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Two-Year Changes in Physical Activity and Concurrent Changes in Cognitive Function in a Cohort of Adults with Metabolic Syndrome.
Rognoni, T, Fernández-Matarrubia, M, Martinez-González, MÁ, Salas-Salvadó, J, Corella, D, Castañer, O, Martínez, JA, Alonso-Gómez, ÁM, Gómez-Gracia, E, Vioque, J, et al
Journal of Alzheimer's disease : JAD. 2023;(3):887-899
Abstract
BACKGROUND It has been proposed that physical activity (PA) could prevent cognitive decline. OBJECTIVE To evaluate the association between changes in PA and changes in cognitive function in a cohort of adults with metabolic syndrome. METHODS Longitudinal observational study including 5,500 adults (mean age 65 years, SD = 5; women = 49.3% ) with metabolic syndrome. Participants underwent physical activity measurements and cognitive evaluation at baseline and at two-years of follow-up. PA was quantified using the Minnesota questionnaire-shortened version. Cognitive function was evaluated using a battery of tests: Mini-Mental Test Examination, Clock Drawing Test, Trail Making Test A and B, Verbal Fluency Test, and Digit Span. The primary outcome was two-year change in cognition, measured through the Global Composite Score (GCS) of all neuropsychological tests. Multivariable-adjusted linear regression models were fitted with baseline PA and their changes as the main exposures and changes in cognitive function as the outcome. RESULTS No significant association was found between PA levels (or their changes) in the GCS of cognitive function. A greater increase in PA levels was associated with a more favorable two-year change in the Trail Making Test A (Q4 versus Q1: b = - 2.24s, 95% CI -4.36 to -0.12s; p-trend = 0.020). No significant association was found for other neuropsychological test. CONCLUSION Our results do not support an association between increases in PA and the evolution of the global cognitive function at two-year in an intervention trial which included PA promotion in one of its two randomized arms, but they suggested a possible beneficial effect of PA on attentional function in older adults.
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Nut consumption is associated with a shift of the NMR lipoprotein subfraction profile to a less atherogenic pattern among older individuals at high CVD risk.
García-Gavilán, JF, Connelly, MA, Babio, N, Mantzoros, CS, Ros, E, Salas-Salvadó, J
Cardiovascular diabetology. 2022;(1):189
Abstract
BACKGROUND Scientific evidence has accumulated on the beneficial effects of nut consumption on cardiovascular risk and cholesterol reduction, but few studies have examined the effects of nuts on advanced measures of lipoprotein atherogenicity determined by nuclear magnetic resonance (NMR) spectroscopy. We analyzed associations between the amount and type of of nuts consumed and advanced measures of lipoprotein atherogenity and insulin resistance in older individuals at high cardiovascular risk. METHODS The present observational study was carried out within the framework of the Prevención con Dieta Mediterránea (PREDIMED) trial. Cross-sectional and longitudinal analyses after 1-year of follow-up were conducted in 196 men and women recruited in the PREDIMED-Reus (Spain) center. Dietary intake was assessed using a validated semi-quantitative food questionnaire. Baseline and 1-year fasting plasma lipoprotein and metabolite profiling were performed in plasma using NMR spectra Vantera® Clinical Analyzer. Associations by tertiles of nut consumption between baseline and 1-year changes and advanced measures of lipoprotein atherogenicity, branched chain amminoacids, and measures of insulin resistance were tested by multivariable-adjusted ANCOVA models. RESULTS Compared to paticipants in the bottom tertile, those in the top tertile of total nut consumption showed higher levels of large HDL particles and HDL-cholesterol, lower levels of branched-chain amino acids (BCAA) and GlycA, and reduced lipoprotein insulin resistance and diabetes risk index. Participants in the top tertile of walnut consumption disclosed lower levels of very large VLDL, total LDL particles, LDL-cholesterol, and GlycA. Participants in the top tertile of non-walnut nut consumption displayed higher levels of total HDL particles, HDL-cholesterol and apoliporotein A1, lower BCAA and GlycA, and reduced lipoprotein insulin resistance. Participants in the top tertile of 1-year changes in walnut consumption showed increases in medium-sized HDL particles in comparison to the bottom tertile. CONCLUSIONS In older individuals at high cardiovascular risk, increasing nut consumption was associated with a shift of the NMR lipoprotein subfraction profile to a less atherogenic pattern, as well as lower circulating concentrations of BCAA and decreased insulin resistance. These results provide novel mechanistic insight into the cardiovascular benefit of nut consumption. Trial registration ISRCTN35739639; registration date: 05/10/2005; recruitment start date 01/10/2003.
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Leisure time physical activity is associated with improved HDL functionality in high cardiovascular risk individuals: a cohort study.
Hernáez, Á, Soria-Florido, MT, Castañer, O, Pintó, X, Estruch, R, Salas-Salvadó, J, Corella, D, Alonso-Gómez, Á, Martínez-González, MÁ, Schröder, H, et al
European journal of preventive cardiology. 2021;(12):1392-1401
Abstract
AIMS: Physical activity has consistently been shown to improve cardiovascular health and high-density lipoprotein-cholesterol levels. However, only small and heterogeneous studies have investigated the effect of exercise on high-density lipoprotein functions. Our aim is to evaluate, in the largest observational study to date, the association between leisure time physical activity and a range of high-density lipoprotein functional traits. METHODS The study sample consisted of 296 Spanish adults at high cardiovascular risk. Usual leisure time physical activity and eight measures of high-density lipoprotein functionality were averaged over two measurements, one year apart. Multivariable linear regression models were used to explore the association between leisure time physical activity (exposure) and each high-density lipoprotein functional trait (outcome), adjusted for cardiovascular risk factors. RESULTS Higher levels of leisure time physical activity were positively and linearly associated with average levels over one year of plasma high-density lipoprotein-cholesterol and apolipoprotein A-I, paraoxonase-1 antioxidant activity, high-density lipoprotein capacity to esterify cholesterol and cholesterol efflux capacity in individuals free of type 2 diabetes only. The increased cholesterol esterification index with increasing leisure time physical activity reached a plateau at around 300 metabolic equivalents.min/day. In individuals with diabetes, the relationship with cholesteryl ester transfer protein followed a U-shape, with a decreased cholesteryl ester transfer protein activity from 0 to 300 metabolic equivalents.min/day, but increasing from there onwards. Increasing levels of leisure time physical activity were associated with poorer high-density lipoprotein vasodilatory capacity. CONCLUSIONS In a high cardiovascular risk population, leisure time physical activity was associated not only with greater circulating levels of high-density lipoprotein-cholesterol, but also with better markers of high-density lipoprotein functionality, namely cholesterol efflux capacity, the capacity of high-density lipoprotein to esterify cholesterol and paraoxonase-1 antioxidant activity in individuals free of diabetes and lower cholesteryl ester transfer protein activity in individuals with type 2 diabetes.
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Simple sugar intake and cancer incidence, cancer mortality and all-cause mortality: A cohort study from the PREDIMED trial.
Laguna, JC, Alegret, M, Cofán, M, Sánchez-Tainta, A, Díaz-López, A, Martínez-González, MA, Sorlí, JV, Salas-Salvadó, J, Fitó, M, Alonso-Gómez, ÁM, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(10):5269-5277
Abstract
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 incidence was found per 5 g/day increase in intake of liquid sugars, with multivariable-adjusted HR of 1.08 (95% CI, 1.03-1.13) for total liquid sugar, 1.19 (95% CI, 1.07-1.31) for liquid glucose, 1.14 (95% CI, 1.05-1.23) for liquid fructose, and 1.39 (95% CI, 1.10-1.74) for fructose from fruit juice. Cancer and all-cause mortality increased to a similar extent with intake of all sugars in liquid form. In categorical models, cancer risk was dose-related for all liquid sugars. CONCLUSIONS Simple sugar intake in drinks and fruit juice was associated with an increased risk of overall cancer incidence and mortality and all-cause mortality. This suggests that sugary beverages are a modifiable risk factor for cancer and all-cause mortality.
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Targeting body composition in an older population: do changes in movement behaviours matter? Longitudinal analyses in the PREDIMED-Plus trial.
Galmes-Panades, AM, Konieczna, J, Varela-Mato, V, Abete, I, Babio, N, Fiol, M, Antonio de Paz, J, Casas, R, Olbeyra, R, Ruiz-Canela, M, et al
BMC medicine. 2021;19(1):3
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Expert Review
Conflicts of interest:
None
Take Home Message:
- The importance of including daily physical activity in place of sedentary behaviour.
- The additional benefits of moderate-to vigorous physical activity.
- The importance of seeking medical advice before commencing a physical activity programme
- The importance of working with qualified exercise prescribers when embarking on a new activity programme
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction:
Authors highlight that although the relationship between physical activity (PA), sedentary behaviour (SB) and markers of obesity and body composition (BC) have been studied extensively, the balance between PA at different levels of intensity e.g. light physical activity (LPA) intensity and medium to vigorous activity (MVPA) intensity as well as SB in older, obese/overweight adults remains unclear.
Aim and Objectives:
This longitudinal, observational prospective study aimed to explore the relationships between PA and SB in an older population with Metabolic Syndrome (MetS) over a period of 12 weeks (n=1564).
The objectives were specifically to:
1. Evaluate the relationship of concurrent changes in self=reported PA and SB with body composition changes at 12 months using dual-energy X-ray absorptiometry (DEXA).
2. Evaluate the impact of replacing SB with PA at different intensities (LA and MVPA) on BC changes.
Accelerometer-derived inactive time (IT) data was used as a proxy for SB.
Study Design:
The study was nested in the PREDIMED-Plus trial, registered at ISRCTN (89898870). 1564 participants were recruited for the sub-sample (men aged 55-75 n=813; women aged 60-75 n=751) with a BMI >27 and < 40kg/m2 and 3 components of MetS. Data was collected at baseline, 6 and 12 months.
Intervention:
Multicomponent weight loss based on energy restricted Mediterranean Diet (erMedDiet), increasing 30 mins of total PA with behavioural support.
Control:
MedDiet without energy restriction or additional support.
Results:
- At 12 months, participants (intervention and control groups) reduced their waist circumference, BMI, body fat, visceral adipose tissue (VAT) and total energy intake compared to baseline. They increased percentage of muscle mass and muscle-to-fat mass ratio.
- At 6 and 12 months, participants accrued more total PA, LPA and MVPA and less total SB compared to baseline.
After adjustment for potential confounders:
- Increasing 30 min of PA was significantly associated with a decrease in body fat (β − 0.07%, 95% CIs − 0.10; − 0.04%) and VAT (− 13.9 g; − 21.5; − 6.23) and increased muscle mass (0.07%; 0.04; 0.10) and muscle-to-fat mass ratio (0.41; 0.15; 0.67).
- Increasing 30 min of MVPA was linked to significantly reduced body fat (− 0.08%, − 0.11; − 0.04%) and VAT (− 15.6 g; − 24.1; − 7.25) and with increased muscle mass (0.07%; 0.04; 0.10) and muscle-to-fat mass ratio (0.44; 0.15; 0.72).
- Overall, 30 more minutes of total SB was associated with significantly greater body fat and lower muscle mass.
- No significant associations were observed for LPA.
Conclusions:
Increasing PA and substituting SB with PA, in particular MVPA is correlated with improvements in body composition in overweight or obese older adults with MetS.
Clinical practice applications:
- To inform older clients (>55yrs) on the benefits of PA on a range of health conditions e.g. cardiovascular disease and symptoms e.g. metabolic symptoms
- To provide guidance on the benefits of replacing SB with PA, with examples of optimal amount of time and intensity, obviously working within professional boundaries and referring on to relevant experts when necessary
- To encourage practitioners to include recommendations of physical activity as part of a comprehensive approach to physical well-being
Considerations for future research:
- Analyse how increases in physical activity may benefit other chronic health conditions in older adults
- Evaluate how exchanging sedentary behaviour with physical activity may benefit mental health symptoms such as mood and anxiety in adults.
- Explore different facilitators and barriers to increasing physical activity to reduce sedentary behaviour in adults.
Abstract
BACKGROUND The optimal distribution between physical activity (PA) levels and sedentary behaviour (SB) for the greatest benefits for body composition among older adults with overweight/obesity and chronic health conditions remains unclear. We aimed to determine the prospective association between changes in PA and in SB with concurrent changes in body composition and to examine whether reallocating inactive time into different physical activity levels was associated with 12-month change to body composition in older adults. METHODS Longitudinal assessment nested in the PREDIMED-Plus trial. A subsample (n = 1564) of men and women (age 55-75 years) with overweight/obesity and metabolic syndrome from both arms of the PREDIMED-Plus trial was included in the present analysis. Participants were followed up at 6 and 12 months. Physical activity and SB were assessed using validated questionnaires. Out of 1564 participants, 388 wore an accelerometer to objectively measure inactive time and PA over a 7-day period. At each time point, participants' body composition was measured using dual-energy X-ray absorptiometry (DXA). Standard covariate-adjusted and isotemporal substitution modelling were applied to linear mixed-effects models. RESULTS Increasing 30 min of total PA and moderate-to-vigorous physical activity (MVPA) was associated with significant reductions in body fat (β - 0.07% and - 0.08%) and visceral adipose tissue (VAT) (- 13.9 g, and - 15.6 g) at 12 months (all p values < 0.001). Reallocating 30 min of inactive time to MVPA was associated with reductions in body fat and VAT and with an increase in muscle mass and muscle-to-fat mass ratio (all p values < 0.001). CONCLUSIONS At 12 months, increasing total PA and MVPA and reducing total SB and TV-viewing SB were associated with improved body composition in participants with overweight or obesity, and metabolic syndrome. This was also observed when substituting 30 min of inactive time with total PA, LPA and MVPA, with the greatest benefits observed with MVPA. TRIAL REGISTRATION International Standard Randomized Controlled Trial (ISRCTN), 89898870 . Retrospectively registered on 24 July 2014.
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Glycemic Dysregulations Are Associated With Worsening Cognitive Function in Older Participants at High Risk of Cardiovascular Disease: Two-Year Follow-up in the PREDIMED-Plus Study.
Gómez-Martínez, C, Babio, N, Júlvez, J, Becerra-Tomás, N, Martínez-González, MÁ, Corella, D, Castañer, O, Romaguera, D, Vioque, J, Alonso-Gómez, ÁM, et al
Frontiers in endocrinology. 2021;:754347
Abstract
INTRODUCTION Type 2 diabetes has been linked to greater cognitive decline, but other glycemic parameters such as prediabetes, diabetes control and treatment, and HOMA-IR and HbA1c diabetes-related biomarkers have shown inconsistent results. Furthermore, there is limited research assessing these relationships in short-term studies. Thus, we aimed to examine 2-year associations between baseline diabetes/glycemic status and changes in cognitive function in older participants at high risk of cardiovascular disease. METHODS We conducted a 2-year prospective cohort study (n=6,874) within the framework of the PREDIMED-Plus study. The participants (with overweight/obesity and metabolic syndrome; mean age 64.9 years; 48.5% women) completed a battery of 8 cognitive tests, and a global cognitive function Z-score (GCF) was estimated. At baseline, participants were categorized by diabetes status (no-diabetes, prediabetes, and <5 or ≥5-year diabetes duration), and also by diabetes control. Furthermore, insulin resistance (HOMA-IR) and glycated hemoglobin (HbA1c) levels were measured, and antidiabetic medications were recorded. Linear and logistic regression models, adjusted by potential confounders, were fitted to assess associations between glycemic status and changes in cognitive function. RESULTS Prediabetes status was unrelated to cognitive decline. However, compared to participants without diabetes, those with ≥5-year diabetes duration had greater reductions in GCF (β=-0.11 (95%CI -0.16;-0.06)], as well as in processing speed and executive function measurements. Inverse associations were observed between baseline HOMA-IR and changes in GCF [β=-0.0094 (95%CI -0.0164;-0.0023)], but also between HbA1c levels and changes in GCF [β=-0.0085 (95%CI -0.0115, -0.0055)], the Mini-Mental State Examination, and other executive function tests. Poor diabetes control was inversely associated with phonologic fluency. The use of insulin treatment was inversely related to cognitive function as measured by the GCF [β=-0.31 (95%CI -0.44, -0.18)], and other cognitive tests. CONCLUSIONS Insulin resistance, diabetes status, longer diabetes duration, poor glycemic control, and insulin treatment were associated with worsening cognitive function changes in the short term in a population at high cardiovascular risk. CLINICAL TRIAL REGISTRATION http://www.isrctn.com/ISRCTN89898870, identifier ISRCTN 89898870.
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Adherence to Mediterranean Diet or Physical Activity After Bariatric Surgery and Its Effects on Weight Loss, Quality of Life, and Food Tolerance.
Gils Contreras, A, Bonada Sanjaume, A, Becerra-Tomás, N, Salas-Salvadó, J
Obesity surgery. 2020;(2):687-696
Abstract
OBJECTIVE To assess whether a healthy dietary pattern or physical activity after bariatric surgery mediates the effects of surgery on weight loss, the quality of life, or food tolerance. METHODS A prospective observational study conducted in the context of a randomized controlled trial. We assessed the extent to which increasing or decreasing adherence to the Mediterranean diet (MedDiet)-assessed by MEDAS (Mediterranean Diet Adherence Screener)-and of increasing or decreasing physical activity (PA)-assessed with the Short Questionnaire of International PA (IPAQ-Short Q)-after bariatric surgery affected changes in weight, body mass index (BMI), quality of life (Moorehead-Arlet Questionnaire), and food tolerance (Suter test). Assessments were recorded at baseline and quarterly up to 12 months of surgery. RESULTS Seventy-eight morbidly obese participants undergoing bariatric surgery were assessed up to 1 year after surgery. Those individuals who increased adherence to MedDiet showed a significantly higher mean of total weight loss percentage than those who decreased or maintained their adherence during follow-up: 37.6% (35.5-39.8) versus 34.1% (31.8-36.5) (p = 0.036). No significant differences were observed in changes in weight or BMI comparing individuals who increased their PA versus those who maintained or decreased PA, nor in quality of life or food tolerance between those individuals who increased versus those who decreased adherence to MedDiet or PA during the follow-up. CONCLUSIONS After bariatric surgery, morbidly obese subjects present greater weight loss if they adhere to the MedDiet. PA after surgery is not associated with the magnitude of weight loss nor the quality of life and tolerance to diet.
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Changes in arginine are inversely associated with type 2 diabetes: A case-cohort study in the PREDIMED trial.
Yu, E, Ruiz-Canela, M, Razquin, C, Guasch-Ferré, M, Toledo, E, Wang, DD, Papandreou, C, Dennis, C, Clish, C, Liang, L, et al
Diabetes, obesity & metabolism. 2019;(2):397-401
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Abstract
The associations between arginine-based metabolites and incident type 2 diabetes (T2D) are unknown. We employed a case-cohort design, nested within the PREDIMED trial, to examine six plasma metabolites (arginine, citrulline, ornithine, asymmetric dimethylarginine [ADMA], symmetric dimethylarginine [SDMA] and N-monomethyl-l-arginine [NMMA]) among 892 individuals (251 cases) for associations with incident T2D and insulin resistance. Weighted Cox models with robust variance were used. The 1-year changes in arginine (adjusted hazard ratio [HR] per SD 0.68, 95% confidence interval [CI] 0.49, 0.95; Q4 vs. Q1 0.46, 95% CI 0.21, 1.04; P trend = 0.02) and arginine/ADMA ratio (adjusted HR per SD 0.73, 95% CI 0.51, 1.04; Q4 vs. Q1 0.52, 95% CI 0.22, 1.25; P trend = 0.04) were associated with a lower risk of T2D. Positive changes of citrulline and ornithine, and negative changes in SDMA and arginine/(ornithine + citrulline) were associated with concurrent 1-year changes in homeostatic model assessment of insulin resistance. Individuals in the low-fat-diet group had a higher risk of T2D for 1-year changes in NMMA than individuals in Mediterranean-diet groups (P interaction = 0.02). We conclude that arginine bioavailability is important in T2D pathophysiology.
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Mediterranean alcohol-drinking pattern, low to moderate alcohol intake and risk of atrial fibrillation in the PREDIMED study.
Bazal, P, Gea, A, Martínez-González, MA, Salas-Salvadó, J, Asensio, EM, Muñoz-Bravo, C, Fiol, M, Muñoz, MA, Lapetra, J, Serra-Majem, LL, et al
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2019;(7):676-683
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Abstract
BACKGROUND AND AIMS There is ongoing controversy about the effect of a low to moderate alcohol consumption on atrial fibrillation (AF). Our aim is to assess the association between adherence to a Mediterranean alcohol drinking pattern and AF incidence. METHODS AND RESULTS A total 6527 out of the 7447 participants in the PREDIMED trial met our inclusion criteria. A validated frequency food questionnaire was used to measure alcohol consumption. Participants were classified as non-drinkers, Mediterranean alcohol drinking pattern (MADP) (10-30 g/d in men and 5-15 g/day in women, preferably red wine consumption with low spirits consumption), low-moderate drinking (<30 g/day men y and < 15 g/day women), and heavy drinking. We performed multivariable Cox regression models to estimate hazard ratios (HR) with 95% confidence intervals (95% CI) of incident AF according to alcohol drinking patterns. After a mean follow up of 4.4 years, 241 new incident AF cases were confirmed. Alcohol consumption was not associated to AF incidence among low-moderate drinkers (HR: 0.96; 95%CI: 0.67-1.37), adherents to MADP (HR: 1.15 95%CI: 0.75-1.75), or heavy drinkers (HR: 0.92; 95%CI: 0.53-1.58), compared with non-drinkers. CONCLUSIONS In a high cardiovascular risk adult population, a Mediterranean alcohol consumption pattern (low to moderate red wine consumption) was not associated with an increased incidence of AF. CLINICAL TRIALS URL: http://www.controlled-trials.com. Unique identifier: ISRCTN35739639.
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Legume consumption and risk of all-cause, cardiovascular, and cancer mortality in the PREDIMED study.
Papandreou, C, Becerra-Tomás, N, Bulló, M, Martínez-González, MÁ, Corella, D, Estruch, R, Ros, E, Arós, F, Schroder, H, Fitó, M, et al
Clinical nutrition (Edinburgh, Scotland). 2019;(1):348-356
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BACKGROUND & AIMS Limited prospective studies have examined the association between legumes consumption and mortality, whereas scarce, if at all, previous studies have evaluated such associations taking into consideration specific grain legumes. We aimed to investigate the association between total legumes consumption and grain legumes species (dry beans, chickpeas, lentils, and fresh peas) with all-cause, cardiovascular disease (CVD), cancer and other-cause mortality among elderly Mediterranean individuals at high CVD risk. METHODS We prospectively assessed 7216 participants from the PREvención con DIeta MEDiterránea study. Dietary intake was assessed at baseline and yearly during follow-up by using a validated food frequency questionnaire. RESULTS During a median follow-up of 6.0 years, 425 total deaths, 103 CVD deaths, 169 cancer deaths and 153 due to other-causes deaths occurred. Hazard ratios (HRs) [95% confidence interval (CI)] of CVD mortality were 1.52 (1.02-2.89) (P-trend = 0.034) and 2.23 (1.32-3.78) (P-trend = 0.002) for the 3rd tertile of total legumes and dry beans consumption, respectively, compared with the 1st tertile. When comparing extreme tertiles, higher total legumes and lentils consumption was associated with 49% (HR: 0.51; 95% CI: 0.31-0.84; P-trend = 0.009) and 37% (HR: 0.63; 95% CI: 0.40-0.98; P-trend = 0.049) lower risk of cancer mortality. Similar associations were observed for CVD death in males and for cancer death in males, obese and diabetic participants. CONCLUSIONS These findings support the benefits of legumes consumption for cancer mortality prevention which may be counterbalanced by their higher risk for CVD mortality. TRIAL REGISTRATION The trial is registered at http://www.controlled-trials.com (ISRCTN35739639). Registration date: 5th October 2005.