Maternal factors associated with iron deficiency without anaemia in early pregnancy: ECLIPSES study.

Several population-specific genetic, sociodemographic, and maternal lifestyle factors are related to iron status in early pregnancy, and their identification would allow preventive actions to be taken. The study aimed to identify maternal factors associated with iron deficiency (ID) in early pregnancy in non-anaemic pregnant women from a European Mediterranean country. Cross-sectional study using the initial population of the ECLIPSES study performed in non-anaemic pregnant women before gestational week 12. Serum ferritin (SF) and haemoglobin concentrations were measured to evaluate iron status, and ID was defined as SF < 15 µg/L. Several sociodemographic and lifestyle data were recorded and used as covariates in the multivariate-adjusted regression models. Out of the 791 participants, 13.9% had ID in early pregnancy. Underweight (OR 3.70, 95%CI 1.22, 15.53) and parity (1 child: OR 2.03, 95%CI 1.06, 3.88; ≥ 2 children: OR 6.96, 95%CI 3.09, 15.69) increased the odds of ID, while a high intake of total meat (≥ 108.57 g/day: OR 0.37, 95%CI 0.15, 0.87), red/processed meat (≥ 74.29 g/day: OR 0.70, 95%CI 0.35, 0.98), protein (≥ 65.05 g/day: OR 0.85, 95%CI 0.30, 0.99), and dietary iron (≥ 8.58 mg/day: OR 0.58, 95%CI 0.35, 0.94) protected against it. Smoking was also associated with a reduction in ID odds (OR 0.34, 95%CI 0.12, 0.99). Baseline BMI, parity, smoking, and diet are associated with ID in early pregnancy in non-anaemic women. Pregnancy planning policies should focus on women at higher risk of ID, such as those who are underweight, multiparous, or following vegetarian diets. This clinical trial was registered at www.clinicaltrialsregister.eu as EudraCT number 2012-005,480-28 and at www.clinicaltrials.gov with identification number NCT03196882.

Diagnosis accuracy of waist-to-height ratio to predict cardiometabolic risk in children with obesity.

BACKGROUND: Waist-to-height ratio (WHtR) predicts abdominal fat and cardiometabolic risk. In children with obesity, the most adequate cut-off to predict cardiometabolic risk as well as its ability to predict risk changes over time has not been tested. Our aim was to define an appropriate WHtR cut-off to predict cardiometabolic risk in children with obesity, and to analyze its ability to predict changes in cardiometabolic risk over time. METHODS: This is an observational prospective study secondary to the OBEMAT2.0 trial. We included data from 218 participants (8-15 years) who attended baseline and final visits (12 months later). The main outcome measure was a cardiometabolic risk score derived from blood pressure, lipoproteins, and HOMA index of insulin resistance. RESULTS: The optimal cut-off to predict the cardiometabolic risk score was WHtR ≥0.55 with an area under the curve of 0.675 (95% CI: 0.589-0.760) at baseline and 0.682 (95% CI: 0.585-0.779) at the final visit. Multivariate models for repeated measures showed that changes in cardiometabolic risk were significantly associated with changes in WHtR. CONCLUSION: This study confirms the clinical utility of WHtR to predict changes in cardiometabolic risk over time in children with obesity. The most accurate cut-off to predict cardiometabolic risk in children with obesity was WHtR ≥0.55. IMPACT: In children, there is no consensus on a unique WHtR cut-off to predict cardiometabolic risk. The present work provides sufficient evidence to support the use of the 0.55 boundary. We have a large sample of children with obesity, with whom we compared the previously proposed boundaries according to cardiometabolic risk, and we found the optimal WHtR cut-off to predict it. We also analyzed if a reduction in the WHtR was associated with an improvement in their cardiometabolic profile.

Urinary concentrations of heavy metals in pregnant women living near a petrochemical area according to the industrial activity.

BACKGROUND: The progressive industrialization has resulted in an increase in heavy metal pollution in the environment, which has a dangerous impact on human health. Prenatal exposure to heavy metals, even at very low concentrations, may be especially harmful to pregnant women and their children. Different industrial activities can contribute to heavy metal pollution in a specific area. OBJECTIVE: 1) To explore the concentrations of heavy metals in urine samples of pregnant women, and 2) to evaluate the potential effect of different industrial activities in Tarragona (Spain). METHODS: Urinary levels of four heavy metals (nickel (Ni), cadmium (Cd), mercury (Hg), and lead (Pb)) from 368 pregnant women recruited in the ECLIPSES study were analyzed. Home addresses and all the industries potentially releasing heavy metals were geo-referenced. Buffer zones were established within a 1.5, 3, and 5 km radius at the center of each industry. Subsequently, the number of participants living in and out of each buffer zone was recorded. RESULTS: Urinary levels of Ni and Cd, but not those of Hg and Pb, were obviously increased in pregnant women living near most of the industrial sites. After adjustment for potential co-variates, only Cd showed notable differences according to the industrial activity. Compared to women living outside the buffer, Cd levels were increased in those living within 1.5 and 3 km of chemical industries, within 5 km of energy industries, within 1.5, 3, and 5 km of mineral industries, and within 3 and 5 km of metal processing industries. CONCLUSION: Among the analyzed heavy metals, Cd showed an increasing trend in urinary concentrations in women living near chemical, energy, mineral, and metal processing industries. This study highlights the need to develop legislative measures to minimize Cd exposure, especially by sensitive populations. Moreover, additive or synergistic effects of co-exposure to other air pollutants should not be disregarded.

Vitamin K dietary intake is associated with cognitive function in an older adult Mediterranean population.

BACKGROUND: In the last years, evidence that dietary vitamin K could have a role in the cognitive domain has increased. However, data from large trials are limited. The objective of this study was to assess the association of 2 year changes in the dietary intake of vitamin K with cognitive function measured through neuropsychological performance tests. METHODS: In 5,533 participants of the multicentre PREDIMED-Plus study (48.1% women, age 65.1 ± 4.9 years with overweight/obesity and metabolic syndrome), we assessed the adjusted odds ratios of cognitive function decline according to 2 year changes in vitamin K intake. Participants answered a battery of cognitive function tests and Food Frequency Questionnaires (FFQs) in order to estimate the vitamin K dietary intake. RESULTS: After adjusting for potential cofounders, the highest tertile of change of dietary vitamin K intake (median [IQR]; 194.4 µg/d [120.9, 373.1]) was inversely associated with a Mini-Mental State Examination (MMSE) score ≤24 (OR [95% CI]; 0.53 [0.35, 0.79] P for trend = 0.002) compared with a decrease in the intake of vitamin K (median [IQR]; -97.8 µg/d [-292.8, -51.5]). A significant positive association between changes in dietary vitamin K intake and the semantic verbal fluency test scores (OR [95% CI]; 0.69 [0.51, 0.94] P for trend = 0.019) was found. CONCLUSIONS: An increase of the intake of dietary vitamin K was associated with better cognitive function scores, independently of recognised risk factors for cognitive decline, in an older adult Mediterranean population with high cardiovascular risk.

Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts.

BACKGROUND: Observational cohort studies and a secondary prevention trial have shown inverse associations between adherence to the Mediterranean diet and cardiovascular risk. METHODS: In a multicenter trial in Spain, we assigned 7447 participants (55 to 80 years of age, 57% women) who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was a major cardiovascular event (myocardial infarction, stroke, or death from cardiovascular causes). After a median follow-up of 4.8 years, the trial was stopped on the basis of a prespecified interim analysis. In 2013, we reported the results for the primary end point in the Journal. We subsequently identified protocol deviations, including enrollment of household members without randomization, assignment to a study group without randomization of some participants at 1 of 11 study sites, and apparent inconsistent use of randomization tables at another site. We have withdrawn our previously published report and now report revised effect estimates based on analyses that do not rely exclusively on the assumption that all the participants were randomly assigned. RESULTS: A primary end-point event occurred in 288 participants; there were 96 events in the group assigned to a Mediterranean diet with extra-virgin olive oil (3.8%), 83 in the group assigned to a Mediterranean diet with nuts (3.4%), and 109 in the control group (4.4%). In the intention-to-treat analysis including all the participants and adjusting for baseline characteristics and propensity scores, the hazard ratio was 0.69 (95% confidence interval [CI], 0.53 to 0.91) for a Mediterranean diet with extra-virgin olive oil and 0.72 (95% CI, 0.54 to 0.95) for a Mediterranean diet with nuts, as compared with the control diet. Results were similar after the omission of 1588 participants whose study-group assignments were known or suspected to have departed from the protocol. CONCLUSIONS: In this study involving persons at high cardiovascular risk, the incidence of major cardiovascular events was lower among those assigned to a Mediterranean diet supplemented with extra-virgin olive oil or nuts than among those assigned to a reduced-fat diet. (Funded by Instituto de Salud Carlos III, Spanish Ministry of Health, and others; Current Controlled Trials number, ISRCTN35739639 .).

U-Shaped Association between Dietary Acid Load and Risk of Osteoporotic Fractures in 2 Populations at High Cardiovascular Risk.

BACKGROUND: Bone contributes to maintaining the acid-base balance as a buffering system for blood pH. Diet composition also affects acid-base balance. Several studies have linked an imbalance in the acid-base system to changes in the density and structure of bone mass, although some prospective studies and meta-analyses suggest that acid load has no deleterious effect on bone. OBJECTIVE: The aim of this study was to examine the associations between potential renal acid load (PRAL) and net endogenous acid production (NEAP) and the risk of osteoporotic fractures and bone mineral density (BMD) in 2 middle-aged and elderly Mediterranean populations. METHODS: We conducted a longitudinal analysis including 870 participants from the PREvención con DIeta MEDiterranea (PREDIMED) Study and a cross-sectional analysis including 1134 participants from the PREDIMED-Plus study. Participants were adults, aged 55-80 y, either at high cardiovascular risk (PREDIMED) or overweight/obese with metabolic syndrome (PREDIMED-Plus), as defined by the International Diabetes Federation, the American Heart Association, and the National Heart Association. PRAL and NEAP were calculated from validated food-frequency questionnaires. BMD was measured using DXA scans. Fracture information was obtained from medical records. The association between mean PRAL and NEAP and fracture risk was assessed using multivariable-adjusted Cox models. BMD differences between tertiles of baseline PRAL and NEAP were evaluated by means of ANCOVA. RESULTS: A total 114 new fracture events were documented in the PREDIMED study after a mean of 5.2 y of intervention and 8.9 y of total follow-up. Participants in the first and third PRAL and NEAP tertiles had a higher risk of osteoporotic fracture compared with the second tertile, showing a characteristically U-shaped association [HR (95% CI): 1.73 (1.03, 2.91) in tertile 1 and 1.91 (1.14, 3.19) in tertile 3 for PRAL, and 1.83 (1.08, 3.09) in tertile 1 and 1.87 (1.10, 3.17) in tertile 3 for NEAP]. Compared with the participants in tertile 1, the participants in the top PRAL and NEAP tertiles had lower BMD [PRAL: mean total femur BMD: 1.029 ± 0.007 and 1.007 ± 0.007 g/cm2; P = 0.006 (tertiles 1 and 3); NEAP: mean total femur BMD: 1.032 ± 0.007 and 1.009 ± 0.007 g/cm2; P = 0.017 (tertiles 1 and 3)]. CONCLUSIONS: The results of our study suggest that both high and low dietary acid are associated with a higher risk of osteoporotic fractures, although only high dietary acid was found to have a negative relation to BMD in senior adults with existing chronic health conditions. This trial was registered at http://www.isrctn.com/ as ISRCTN3573963 (PREDIMED) and ISRCTN89898870 (PREDIMED-Plus).

Perinatal emotional states: a comparative study between two cohorts recruited in a Mediterranean environment.

Experiencing negative emotional states during pregnancy has been linked to adverse outcomes for mother and offspring. Our study aims were to compare the perinatal emotional states and obstetrical variables between pregnant women recruited in Spain (n = 202) and Italy (n = 103), and to investigate prenatal anxiety related factors. The study had two phases. In the 1st phase (3rd trimester of pregnancy), prenatal anxiety was assessed using the State-Trait Anxiety Inventory (STAI); other prenatal and sociodemographic variables were also collected. In the 2nd phase (40 days postpartum), the STAI and the Edinburgh Postnatal Depression Scale were administered. Compared to the Spanish sample, the Italian sample presented higher STAI state and STAI factor 1 mean scores (22.5 vs. 18.6 and 10.0 vs. 7.2), shorter gestations (mean gestation weeks: 39.1 vs. 39.8), more unplanned pregnancies (31.1% vs. 16.4%), and more cesareans deliveries (42.5% vs. 16.0%). Low socioeconomic levels, younger ages, previous miscarriages and unplanned pregnancies were related to prenatal anxiety. Postpartum depression rates was 31.3% and there were no differences between countries. Our results suggested that it may be interesting in both countries to create a prenatal monitoring protocol that attaches more importance to emotional wellbeing both during pregnancy and in the long term.

Dairy products intake and the risk of incident cataracts surgery in an elderly Mediterranean population: results from the PREDIMED study.

PROPOSAL: The aim of this study was to examine the association between the consumption of total and specific types of dairy products and the risk of incident cataracts in an elderly Mediterranean population at high cardiovascular risk. METHODS: We prospectively analyzed 5860 subjects from the PREvención con DIeta MEDiterránea (PREDIMED) Study. The time to cataract surgery was calculated as the time between recruitment and the date of the surgery, last visit of the follow-up, date of death, or until the end of the study. Dairy products intake was assessed using validated food frequency questionnaires. We used Cox proportional hazard regression to assess the risk of cataract surgery according to average dietary energy-adjusted total dairy products, milk, yogurt and cheese consumption. RESULTS: We documented a total of 768 new cataract events after a median of 5.6 years of follow-up. Subjects in the second [hazard ratio (HR) 0.62; 95% CI 0.52, 0.74] and third tertile (HR: 0.71; 95% CI 0.60, 0.85) of skimmed yogurt intake had a significantly lower risk of cataracts after adjusting for potential confounders. No significant associations were observed for total dairy products, whole and skimmed milk, whole yogurt and cheese consumption. CONCLUSION: The intake of skimmed yogurt was associated with a reduced risk of cataracts in an elderly Mediterranean population with high cardiovascular risk. No significant associations were observed for other type of dairy product. CLINICAL TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 35739639. Registration date: 5 October 2005.

Effectiveness of a network of automatically activated trained volunteers on the reduction of cardiopulmonary resuscitation manoueuvers initiation time: study protocol.

BACKGROUND: Cardiorespiratory arrest (CRA) is a health emergency with high mortality. Mortality depends on time of initiation and quality of cardiopulmonary resuscitation (CPR) manoeuvres and the use of the automated external defibrillator (AED). METHODS: The aim of the study is to determine the effectiveness of an automatically activated network of volunteers using smartwatch and smartphone applications on the reduction of time of initiation of cardiopulmonary resuscitation manoeuvres. The protocol will be developed in four phases: 1) validation of an application (App) for smartwatch that automatically generates a health alert in case of out-of-hospital cardiorespiratory arrest (OHCA); 2) training course for laypersons on CPR manoeuvres and AED use; 3) creation of a network of volunteers trained in CPR and AED use that covers our city; and 4) simulation in which the network of volunteers is automatically activated via smartphone to attend simulated OHCAs. A total of 134 health alerts will be generated; on 67 occasions the alert will be directed to the emergency health services and to the network of trained volunteers (Intervention Group) and on 67 occasions the alert will be solely directed to the emergency health services (Control Group). The arrival time of the first rescuer, category of first rescuer (emergency services versus network of volunteers), initiation time of manoeuvres and competence will be recorded. DISCUSSION: CPR training for laypersons is advised, especially for relatives and people close to patients with heart disease, to reduce time of initiation of CPR and to improve OHCA survival rates. This study aims to verify that the initiation time of CPR manoeuvres and AED use is shorter in the intervention than in the control group. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT03828305 . Trial registered on February 1, 2019 (retrospective register).

Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic Syndrome: Interim Analysis of the PREDIMED-Plus Randomized Clinical Trial.

Importance: High-quality dietary patterns may help prevent chronic disease, but limited data exist from randomized trials about the effects of nutritional and behavioral interventions on dietary changes. Objective: To assess the effect of a nutritional and physical activity education program on dietary quality. Design, Setting, and Participants: Preliminary exploratory interim analysis of an ongoing randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years with metabolic syndrome and no cardiovascular disease were enrolled in the trial between September 2013 and December 2016, with final data collection in March 2019. Interventions: Participants were randomized to an intervention group that encouraged an energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral support (n = 3406) or to a control group that encouraged an energy-unrestricted Mediterranean diet (n = 3468). All participants received allotments of extra-virgin olive oil (1 L/mo) and nuts (125 g/mo) for free. Main Outcomes and Measures: The primary outcome was 12-month change in adherence based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher scores indicate greater adherence; minimal clinically important difference, 1 point). Results: Among 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406 [52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months in the intervention group (increase, 4.7 [95% CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months in the control group (increase, 2.5 [95% CI, 2.3-2.6]) (between-group difference, 2.2 [95% CI, 2.1-2.4]; P < .001). Conclusions and Relevance: In this preliminary analysis of an ongoing trial, an intervention that encouraged an energy-reduced Mediterranean diet and physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular effects is needed. Trial Registration: isrctn.com Identifier: ISRCTN89898870.

Dairy product consumption and risk of colorectal cancer in an older mediterranean population at high cardiovascular risk.

Prospective studies have reported an inverse association between the consumption of total dairy products and milk and the risk of colorectal cancer (CRC). Nonetheless, there is little and inconsistent evidence regarding subtypes of dairy product and CRC risk. We assessed the associations between the consumption of total dairy products, their different subtypes and CRC risk in older Mediterranean individuals at high cardiovascular risk. We analyzed data from 7,216 men and women (55-80 years) without CRC at baseline from the PREvención con DIeta MEDiterránea study. Individuals were recruited between 2003 and 2009 and followed up until December 2012. At baseline and yearly thereafter, consumption of total and specific dairy products was assessed using a validated 137-item food-frequency questionnaire. Cox proportional hazards ratios (HRs) of CRC incidence were estimated for tertiles of mean consumption of dairy products during the follow-up. During a median [interquartile range] follow-up of 6.0 [4.4-7.3] years, we documented 101 incident CRC cases. In the multivariable-adjusted models, HRs and 95% confidence intervals (CIs) of CRC for the comparison of extreme tertiles of total dairy product and low-fat milk consumption were 0.55 (95% CI: 0.31-0.99; p-trend = 0.037) and 0.54 (95% CI: 0.32-0.92; p-trend = 0.022), respectively. No significant associations with other dairy products (whole-fat and low-fat dairy products; total, low-fat and whole-fat yogurt; cheese; total, low-fat and whole-fat milk; concentrated full-fat dairy products, sugar-enriched dairy products and fermented dairy products) were found. A high consumption of total dairy products and low-fat milk was significantly associated with a reduced CRC risk.

Effectiveness of the physical activity intervention program in the PREDIMED-Plus study: a randomized controlled trial.

BACKGROUND: The development and implementation of effective physical activity (PA) intervention programs is challenging, particularly in older adults. After the first year of the intervention program used in the ongoing PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial, we assessed the initial effectiveness of the PA component. METHODS: PREDIMED-Plus is an ongoing randomized clinical trial including 6874 participants randomized to an intensive weight-loss lifestyle intervention based on an energy-restricted Mediterranean diet (MedDiet), physical activity promotion and behavioral support and to a control group using MedDiet recommendations but without calorie restriction or PA advice. Body mass index (BMI) and waist circumference (WC) are measured by standard clinical protocols. Duration and intensity of PA is self-reported using the validated REGICOR Short Physical Activity Questionnaire. The primary endpoint of the PREDIMED-Plus trial is a combined cardiovascular outcome: myocardial infarction (acute coronary syndromes with positive troponin test), stroke, or cardiovascular mortality. The present study involved secondary analysis of PA data (n = 6059; mean age 65 ± 4.9 years) with one-year changes in total, light, and moderate-to-vigorous PA within and between intervention groups as the outcome. Generalized estimating equation models were fitted to evaluate time trends of PA, BMI, and WC within groups and differences between intervention and control groups. RESULTS: After 12 months, average daily MVPA increased by 27.2 (95%CI 5.7;48.7) METs-min/day and 123.1 (95%CI 109.7-136.6) METs-min/day in the control and intervention groups, respectively. Total-PA, light-PA, and MVPA increased significantly (p < 0.01) in both groups. A significant (p < 0.001) time*intervention group interaction was found for Total-PA and MVPA, meaning the PA trajectory over time differed between the intervention and control groups. Age, sex, education level, and BMI did not moderate the effectiveness of the PA intervention. BMI and WC decreased significantly with increasing MVPA, compared with participants who reported no changes in MVPA. CONCLUSION: After one year of follow-up, the PREDIMED-Plus PA intervention has been effective in increasing daily PA in older adults. TRIAL REGISTRATION: Retrospectively registered at the International Standard Randomized Controlled Trial ( http://www.isrctn.com/ISRCTN89898870 ), registration date: 24 July 2014.

Interaction between cardiovascular risk factors and body mass index and 10-year incidence of cardiovascular disease, cancer death, and overall mortality.

The effect of above-normal body mass index (BMI) on health outcomes is controversial because it is difficult to distinguish from the effect due to BMI-associated cardiovascular risk factors. The objective was to analyze the impact on 10-year incidence of cardiovascular disease, cancer deaths and overall mortality of the interaction between cardiovascular risk factors and BMI. We conducted a pooled analysis of individual data from 12 Spanish population cohorts with 10-year follow-up. Participants had no previous history of cardiovascular diseases and were 35-79years old at basal examination. Body mass index was measured at baseline being the outcome measures ten-year cardiovascular disease, cancer and overall mortality. Multivariable analyses were adjusted for potential confounders, considering the significant interactions with cardiovascular risk factors. We included 54,446 individuals (46.5% with overweight and 27.8% with obesity). After considering the significant interactions, the 10-year risk of cardiovascular disease was significantly increased in women with overweight and obesity [Hazard Ratio=2.34 (95% confidence interval: 1.19-4.61) and 5.65 (1.54-20.73), respectively]. Overweight and obesity significantly increased the risk of cancer death in women [3.98 (1.53-10.37) and 11.61 (1.93-69.72)]. Finally, obese men had an increased risk of cancer death and overall mortality [1.62 (1.03-2.54) and 1.34 (1.01-1.76), respectively]. In conclusion, overweight and obesity significantly increased the risk of cancer death and of fatal and non-fatal cardiovascular disease in women; whereas obese men had a significantly higher risk of death for all causes and for cancer. Cardiovascular risk factors may act as effect modifiers in these associations.

Physical activity, cardiovascular health, quality of life and blood pressure control in hypertensive subjects: randomized clinical trial.

BACKGROUND: Physical activity (PA) promotes cardiovascular health and health related quality of life (HRQoL), although the effect of that on blood pressure (BP) control has rarely been studied in hypertensive subjects. Our aim was to evaluate the effectiveness of a PA intervention programme on cardiovascular disease (CVD) risk, HRQoL and BP control in hypertensive subjects. METHODS: A randomized clinical trial, with a PA intervention programme of 9 months duration, comprising a walking group of 120 min/week, supervised, and with socio-cultural activities. Participants were 207 hypertensive subjects (68.2 years, 76.8% women). PA (IPAQ-s), diet, CVD risk, BP, BMI, smoking, and HRQoL (SF-36) were assessed at baseline and at the end of the intervention. Changes in CVD risk and in HRQoL during the intervention was calculated (end-baseline score). Multivariate models were applied. RESULTS: In multivariate models, the PA intervention programme, with no modification of the diet, decreased CVD risk (- 1.19 points) and the systolic BP (- 8.68 mmHg), and increased some areas of HRQoL (4.45 to 14.62 points). An increase in the percentage of subjects with controlled BP was observed by the PA programme itself (OR 5.395 to 5.785 according to multivariate models), and by the changes during the intervention in the decrease in CVD risk (OR 0.609) and in the increase in the HRQoL in physical component summary (OR 1.041), role physical (OR 1.010), and bodily pain (OR 1.014), independently of controlled BP at baseline. CONCLUSIONS: This PA intervention programme improved cardiovascular health and HRQoL, and favoured BP control in primary care users with hypertension. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT02767739 ; Trial registered on May 5th, 2016. Retrospectively registered.

Soluble transferrin receptor and risk of type 2 diabetes in the obese and nonobese.

BACKGROUND: Studies evaluating the relationship between soluble transferrin receptor (sTfR), a biomarker inversely related to body iron stores, and risk of type 2 diabetes mellitus (T2DM) are scarce and inconclusive. Furthermore, sTfR concentrations have been observed to be significantly higher in obese than in nonobese individuals. Therefore, the aim of this study was to assess the relationship between sTfR and the risk of T2DM in obese and nonobese subjects. DESIGN: A nested case-control study of 153 cases of newly diagnosed diabetic subjects, 73 obese and 80 nonobese, and 306 individually matched controls, 138 obese and 166 nonobese, who did not develop T2DM for a median 6-year follow-up (interquartile range: 3·9-6·5) was conducted using data from the PREvention with MEDiterranean Diet (PREDIMED) cohort (http://www.controlled-trials.com/ISRCTN35739639). Cases and controls were matched for age (≤ 67 vs. > 67 years), gender, dietary intervention group and BMI (≤ 27 vs. > 27 kg/m2 ). RESULTS: Waist circumference is the main determinant of sTfR concentrations in the whole sample (ß = 0·476, P < 0·001), in the obese (ß = 0·802, P < 0·001) and the nonobese (ß = 0·455, P = 0·003). Furthermore, sTfR is directly associated with the risk of T2DM in obese individuals (OR = 2·79; 95% CI: 1·35-5·77, P = 0·005) and inversely associated in nonobese individuals (OR = 0·40; 95% CI: 0·20-0·79, P = 0·015). CONCLUSIONS: The association between sTfR levels and risk of T2DM in a population at high cardiovascular risk depend on the presence or absence of obesity. While in nonobese subjects elevated sTfR levels are associated with a decreased risk of developing T2DM, in obese subjects the risk increases. This suggests that obesity alters the relationship between sTfR and T2DM incidence.

Effectiveness of a physical activity program on cardiovascular disease risk in adult primary health-care users: the "Pas-a-Pas" community intervention trial.

BACKGROUND: Physical activity is a major, modifiable, risk factor for cardiovascular disease (CVD) that contributes to the prevention and management of CVD. The aim of this study was to assess the short- and medium-term effectiveness of 9 months of a supervised physical activity program, including sociocultural activities, on CVD risk in adults. METHODS: Multicentered, randomized, controlled community intervention involving 364 patients in four primary care centers. The participants were randomly assigned to a Control Group (CG = 104) or Intervention Group (IG = 260); mean age 65.19 years; 76.8% women. The intervention consisted of 120 min/week walking (396 METs/min/week) and sociocultural gathering once a month. Clinical history, physical activity, dietary intake, CVD risk factors (smoking, systolic and diastolic blood pressure, weight, waist circumference, BMI, total cholesterol, LDL- and HDL-cholesterol, triglycerides, glycosylated hemoglobin and glucose) and global CVD risk were assessed at baseline and at the end of the intervention and multivariate models were applied to the data. Incidence of adverse cardiovascular events and continued adherence to the physical activity were assessed 2 years after intervention. RESULTS: At the end of the intervention period, in the IG relative to the CG group, there was a significant increase in physical activity (774.81 METs/min/week), a significant change during the intervention period in systolic blood pressure (-6.63 mmHg), total cholesterol (-10.12 mg/dL) and LDL-cholesterol (-9.05 mg/dL) even after adjustment for potential confounders. At 2 years after the intervention, in the IG, compared with the CG, tthe incidence of adverse cardiovascular events was significantly lower (2.5% vs. 10.5%) and the adherence to regular physical activity was higher (72.8% vs 27.2%) in IG compared to CG. CONCLUSIONS: This community-based physical activity program improved cardiovascular health in the short- as well as medium-term, and promoted regular physical activity in the medium-term in older Spanish adults. TRIALS REGISTRATION: Clinicaltrials.gov ID NCT02767739 . Trial registered on May 5th, 2016. Retrospectively registered.

Primary prevention of cardiovascular disease with a Mediterranean diet.

BACKGROUND: Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events. METHODS: In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years. RESULTS: A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported. CONCLUSIONS: Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. (Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com number, ISRCTN35739639.).

Predictors of short- and long-term adherence with a Mediterranean-type diet intervention: the PREDIMED randomized trial.

BACKGROUND: Dietary intervention success requires strong participant adherence, but very few studies have examined factors related to both short-term and long-term adherence. A better understanding of predictors of adherence is necessary to improve the design and execution of dietary intervention trials. This study was designed to identify participant characteristics at baseline and study features that predict short-term and long-term adherence with interventions promoting the Mediterranean-type diet (MedDiet) in the PREvención con DIeta MEDiterránea (PREDIMED) randomized trial. METHODS: Analyses included men and women living in Spain aged 55-80 at high risk for cardiovascular disease. Participants were randomized to the MedDiet supplemented with either complementary extra-virgin olive oil (EVOO) or tree nuts. The control group and participants with insufficient information on adherence were excluded. PREDIMED began in 2003 and ended in 2010. Investigators assessed covariates at baseline and dietary information was updated yearly throughout follow-up. Adherence was measured with a validated 14-point Mediterranean-type diet adherence score. Logistic regression was used to examine associations between baseline characteristics and adherence at one and four years of follow-up. RESULTS: Participants were randomized to the MedDiet supplemented with EVOO (n = 2,543; 1,962 after exclusions) or tree nuts (n = 2,454; 2,236 after exclusions). A higher number of cardiovascular risk factors, larger waist circumference, lower physical activity levels, lower total energy intake, poorer baseline adherence to the 14-point adherence score, and allocation to MedDiet + EVOO each independently predicted poorer adherence. Participants from PREDIMED recruiting centers with a higher total workload (measured as total number of persons-years of follow-up) achieved better adherence. No adverse events or side effects were reported. CONCLUSIONS: To maximize dietary adherence in dietary interventions, additional efforts to promote adherence should be used for participants with lower baseline adherence to the intended diet and poorer health status. The design of multicenter nutrition trials should prioritize few large centers with more participants in each, rather than many small centers. TRIAL REGISTRATION: This study was registered at controlled-trials.com (http://www.controlled-trials. com/ISRCTN35739639). International Standard Randomized Controlled Trial Number (ISRCTN): 35739639. Registration date: 5 October 2005. TRIAL DESIGN: parallel randomized trial.

Prevention of diabetes with Mediterranean diets: a subgroup analysis of a randomized trial.

BACKGROUND: Interventions promoting weight loss can reduce the incidence of type 2 diabetes mellitus. Whether dietary changes without calorie restriction also protect from diabetes has not been evaluated. OBJECTIVE: To assess the efficacy of Mediterranean diets for the primary prevention of diabetes in the Prevención con Dieta Mediterránea trial, from October 2003 to December 2010 (median follow-up, 4.1 years). DESIGN: Subgroup analysis of a multicenter, randomized trial. (Current Controlled Trials: ISRCTN35739639) SETTING: Primary care centers in Spain. PARTICIPANTS: Men and women without diabetes (3541 patients aged 55 to 80 years) at high cardiovascular risk. INTERVENTION: Participants were randomly assigned and stratified by site, sex, and age but not diabetes status to receive 1 of 3 diets: Mediterranean diet supplemented with extra-virgin olive oil (EVOO), Mediterranean diet supplemented with nuts, or a control diet (advice on a low-fat diet). No intervention to increase physical activity or lose weight was included. MEASUREMENTS: Incidence of new-onset type 2 diabetes mellitus (prespecified secondary outcome). RESULTS: During follow-up, 80, 92, and 101 new-onset cases of diabetes occurred in the Mediterranean diet supplemented with EVOO, Mediterranean diet supplemented with mixed nuts, and control diet groups, respectively, corresponding to rates of 16.0, 18.7, and 23.6 cases per 1000 person-years. Multivariate-adjusted hazard ratios were 0.60 (95% CI, 0.43 to 0.85) for the Mediterranean diet supplemented with EVOO and 0.82 (CI, 0.61 to 1.10) for the Mediterranean diet supplemented with nuts compared with the control diet. LIMITATIONS: Randomization was not stratified by diabetes status. Withdrawals were greater in the control group. CONCLUSION: A Mediterranean diet enriched with EVOO but without energy restrictions reduced diabetes risk among persons with high cardiovascular risk. PRIMARY FUNDING SOURCE: Instituto de Salud Carlos III.