project entitled: Implementación y evaluación de una intervención intensiva sobre la actividad física Cohorte PREDIMED-Plus grant to JS-S; the European Research Council (Advanced Research Grant 2014–2019; agreement #340918) granted to MÁM-G.; the Recercaixa (number 2013ACUP00194) grant to JS-S; grants from the Consejería de Salud de la Junta de Andalucía (PI0458/2013, PS0358/2016, PI0137/2018); the PROMETEO/2017/017 and the AICO/2021/347 grants from the Generalitat Valenciana; the SEMERGEN grant. J.S-S is partially supported by ICREA under the ICREA Academia programme. C.B. was granted by Juan de la Cierva grant. P.M.G. was granted by the Specialist Postdoctoral program of the Consejería de Salud y Familias, Junta de Andalucía (Spain). None of the funding sources took part in the design, collection, analysis, interpretation of the data, or writing the report, or in the decision to submit the manuscript for publication. J.S.-S. reported receiving research support from the Instituto de Salud Carlos III, Ministerio de Educación y Ciencia, the European Commission, the USA National Institutes of Health; receiving consulting fees or travel expenses from Eroski Foundation and Instituto Danone, receiving nonfinancial support from Hojiblanca, Patrimonio Comunal Olivarero, the California Almond Board of California, Pistachio Growers and Borges S.A; serving on the board of and receiving grant support through his institution from the International Nut and Dried Foundation and the Eroski Foundation; and personal fees from Instituto Danone Spain; Serving in the Board of Danone Institute International. D.C. reported receiving grants from Instituto de Salud Carlos III. R.E. reported receiving grants from Instituto de Salud Carlos III, Fundación Dieta Meditarránea and Cerveza y Salud and olive oil for the trial from Fundación Patrimonio Comunal Olivarero and personal fees from Brewers of Europe, Fundación Cerveza y Salud, Interprofesional del Aceite de Oliva, Instituto Cervantes in Albuquerque, Milano and Tokyo, Pernod Ricard, Fundación Dieta Mediterránea (Spain), Wine and Culinary International Forum and Lilly Laboratories; non-financial support from Sociedad Española de Nutrición and Fundación Bosch y Gimpera; and grants from Uriach Laboratories. The rest of the authors have declared that no competing interests exist. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Tree nuts and peanuts (henceforth, nuts) are nutrient-dense foods rich in neuroprotective components; thus, their consumption could benefit cognitive health. However, evidence to date is limited and inconsistent regarding the potential benefits of nuts for cognitive function., Objective: To prospectively evaluate the association between nut consumption and 2-y changes in cognitive performance in older adults at cognitive decline risk., Methods: A total of 6,630 participants aged 55 to 75 y (mean age 65.0±4.9 y, 48.4% women) with overweight/obesity and metabolic syndrome completed a validated semi-quantitative food frequency questionnaire and a comprehensive battery of neuropsychological tests at baseline and a 2-y follow-up. Composite cognitive scores were used to assess global, general, attention, and executive function domains. Nut consumption was categorized as <1, ≥1 to <3, ≥3 to <7, and ≥7 servings/wk (1 serving=30 g). Multivariable-adjusted linear regression models were fitted to assess associations between baseline nut consumption and 2-y cognitive changes., Results: Nut consumption was positively associated with 2-y changes in general cognitive function (P-trend <0.001). Compared with participants consuming <1 serving/wk of nuts, those categorized as consuming ≥3 to <7 and ≥7 servings/wk showed more favorable changes in general cognitive performance (β z-score [95% CI] = 0.06 [0.00,0.12] and 0.13 [0.06,0.20], respectively). No significant changes were observed in the multivariable-adjusted models for other cognitive domains assessed., Conclusion: Frequent nut consumption was associated with a smaller decline in general cognitive performance over 2 y in older adults at risk of cognitive decline. Randomized clinical trials to verify our findings are warranted., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background and Aims: The association between changes in ultra-processed food (UPF) consumption and cardiometabolic risk (CMR) factors remains understudied. We evaluated the association between changes in UPF consumption over 12 months of follow-up and changes in CMR factors in adults diagnosed with metabolic syndrome., Methods: We analysed data from 5373 adults (aged 55-75 years) participating in the PREDIMED-Plus trial. Diet was evaluated at baseline, 6- and 12-month visits using a validated food frequency questionnaire, and UPF consumption (in grams/day and percentage of total daily dietary intake in grams) was categorized based on NOVA classification. We used mixed-effects linear models with repeated measurements at baseline, 6 and 12 months of follow-up to assess the associations between changes in UPF consumption and changes in CMR factors adjusting for sociodemographic and lifestyles variables., Results: In multivariable-adjusted models, when comparing the highest versus the lowest quartile of UPF consumption, positive associations were found for several CMR factors: weight (kg, β = 1.09; 95% confidence interval 0.91 to 1.26); BMI (kg/m 2 , β = 0.39; 0.33 to 0.46); waist circumference (cm, β = 1.03; 0.81 to 1.26); diastolic blood pressure (mm Hg, β = 0.67; 0.29 to 1.06); fasting blood glucose (mg/dl, β = 1.66; 0.61 to 2.70); HbA1c (%, β = 0.04; 0.01 to 0.07); triglycerides (mg/dl, β = 6.79; 3.66 to 9.91) and triglycerides and glucose index (β = 0.06; 0.04 to 0.08)., Conclusions: Higher UPF consumption was associated with adverse evolution in objectively measured CMR factors after 12 months of follow-up in adults with metabolic syndrome. Further research is needed to explore whether these changes persist for longer periods., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Background and Aims: Total fruit consumption is important for cardiovascular disease prevention, but also the variety and form in which is consumed. The aim of the study was to assess the associations between total fruit, subgroups of fruits based on their color and fruit juices consumption with different cardiometabolic parameters., Methods and Results: A total of 6633 elderly participants (aged 55-75 years) with metabolic syndrome from the PREDIMED-Plus study were included in this analysis. Fruit and fruit juice consumption was assessed using a food frequency questionnaire. Linear regression models were fitted to evaluate the association between exposure variables (total fruit, subgroups based on the color, and fruit juices) and different cardiometabolic risk factors. Individuals in the highest category of total fruit consumption (≥3 servings/d) had lower waist circumference (WC) (β = -1.04 cm; 95%CI:-1.81, -0.26), fasting glucose levels (β = -2.41 mg/dL; 95%CI(-4.19, -0.63) and LDL-cholesterol (β = -4.11 mg/dL; 95%CI:-6.93, -1.36), but, unexpectedly, higher systolic blood pressure (BP) (β = 1.84 mmHg; 95%CI: 0.37, 3.30) and diastolic BP (β = 1.69 mmHg; 95%CI:0.83, 2.56) when compared to those in the lowest category of consumption (<1 servings/d). Participants consuming ≥1 serving/day of total fruit juice had lower WC (β = -0.92 cm; 95%CI:-1.56, -0.27) and glucose levels (β = -1.59 mg/dL; 95%CI:-2.95, -0.23) than those consuming <1 serving/month. The associations with cardiometabolic risk factors differed according to the color of fruits., Conclusion: Fruit consumption is associated with several cardiometabolic risk factors in Mediterranean elders with metabolic syndrome. The associations regarding BP levels could be attributed, at least partially, to reverse causality bias inherent to the cross-sectional design of the study., Competing Interests: Conflict of interest The authors declare that they have no conflict of interest related to this article., (Copyright © 2021 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Background & Aims: The Portfolio and Dietary Approaches to Stop Hypertension (DASH) diets have been shown to lower cardiometabolic risk factors in randomized controlled trials (RCTs). However, the Portfolio diet has only been assessed in RCTs of hyperlipidemic patients. Therefore, to assess the Portfolio diet in a population with metabolic syndrome (MetS), we conducted a longitudinal analysis of one-year data of changes in the Portfolio and DASH diet scores and their association with cardiometabolic risk factors in Prevención con Dieta Mediterránea (PREDIMED)-Plus trial., Methods: PREDIMED-Plus is an ongoing clinical trial (Trial registration: ISRCTN89898) conducted in Spain that includes 6874 older participants (mean age 65 y, 48% women) with overweight/obesity fulfilling at least three criteria for MetS. Data for this analysis were collected at baseline, six months and one year. Adherence to the Portfolio and DASH diet scores were derived from a validated 143-item food frequency questionnaire. We used linear mixed models to examine the associations of 1-SD increase and quartile changes in the diet scores with concomitant changes in cardiometabolic risk factors., Results: After adjusting for several potential confounders, a 1-SD increase in the Portfolio diet score was significantly associated with lower HbA1c (β [95% CI]: -0.02% [-0.02, -0.01], P < 0.001), fasting glucose (-0.47 mg/dL [-0.83, -0.11], P = 0.01), triglycerides (-1.29 mg/dL [-2.31, -0.28], P = 0.01), waist circumference (WC) (-0.51 cm [-0.59, -0.43], P < 0.001), and body mass index (BMI) (-0.17 kg/m 2 [-0.19, -0.15], P < 0.001). A 1-SD increase in the DASH diet score was significantly associated with lower HbA1c (-0.03% [-0.04, -0.02], P < 0.001), glucose (-0.84 mg/dL [-1.18, -0.51], P < 0.001), triglycerides (-3.38 mg/dL [-4.37, -2.38], P < 0.001), non-HDL-cholesterol (-0.47 mg/dL [-0.91, -0.04], P = 0.03), WC (-0.69 cm [-0.76, -0.60 cm], P < 0.001), BMI (-0.25 kg/m 2 [-0.28, -0.26 kg/m 2 ], P < 0.001), systolic blood pressure (-0.57 mmHg [-0.81, -0.32 mmHg], P < 0.001), diastolic blood pressure (-0.15 mmHg [-0.29, -0.01 mmHg], P = 0.03), and with higher HDL-cholesterol (0.21 mg/dL [0.09, 0.34 mg/dL, P = 0.001]). Similar associations were seen when both diet scores were assessed as quartiles, comparing extreme categories of adherence., Conclusions: Among older adults at high cardiovascular risk with MetS, greater adherence to the Portfolio and DASH diets showed significant favourable prospective associations with several clinically relevant cardiometabolic risk factors. Both diets are likely beneficial for cardiometabolic risk reduction., Competing Interests: Conflict of interest AJG has done consulting work for SoLo GI Nutrition and has received an honorarium from the Soy Nutrition Institute. CWCK has received grants or research support from the Advanced Food Materials Network, Agriculture and Agri-Foods Canada (AAFC), Almond Board of California, American Peanut Council, Barilla, Canadian Institutes of Health Research (CIHR), Canola Council of Canada, International Nut and Dried Fruit Council, International Tree Nut Council Research and Education Foundation, Loblaw Brands Ltd, Pulse Canada and Unilever. He has received in-kind research support from the Almond Board of California, American Peanut Council, Barilla, California Walnut Commission, Kellogg Canada, Loblaw Companies, Nutrartis, Quaker (PepsiCo), Primo, Unico, Unilever, WhiteWave Foods/Danone. He has received travel support and/or honoraria from the American Peanut Council, Barilla, California Walnut Commission, Canola Council of Canada, General Mills, International Nut and Dried Fruit Council, International Pasta Organization, Lantmannen, Loblaw Brands Ltd, Nutrition Foundation of Italy, Oldways Preservation Trust, Paramount Farms, Peanut Institute, Pulse Canada, Sun-Maid, Tate & Lyle, Unilever and White Wave Foods/Danone. He has served on the scientific advisory board for the International Tree Nut Council, International Pasta Organization, McCormick Science Institute and Oldways Preservation Trust. He is a member of the International Carbohydrate Quality Consortium (ICQC), Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD), is on the Clinical Practice Guidelines Expert Committee for Nutrition Therapy of the EASD and is a Director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. DJAJ has received research grants from Loblaw Companies Ltd., the Almond Board of California, Soy Nutrition Institute (SNI), and the Canadian Institutes of Health Research (CIHR). He has received in-kind supplies for trials as a research support from the Almond board of California, Walnut Council of California, American Peanut Council, Barilla, Unilever, Unico, Primo, Loblaw Companies, Quaker (Pepsico), Pristine Gourmet, Bunge Limited, Kellogg Canada, WhiteWave Foods. He has been on the speaker's panel, served on the scientific advisory board and/or received travel support and/or honoraria from the Loblaw Companies Ltd, Diet Quality Photo Navigation (DQPN), Better Therapeutics (FareWell), Verywell, True Health Initiative (THI), Heali AI Corp, Institute of Food Technologists (IFT), Soy Nutrition Institute (SNI), Herbalife Nutrition Institute (HNI), Herbalife International, Pacific Health Laboratories, Nutritional Fundamentals for Health (NFH), the Soy Foods Association of North America, the Nutrition Foundation of Italy (NFI), the Toronto Knowledge Translation Group (St. Michael's Hospital), the Canadian College of Naturopathic Medicine, The Hospital for Sick Children, the Canadian Nutrition Society (CNS), and the American Society of Nutrition (ASN). He is a member of the International Carbohydrate Quality Consortium (ICQC). His wife, Alexandra L Jenkins, is a director and partner of INQUIS Clinical Research for the Food Industry, his 2 daughters, Wendy Jenkins and Amy Jenkins, have published a vegetarian book that promotes the use of the low glycemic index plant foods advocated here, The Portfolio Diet for Cardiovascular Risk Reduction (Academic Press/Elsevier 2020 ISBN:978-0-12-810510-8)and his sister, Caroline Brydson, received funding through a grant from the St. Michael's Hospital Foundation to develop a cookbook for one of his studies. ER has received research funding through his institution from the California Walnut Commission, Folsom, CA, USA; was a paid member of its Health Research Advisory Group; and is a nonpaid member of its Scientific Advisory Council. He has also received research support through his institution from Alexion and serves on its Scientific Advisory board, received fees for scientific presentations and travel support from Danone, and travel support from the International Nut Council. JS-S serves on the board of (and receives grant support through his institution from) the International Nut and Dried Fruit Council and the Eroski Foundation. He also serves on the Executive Committee of the Instituto Danone, Spain, and on the Scientific Committee of the Danone International Institute. He has received research support from the Patrimonio Comunal Olivarero, Spain, and Borges S.A., Spain. He receives consulting fees or travel expenses from Danone, the Eroski Foundation, the Instituto Danone Spain, and Abbot Laboratories. RE reports grants from Cerveza y Salud, Spain, Fundacion Dieta Mediterranea, Spain and Interprofesional del Vino, Spain. Also, personal fees for given lectures from Brewers of Europe, Belgium, Fundacion Cerveza y Salud, Spain, Pernaud-Ricard, Mexico, Instituto Cervantes, Alburquerque, USA; Instituto Cervantes, Milan, Italy, Instituto Cervantes, Tokyo, Japan, Lilly Laboratories, Spain, and Wine and Culinary International Forum, Spain, and non-financial support to organize a National Congress on Nutrition. Also feeding trials with product from Grand Fountain and Uriach Laboratories, Spain. JLS has received research support from the Canadian Foundation for Innovation, Ontario Research Fund, Province of Ontario Ministry of Research and Innovation and Science, Canadian Institutes of health Research (CIHR), Diabetes Canada, PSI Foundation, Banting and Best Diabetes Centre (BBDC), American Society for Nutrition (ASN), INC International Nut and Dried Fruit Council Foundation, National Dried Fruit Trade Association, National Honey Board, International Life Sciences Institute (ILSI), Pulse Canada, Quaker, The Tate and Lyle Nutritional Research Fund at the University of Toronto, The Glycemic Control and Cardiovascular Disease in Type 2 Diabetes Fund at the University of Toronto (a fund established by the Alberta Pulse Growers), and The Nutrition Trialists Fund at the University of Toronto (a fund established by an inaugural donation from the Calorie Control Council). He has received in-kind food donations to support a randomized controlled trial from the Almond Board of California, California Walnut Commission, American Peanut Council, Barilla, Unilever/Upfield, Unico/Primo, Loblaw Companies, Quaker, Kellogg Canada, WhiteWave Foods/Danone, and Nutrartis. He has received travel support, speaker fees and/or honoraria from Diabetes Canada, Dairy Farmers of Canada, FoodMinds LLC, International Sweeteners Association, Nestlé, Pulse Canada, Canadian Society for Endocrinology and Metabolism (CSEM), GI Foundation, Abbott, General Mills, Biofortis, ASN, Northern Ontario School of Medicine, INC Nutrition Research & Education Foundation, European Food Safety Authority (EFSA), Comité Européen des Fabricants de Sucre (CEFS), Nutrition Communications, International Food Information Council (IFIC), Calorie Control Council, and Physicians Committee for Responsible Medicine. He has or has had ad hoc consulting arrangements with Perkins Coie LLP, Tate & Lyle, Wirtschaftliche Vereinigung Zucker e.V., Danone, and Inquis Clinical Research. He is a member of the European Fruit Juice Association Scientific Expert Panel and Soy Nutrition Institute (SNI) Scientific Advisory Committee. He is on the Clinical Practice Guidelines Expert Committees of Diabetes Canada, European Association for the study of Diabetes (EASD), Canadian Cardiovascular Society (CCS), and Obesity Canada. He serves or has served as an unpaid scientific advisor for the Food, Nutrition, and Safety Program (FNSP) and the Technical Committee on Carbohydrates of ILSI North America. He is a member of the International Carbohydrate Quality Consortium (ICQC), Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the EASD, and Director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. His wife is an employee of AB InBev. All other authors declare no conflicts., (Copyright © 2021 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background and Aims: Previous studies, mainly focused on quantity rather than variety, have shown beneficial associations between the amount of fruit and vegetable consumed, diet quality and healthy lifestyle. The aim is to evaluate the association between fruit and vegetable consumption, diet quality and lifestyle in an elderly Mediterranean population, considering both variety and the combination of quantity and variety (QV)., Methods: A cross-sectional analysis of 6647 participants (51.6% of males) was conducted in the framework of the PREDIMED-Plus study. A variety score was created as the sum of vegetables and/or fruits consumed at least once per month using food frequency questionnaires. Dietary Reference Intakes (EAR and IA values) were used to estimate the prevalence of inadequate intake of dietary fiber and micronutrients. Logistic regression models were performed to examine the association between fruit and vegetable consumption and not meeting the DRIs, by tertiles of fruit and vegetable variety and QV categories., Results: Participants with higher fruit and vegetable variety score reported a significant higher intake of fiber, vitamins, minerals and flavonoids and were significantly more likely to be physically active and non-smoker. Besides, higher variety in fruit and vegetable consumption was associated with lower prevalence of having an inadequate intake of fiber [(0.13 (0.11-0.16)], two or more [(0.17 (0.14-0.21)], three or more [(0.15 (0.13-0.18)] and four or more [(0.11 (0.10-0.14)] micronutrients in our participants. Higher quantity and variety in fruit and vegetable consumption was associated with lower prevalence of having an inadequate intake of fiber [(0.05 (0.04-0.06)], two or more [(0.08 (0.06-0.10)], three or more [(0.08 (0.06-0.09)] and four or more [(0.06 (0.05-0.07)] micronutrients., Conclusion: Greater variety in fruit and vegetable intake was associated with better nutrient adequacy, diet quality and healthier lifestyle in an elderly Mediterranean population., Competing Interests: Potential conflicts of interest JS-S serves on the board of (and receives grant support through his institution from) the International Nut and Dried Fruit Council and the Eroski Foundation. He also serves on the Executive Committee of the Instituto Danone, Spain, and on the Scientifc Committee of the Danone International Institute. He has received research support from the Patrimonio Comunal Olivarero, Spain, and Borges S.A., Spain. He receives consulting fees or travel expenses from Danone, the Eroski Foundation, the Instituto Danone, Spain, and Abbot Laboratories. ER has received research funding through his institution from the California Walnut Commission, Folsom, CA, USA; was a paid member of its Health Research Advisory Group; and is a non-paid member of its Scientifc Advisory Council. RE reports grants from Cerveza y Salud, Spain and Fundación Dieta Mediterranea, Spain. Also personal fees for given lectures from Brewers of Europe, Belgium; Fundación Cerveza y Salud, Spain; Pernaud-Ricard, Mexico; Instituto Cervantes, Alburquerque, USA; Instituto Cervantes, Milano, Italy; Instituto Cervantes, Tokio, Japan; Lilly Laboratories, Spain and Wine and Culinary International Forum, Spain and non-financial support to organize a National Congress on Nutrition. Also feeding trials with product from Grand Fountain and Uriach Laboratories, Spain. LL-G, NB-T, NB, MAM-G, AD-L, DC, AG, DR, JV, AMA-G, JW, JAM, LS-M, FT, JL, XP, JAT, JL-M, AB-C, MD-R, PM-M, LD, LA-A, JV, CV, ZV-R, SC, RF, OC, MAZ, LT, MJA, CML, MM, AG-R, RC, AMG-P, JMS-L, EG, PG-S, CL, IA, IS, SE and HS have nothing to declare., (Copyright © 2021 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background & Aims: An inadequate nutrients intake during pregnancy has been related to an increase of having a small for gestational age (SGA) newborn. A diversity dietary (DD) intake could decrease the risk of SGA delivery, providing the adequate nutrient requirements during pregnancy. The aim of this study was to assess the effect of DD on adequate nutrient intake in a sample of Spanish pregnant women, further to investigate their association on SGA delivery., Methods: A matched case-control study of 518 cases and controls of pregnant women was performed in five hospitals in Eastern Andalusia (Spain). Cases were women with a newborn with SGA. Data about demographic characteristics and diet were collected by trained midwives. DD score (DDS) adjusted by total energy intake was gathered through a validated food frequency questionnaire (FFQ). Nutrient inadequacy was defined as an intake below 2/3 of the recommended dietary intake according to dietary recommendations intake (DRI) for pregnant women. The association between DDS and SGA was assessed by logistic regression models with adjustment for confounding factors., Results: The prevalence of nutrient inadequate intake decreased across total DDS quintiles (p < 0.05). Women in higher strata of total DDS presented less SGA risk (aOR = 0.50, C.I. 95%: 0.31, 0.80). According to each DDS component, the consumption of high diversity of dairy products showed a significative protection against the risk of having a SGA newborn (aOR = 0.48, C.I. 95%: 0.32, 0.71)., Conclusions: SGA mothers had higher prevalence of nutritional inadequacies and lower DDS compared to their counterparts. Poor total DDS and less variety of dairy products were associated with higher risk of SGA newborn. Efforts to promote DD during pregnancy need to be strengthened to reduce the prevalence of SGA in Spain., (Copyright © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background & Aims: Few studies have compared micronutrient intake and fulfilment of average requirements (EAR) in non-diabetic, pre-diabetic and diabetic adults at high cardiovascular risk. We assessed these variables in a large sample of participants in the PREDIMED-PLUS randomized trial of primary cardiovascular prevention with diet and physical activity., Design: Baseline assessment of nutritional adequacy in n = 5792 men and women, aged 55-75 years, with overweight/obesity and some metabolic syndrome features., Methods: Participants were categorised as non-diabetic (n = 2390), pre-diabetic (n = 1322) or diabetic (n = 2080) by standard criteria. Food and nutrient intake were assessed using a validated food frequency questionnaire. Micronutrients examined were vitamins B1, B2, B3, B6, B12, A, C, D, E and folic acid; Ca, K, P, Mg, Fe, Se, Cr, Zn, and iodine. The proportion of micronutrient inadequacy was evaluated using the EAR or adequate intake (AI) cut-offs. Diet quality was also determined using a 17-item energy-restricted Mediterranean diet (MedDiet) questionnaire., Results: Compared to non-diabetic participants, those with pre-diabetes had lower intakes of total carbohydrates (CHO) and higher intakes of total fat and saturated fatty acids (SFA) and were more likely to be below EAR for folic, while diabetic participants had lower intakes of total CHO and higher intakes of protein, total fat, monounsaturated fatty acids, SFA and cholesterol and were less likely to be below EAR for vitamins B2, and B6, Ca, Zn and iodine. Diabetic participants disclosed higher adherence to the MedDiet than the other two groups., Conclusions: Older Mediterranean individuals with metabolic syndrome and diabetes had better nutrient adequacy and adherence to the MedDiet than those with pre-diabetes or no diabetes., (Copyright © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background: Overall quality of dietary carbohydrate intake rather than total carbohydrate intake may determine the risk of cardiovascular disease (CVD)., Objective: We examined 6- and 12-mo changes in carbohydrate quality index (CQI) and concurrent changes in several CVD risk factors in a multicenter, randomized, primary-prevention trial (PREDIMED-Plus) based on an intensive weight-loss lifestyle intervention program., Methods: Prospective analysis of 5373 overweight/obese Spanish adults (aged 55-75 y) with metabolic syndrome (MetS). Dietary intake information obtained from a validated 143-item semiquantitative food-frequency questionnaire was used to calculate 6- and 12-mo changes in CQI (categorized in quintiles), based on 4 criteria (total dietary fiber intake, glycemic index, whole grain/total grain ratio, and solid carbohydrate/total carbohydrate ratio). The outcomes were changes in intermediate markers of CVD., Results: During the 12-mo follow-up, the majority of participants improved their CQI by increasing their consumption of fruits, vegetables, legumes, fish, and nuts and decreasing their consumption of refined cereals, added sugars, and sugar-sweetened beverages. After 6 mo, body weight, waist circumference (WC), systolic and diastolic blood pressure (BP), fasting blood glucose, glycated hemoglobin (HbA1c), triglyceride levels, triglycerides and glucose (TyG) index, and TyG-WC decreased across successive quintiles of improvement in the CQI. After 12 mo, improvements were additionally observed for HDL cholesterol and for the ratio of total to HDL cholesterol. Favorable improvements (expressed in common units of SD and 95% CI) for quintile 5 compared with quintile 1 of CQI change were observed for most risk factors, including TyG-WC (SD -0.20; 95% CI -0.26, -0.15), HbA1c (SD -0.16; 95% CI -0.23, -0.10), weight (SD -0.12; 95% CI -0.14, -0.09), systolic BP (SD -0.11; 95% CI -0.19, -0.02) and diastolic BP (SD -0.11; 95% CI -0.19, -0.04)., Conclusions: Improvements in CQI were strongly associated with concurrent favorable CVD risk factor changes maintained over time in overweight/obese adults with MetS. This trial was registered as ISRCTN 89898870., (Copyright © The Author(s) 2019.)

Background & Aims: We investigated whether protein intake (PI) is related to osteoporotic fractures (OP) in the elderly by analyzing vegetable protein intake (VPI), animal protein intake (API), and animal/vegetable protein intake ratio (AVR) and by calcium intake (CaI)., Methods: A 1:1 matched by age and sex case-control study with 167 cases was carried out at the Hospital of Jaen (Spain). Cases were patients aged ≥65 years with a low-energy fracture. Controls were people without previous fractures. Diet was assessed by a food frequency questionnaire. Multivariable analyses were fitted using analysis of covariance (for comparison of adjusted means) and conditional logistic regression (estimating adjusted odds ratios [ORs])., Results: The control-group showed a higher API (p = 0.046) even when CaI was <800 mg/day (p = 0.041). ORs for AVR were 0.68 (0.38-1.19) and 0.38 (0.15-0.98), respectively with a p for trend = 0.046. A PI<15% of the total energy intake showed an OR of 2.86 (1.10-7.43)., Conclusions: Patients with fracture history have lower API suggesting that high API reduce the occurrence of OP in elderly even if CaI is <800 mg/day. A PI<15% of total calories were associated with an increased risk of OP in elderly., (Copyright © 2011 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Purpose: The effects of moderate alcohol drinking on low birth weight are not clear, and conflicting results have been reported. We assessed the influence of different patterns of alcohol drinking during pregnancy on low birth weight., Methods: A case-control study was carried out at the University of Cantabria Hospital, Spain, from 1998 to 2002. Cases (n = 552) were mothers delivering a single newborn weighing less than 2500 g. Controls (n = 1451) were selected from a random sample of all delivering women. Information was obtained from personal interview, clinical charts, and prenatal care records. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Adjustment for potential confounders was made by means of logistic regression., Results: Alcohol consumption of less than 6 g/day decreased the risk for low birth weight (adjusted OR = 0.64; 95% CI, 0.46-0.88). A similar result was obtained for moderate drinkers (<12 g/day) on weekends only. The opposite relationship was observed between alcohol consumption on weekdays of 12 g/day or greater (adjusted OR = 2.67; 95% CI, 1.39-5.12), not observed in those drinking on weekends only. The interaction between alcohol consumption and tobacco smoking was analyzed. Weekday drinkers of 12 g/day or greater showed an increased risk in smokers. Alcohol consumption on weekends only in nonsmokers was inversely related. The influence of alcohol was greater for small-for-gestational-age (SGA) than non-SGA babies., Conclusions: Alcohol consumption of 12 g/day or greater increased the risk for low birth weight, whereas lower consumption during weekends showed the opposite effect (mainly in nonsmokers).

Background: Some observational studies have shown a beneficial effect of dairy consumption on blood pressure, especially in overweight and relatively young (<40 y) persons. However, no results from prospective studies conducted in a free-living population exist that show this association in middle-aged adults., Objective: The aim of the present study was to assess whether total, low-fat, and whole-fat dairy consumption was associated prospectively with the risk of hypertension., Design: This was a prospective study conducted in 5880 university graduates in Spain, aged >20 y in 2000 (mean age: 37 y), free of hypertension and cardiovascular disease at baseline, and followed-up with mailed questionnaires for a median of 27 mo. Dairy consumption was assessed with a previously validated semiquantitative food-frequency questionnaire., Results: One hundred eighty new cases of hypertension were identified. The hazard ratio of hypertension between extreme quintiles of low-fat dairy product consumption was 0.46 (95% CI: 0.26, 0.84; P for trend = 0.02) after adjustment for the main known risk factors for hypertension and several dietary factors. No significant association between whole-fat dairy products or total calcium intake and incident hypertension was seen., Conclusion: In this Mediterranean cohort, low-fat dairy consumption, but not whole-fat dairy consumption, was associated with a lower risk of incident hypertension.

Background and Objective: Survival-agreement plots have been suggested as a new graphical approach to assess agreement in quantitative variables. We propose that survival analytical techniques can complement this method, providing a new analytical insight for agreement., Methods: Two survival-agreement plots are used to detect the bias between to measurements of the same variable. The presence of bias is tested with log-rank test, and its magnitude with Cox regression., Results: An example on C-reactive protein determinations shows how survival analytical methods would be interpreted in the context of assessing agreement., Conclusion: Log-rank test, Cox regression, or other analytical methods could be used to assess agreement in quantitative variables; correct interpretations require good clinical sense.

Objective: Attributable fraction in the exposed and (population) attributable fraction have been extensively used to determine the proportion of cases of a particular disease that can be attributable to any risk factor. Epidemiologists know that these measurements can add up to more than 100%; nevertheless, in a clinical context or in mass media, this characteristic is sometimes misinterpreted. This article provides a way to estimate the contribution of a risk factor in populations., Study Design and Setting: McElduff et al. have suggested a method for estimating the contribution of a risk factor in a person with more than one risk factor. We extend their suggestion to populations where risk factors are mixed in different proportions. We illustrate the usage of this method by enlarging the example provided by them and compare it with the average attributable fraction suggested by Eide and Gefeller., Results: Population attributable fraction can be modified to obtain additivity; therefore, the contribution of a risk factor in populations can be estimated, which would be of interest, for example, in clinical or in court settings., Conclusion: The suggested method and the average attributable fraction provide different results, and would be applicable under different assumptions.

The main objective of this cohort study was to analyze the influence of social factors on the interval from the onset of symptoms to diagnosis in the 217 patients with digestive tract cancer. From the clinical charts, the following information was extracted: date of the beginning of illness, dates of medical attendance, type and date of diagnostic tests, characteristics of the disease (symptoms, stage), and date of treatment. From personal interviews we gathered the data not present in the clinical chart: sociodemographic data, information about other underlying diseases, and variables related to lifestyle. The time periods considered were from onset of symptoms to initial consultation (S-C); from initial consultation to hospital admission (C-H); and from hospital admission to diagnosis (H-D). The information on hospital admission, diagnosis, and treatment was prospectively gathered, whereas data before hospitalization were assessed retrospectively. For statistical analysis, we used Kruskal-Wallis test and Cox regression. Pain was the only predictor associated with a shorter S-C period. Hemorrhage, number of symptoms, and hospital consultation significantly shortened the interval C-H. Both hemorrhage and pain, and an initial visit at private primary care were the independent predictors that decreased the period H-D. In conclusion, sociodemographic factors did not influence healthcare attendance.

The increase in lung cancer (LC) mortality can produce a decrease in mortality from other causes, including ischemic heart disease (IHD). This problem (called the competing risks problem) has been addressed usually assuming independence between the competing causes of death. Our purpose is to show that assuming dependence of causes of death allows obtaining a better estimation of cumulative mortality. We use a clinical epidemiological example on the impact of AIDS in liver function failure in a cohort of drug users. The competing effect under dependence is 47% higher than under independence. This result is compared with a population-based example on LC and IHD mortalities in Spanish people in 1992. LC and IHD share tobacco smoking as a common risk factor, so independence cannot be assumed. Under the independence assumption, both life expectancy and number of deaths from IHD are underestimated. The difference is small compared to the model computed under dependence and it occurs mainly in the elderly (0.3% more deaths in people aged 70 and over).

We examined the possible involvement of polymorphisms of the presenilin 1 (PS1) and presenilin 2 (PS2) genes in the risk for sporadic Alzheimer's disease (AD), either through an independent effect or through interaction with the existing apolipoprotein E (ApoE) risk, in 211 AD cases and 188 age-matched control subjects. No significant differences were obtained in any of the comparisons relating the effect of the PS1 and PS2 polymorphisms; thus, these polymorphisms do not appear to be sufficient risk factors by themselves for sporadic AD. Although the ApoE varepsilon4 genotype is the only definite predictor of risk, homozygosity for either the 1 allele of the PS1 or the C allele of the PS2 genes may increase the risk conferred by the presence of an ApoE epsilon4 allele. Additionally, combination of PS1/11 and PS2/CC genotypes might have a small synergistic effect on the risk for AD.

We compare the results of a matched cohort study with those yielded by analysis of covariance (ANCOVA) in the cohort where the matched study was nested to assess whether the matching design underestimates (as it has been assumed) the extra length of hospitalization due to nosocomial infection. A total of 218 patients developed hospital infection in a cohort of 1483 general surgery patients; 161 were successfully matched 1:1 for surgical procedure, ASA score, age (+/-10 years), emergency-scheduled surgery, preoperative stay, and, whenever possible, number of diagnoses and sex. Unmatched infected patients (57, 23.1%) were different from matched ones. There were no differences for the variables between matched infected patients and their pairs. The matched cohort study overestimates the extra LOH due to hospital infection. The use of ANCOVA in the total cohort obviates the selection bias of the matched cohort design.

The role of report/recall bias in case-control studies of low birth weight (LBW) was investigated in women who gave birth at a tertiary hospital. Prenatal exposure information reported at the postpartum interview was compared with that documented during pregnancy in obstetric records. 169 cases of LBW and 198 controls were selected. The two sets of information on case mothers and control mothers were compared, using the medical record as a reference. Kappa values were estimated. No trend was observed to increase/decrease the sensitivity and specificity of recall. Agreement on alcohol use was very low (kappa = 0.11 for case mothers and 0.03 for control mothers): on obstetrical records, only 12 mothers of cases reported habitual alcohol intake at the first prenatal care visit, whereas in the interview 69 said yes to the same question; in control mothers, the figures were 4 and 89 respectively. Odds ratios (ORs) of exposure estimated from the two sets of data did not differ importantly in 8 variables. Interview data yielded ORs for hypertension (8.39 versus 4.63), anemia (0.44 versus 0.99) that were farther from the null, and ORs in the opposite direction for alcohol (0.83 versus 1.61) and any drug (0.64 versus 1.42). In conclusion, given that OR figures are similar for most variables and no trend is observed in sensitivity/specificity, mothers of normal births can be an adequate reference group, using personal interviews to obtain information on lifestyle, and medical records for conditions.