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This report includes the reanalysis of data from a clinical trial showing a lower rate of cardiovascular events among persons assigned to a Mediterranean diet supplemented with extra-virgin olive oil or nuts than among those assigned to a low-fat diet.

Benzodiazepines are extensively used in primary care, but their long-term use is associated with adverse health outcomes and dependence. To analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use. A multicentre three-arm cluster randomised controlled trial was conducted, with randomisation at general practitioner level (trial registration ISRCTN13024375). A total of 532 patients taking benzodiazepines for at least 6 months participated. After all patients were included, general practitioners were randomly allocated (1:1:1) to usual care, a structured intervention with follow-up visits (SIF) or a structured intervention with written instructions (SIW). The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription claims at 12 months. At 12 months, 76 of 168 (45%) patients in the SIW group and 86 of 191 (45%) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 (15%) in the control group. After adjusting by cluster, the relative risks for benzodiazepine discontinuation were 3.01 (95% CI 2.03-4.46, P<0.0001) in the SIW and 3.00 (95% CI 2.04-4.40, P<0.0001) in the SIF group. The most frequently reported withdrawal symptoms were insomnia, anxiety and irritability. Both interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity. A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits.

Aims/hypothesis To assess the feasibility and effectiveness of an active real-life primary care lifestyle intervention in preventing type 2 diabetes within a high-risk Mediterranean population. Methods A prospective cohort study was performed in the setting of Spanish primary care. White-European individuals without diabetes aged 45–75 years ( n  = 2,054) were screened using the Finnish Diabetes Risk Score (FINDRISC) and a subsequent 2 h OGTT. Where feasible, high-risk individuals who were identified were allocated sequentially to standard care, a group-based or an individual level intervention (intensive reinforced DE-PLAN [Diabetes in Europe—Prevention using Lifestyle, Physical Activity and Nutritional] intervention). The primary outcome was the development of diabetes according to WHO criteria. Analyses after 4-year follow-up were performed based on the intention-to-treat principle with comparison of standard care and the combined intervention groups. Results The standard care ( n  = 219) and intensive intervention ( n  = 333) groups were comparable in age (62.0/62.2 years), sex (64.4/68.2% women), BMI (31.3/31.2 kg/m 2 ), FINDRISC score (16.2/15.8 points), fasting (5.3/5.2 mmol/l), 2 h plasma glucose (7.1/6.9 mmol/l) and self-reported interest to make lifestyle changes at baseline. Diabetes was diagnosed in 124 individuals: 63 (28.8%) in the standard care group and 61 (18.3%) in the intensive intervention group. During a 4.2-year median follow-up, the incidences of diabetes were 7.2 and 4.6 cases per 100 person-years, respectively (36.5% relative risk reduction, p  < 0.005). The number of participants needed to be treated by intensive intervention for 4 years to reduce one case of diabetes was 9.5. Conclusions/interpretation Intensive lifestyle intervention is feasible in a primary care setting and substantially reduces diabetes incidence among high-risk individuals. Clinical trial registration: ClinicalTrial.gov NCT01519505 Funding: Commission of the European Communities, Institute of Health Carlos III, Spanish Ministry of Health and Department of Health, Generalitat de Catalunya.

Background:Epidemiological studies and feeding trials with supplements suggest that fibre intake is associated with a reduction in cardiovascular risk. However, the effects of changes in dietary fibre on risk factor levels have not been evaluated in free-living individuals. Thus, the effects of changes in dietary fibre intake on cardiovascular risk factors were assessed over 3 months in free-living high-risk subjects.Methods:772 high-risk subjects (age 69±5 years) were assigned to a low-fat diet or two Mediterranean-style diets. All participants received behavioural and nutritional education, including recommendations for increasing the consumption of vegetables, fruits, and legumes. Changes in food and nutrient intake, body weight, blood pressure, lipid profiles, glucose control and inflammatory markers were evaluated.Results:Most participants increased consumption of vegetable products, but the increase in dietary fibre exhibited wide between-subject variability (6–65 g/day). Body weight, waist circumference, and mean systolic and diastolic blood pressure decreased across quintiles of fibre intake (p<0.005; all). Reductions in fasting glucose and total cholesterol levels, and increments in HDL cholesterol were highest among participants in the upper 20% of fibre intake (p = 0.04 and 0.02 respectively). Plasma concentrations of C-reactive protein, but not those of inflammatory cytokines, decreased in parallel with increasing dietary fibre (p = 0.04). Significant reductions in LDL cholesterol were observed only among participants with the greatest increases in soluble fibre intake (p = 0.04).Conclusions:Increasing dietary fibre intake with natural foods is associated with reductions in classical and novel cardiovascular risk factors in a high-risk cohort.

ObjectivesObesity is subject to strong family clustering. The relatives of participants in weight-loss interventions may also modify their lifestyle and lose weight. The aim of this study was to examine the presence and magnitude of a halo effect in untreated family members of participants enrolled in a randomized, multi-component, lifestyle intervention.MethodsA total of 148 untreated adult family members of participants in an intensive weight-loss lifestyle intervention (the PREDIMED-Plus study) were included. Changes at 1 and 2 years in body weight, physical activity, and adherence to a traditional Mediterranean diet (MedDiet) were measured. Generalized linear mixed models were used to assess whether the change differed between family members of the intervention group compared to the control.ResultsUntreated family members from the intervention group displayed a greater weight loss than those from the control after 1 and 2 years: adjusted 2-year weight change difference between groups was −3.98 (SE 1.10) kg (p < 0.001). There was a halo effect with regard to adherence to the MedDiet at one year which was sustained at two years: 2-year adjusted difference in MedDiet score change +3.25 (SE 0.46) (p < 0.001). In contrast, no halo effect was observed with regard to physical activity, as the untreated family members did not substantially modify their physical activity levels in either group, and the adjusted difference at two years between the 2 groups was −272 (SE 624) METs.min/week (p = 0.665).ConclusionsIn the first prospective study to assess the influence on untreated family members of a diet and physical activity weight-loss intervention, we found evidence of a halo effect in relatives on weight loss and improvement in adherence to a MedDiet, but not on physical activity. The expansion of MedDiet changes from individuals involved in a weight-loss intervention to their family members can be a facilitator for obesity prevention.

The aim of the study was to compare the effect of the administration of a mixture of fibres on body weight-loss, satiety, lipid profile and glucose metabolism. We included 200 overweight or obese patients in a parallel, double-blind, placebo-controlled clinical trial, who were randomised to receive, in the context of an energy-restricted diet for a period of 16 weeks, a mixed fibre dose (3 g Plantago ovata husk and 1 g glucomannan) twice (b.i.d. group) or three times daily (t.i.d. group) or placebo. Weight change was the primary efficacy endpoint. Satiety, dietary compliance, lipid profile, glucose tolerance, insulin resistance and high-sensitivity C-reactive protein were secondary endpoints. Weight loss tended to be higher after both doses of fibre ( − 4·52 (sd 0·56) and − 4·60 (sd 0·55) kg) than placebo ( − 0·79 (sd 0·58) kg); the differences in changes between groups were not statistically significant. Postprandial satiety increased in both fibre groups compared to the placebo. The differences between groups in LDL-cholesterol levels were significant (P = 0·03), with greater reductions in the two fibre-supplemented groups ( − 0·38 (sd 0·10) and − 0·24 (sd 0·09) mmol/l in the b.i.d. and t.i.d. groups v. − 0·06 (sd 0·09) mmol/l in placebo group). A similar pattern was observed for changes in total cholesterol:HDL-cholesterol and HDL-cholesterol:LDL-cholesterol ratios. Interventions were well tolerated and had no effects on HDL-cholesterol, glucose and insulin concentrations, glucose tolerance or high-sensitivity C-reactive protein. In conclusion, a 16-week dietary supplement of soluble fibre in overweight or obese patients was well tolerated, induced satiety and had beneficial effects on some CVD risk factors, the most important of which was a significant decrease in plasma LDL-cholesterol concentrations.

The traditional Mediterranean diet is characterized by a high intake of olive oil, fruit, nuts, vegetables, and cereals; a moderate intake of fish and poultry; a low intake of dairy products, red meat, processed meats, and sweets; and wine in moderation, consumed with meals.1 In observational cohort studies2,3 and a secondary prevention trial (the Lyon Diet Heart Study),4 increasing adherence to the Mediterranean diet has been consistently beneficial with respect to cardiovascular risk.2-4 A systematic review ranked the Mediterranean diet as the most likely dietary model to provide protection against coronary heart disease.5 Small clinical trials have uncovered plausible biologic mechanisms to explain the salutary effects of this food pattern.6-9 We designed a randomized trial to test the efficacy of two Mediterranean diets (one supplemented with extra-virgin olive oil and another with nuts), as compared with a control diet (advice on a low-fat diet), on primary cardiovascular prevention.

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

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.

The aim of this study is to determine whether metabolic syndrome, its individual components, or the presence of type 2 diabetes mellitus are associated with a better bone status estimated by quantitative ultrasound at the calcaneus. Cross-sectional study. Outpatient clinics. 251 elderly subjects at high cardiovascular risk from the PREDIMED study were included. MetS was defined according to the ATPIII diagnosis criteria. Calcaneus quantitative ultrasound (QUS) assessment was performed using the Sahara system. Subjects with MetS showed significantly lower 24-hour urinary deoxypyridinoline/creatinine (u-DPD/creatinine) levels and higher broadband ultrasound attenuation, and a tendency to higher bone mineral density (BMD) and quantitative ultrasound index (QUI) than their counterparts. Individuals with type 2 diabetes mellitus (T2DM) showed a significantly higher bone broadband ultrasound attenuation (BUA) and QUI than their non-diabetic counterparts, despite they shown a higher prevalence of osteoporotic fractures. Multiple linear regression analyses showed that quantitative ultrasound parameters were positively associated with the metabolic syndrome and T2DM. Of the bone biochemical markers, only u-DPD/creatinine was related to MetS, abdominal obesity, hypertriglyceridemia component of the MetS, and the number of features that define the MetS. This is the first study showing a positive association between MetS or T2DM with better bone status and lower bone resorption markers measured by quantitative ultrasound. Our results suggest that metabolic abnormalities have a positive effect on healthy bone in elderly subjects at high risk of cardiovascular disease.