Effect of including a dietary supplement of raisins, a food rich in polyphenols, on cognitive function in healthy older adults; a study protocol for a randomized clinical trial.

BACKGROUND: Polyphenols have been shown to be effective against many chronic diseases, including neurodegenerative diseases. Specifically, the consumption of raisins, being a food rich in polyphenols, has been attributed with neuroprotective benefits. Therefore, our main objective is to evaluate the effect of including 50 g of raisins in the diet daily for 6 months, on the improvement of cognitive performance, cardiovascular risk factors and markers of inflammation in a population of older adults without cognitive impairment. METHODS: Design and intervention: This study will be a randomized controlled clinical trial of two parallel groups. Each subject included in the study will be randomly assigned to one of two study groups: control group (no supplement), intervention group (50 g of raisins daily during 6 months). STUDY POPULATION: The participants will be selected by consecutive sampling in the Primary Care consultations of urban health centers in Salamanca and Zamora (Spain), taking into account the selection criteria. STUDY VARIABLES: Two visits will be made, baseline and at 6 months. Cognitive performance will be evaluated (Mini-Mental State Examination test, Rey Auditory Verbal Learning Test, verbal fluency and montreal cognitive assessment (Moca)). It will also be analyzed the level of physical activity, quality of life, activities of daily living, energy and nutritional composition of the diet, body composition, blood pressure, heart rate, markers of inflammation and other laboratory tests of clinical relevance (glycaemia, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides). In addition, sociodemographic data, personal and family history, medication use and alcohol and tobacco consumption will be collected. DISCUSSION: In this project, it is intended to contribute to minimize the problems derived from cognitive deterioration in older people. TRIAL REGISTRATION: ClincalTrials.gov Identifier: NCT04966455 Registration date: July 1, 2021.

Retinal blood vessel calibre and vascular ageing in a general Spanish population: A EVA study.

INTRODUCTION: The aim of this work was to analyse the association of the retinal arteriolar calibre and the arteriole/venule index (AV index) with vascular ageing in a general population without previous cardiovascular disease. MATERIALS AND METHODS: Descriptive cross-sectional study. A total of 482 individuals without cardiovascular disease (mean age: 55.6 ± 14.2 years) were selected by random sampling, stratified by age and sex. The retinal arteriolar calibre was measured using digital fundus images of the back of the eye captured with a validated, semiautomatized and computer-assisted software (Index calculator). Vascular ageing was defined using three criteria based on the values of: (1) Carotid-femoral Pulse Wave Velocity (cfPWV), (2) Brachial-ankle Pulse Wave Velocity (baPWV) and (3) Carotid Intima-Media Thickness. RESULTS: The AV index and arteriolar calibre show a negative correlation with age, arterial pressure, cardiovascular risk and parameters of vascular structure and function (p < 0.001 in all cases). We found lower mean values of the AV index and arteriolar calibre in the individuals with early vascular ageing compared to those with healthy vascular ageing. AV index was negatively correlated with cfPWV ((ß=-2.9; 95% CI (-4.7; -1.1)), baPWV ((ß=-3.2; 95% CI (-5.4; -0.9)) and vascular ageing index ((ß=-1.7; 95% CI (-2.7; -0.7)). Arteriolar calibre showed a negative correlation with baPWV (ß=-0.1; 95% CI (-0.2; -0.1)). In the logistic regression analysis, lower values of AV index ((OR=0.01; 95% CI (0.01-0.10), OR=0.03; 95% CI (0.01-0.11) and OR=0.09; 95% CI (0.01-0.67)) were associated with EVA defined with cfPWV, baPWV and vascular ageing index respectively, and lower values of arteriolar calibre ((OR=0.71; 95% CI (0.55-0.91)) were associated with EVA defined with vascular ageing index. CONCLUSIONS: Lower values of AV index and retinal arteriolar calibre were associated with vascular ageing in a general Spanish population without previous cardiovascular disease.

Effects of cocoa-rich chocolate on cognitive performance in postmenopausal women. A randomised clinical trial.

OBJECTIVES: The aim of this research was to evaluate the effects of adding 10 g of cocoa-rich chocolate (99%) to the habitual diet on cognitive performance in postmenopausal women. METHODS: Following a randomised controlled parallel clinical trial, a total of 140 postmenopausal women aged 50-64 were recruited. The intervention group (n = 73) consumed daily 10 g of chocolate (99% cocoa) in addition to their usual food intake for 6 months, whereas the control group (n = 67) did not receive any intervention. Attention and executive functions, verbal memory, working memory, phonological fluency, category fluency and clinical variables were assessed at baseline and 6 months. RESULTS: Trail Making Test B execution time showed a decreased of -12.08 s (95% CI: -23.99, -0.18; p = 0.047) in the intervention group compared to the control group, after adjusting for age, educational level, time elapsed from the beginning of menopause and daily energy consumption (Cohen's d = -0.343). Attention, immediate or delayed verbal memory, phonological or category fluency, and working memory remained unchanged. CONCLUSIONS: The consumption of cocoa-rich (99%) chocolate in addition to the habitual diet could be related to a slight improvement in cognitive performance regarding cognitive flexibility and processing speed in postmenopausal women, with no changes in the rest of the cognitive performance variables evaluated.Trial registration: This clinical trial has been registered at clinicaltrials.gov as NCT03492983.

Changes in lifestyles, cognitive impairment, quality of life and activity day living after combined use of smartphone and smartband technology: a randomized clinical trial (EVIDENT-Age study).

BACKGROUND: The aim of this study was to assess the efficacy of the combined use of smartphone and smartband technology for 3-months alongside brief lifestyle counselling, versus counselling alone, in increasing physical activity. As secondary objectives, the effects of the intervention on dietary habits, body composition, quality of life, level of functionality and cognitive performance were assessed. METHODS: This study employed a randomized clinical trial of two-parallel groups design - control group (CG) and intervention group (IG). The study was conducted in 3 Spanish health-centres between October 2018-February 2020. Eligible participants were people of both sexes and aged between 65-80 years attending the health-centres with a score ≥ 24 points on the Mini-Mental State Examination. Key variables included physical activity, dietary pattern, body composition, cognitive performance, level of functionality and quality of life. All variables were measured at baseline and after 3-months. Both groups received a brief nutritional and physical activity advice. Intervention group participants were instructed to use a smartphone application for a period of 3-months. This application integrates information on physical activity received from a fitness bracelet and self-reported information on the patient's daily nutritional composition. RESULTS: The study population comprised 160 participants (IG = 81, CG = 79), with a mean age of 70.8 ± 4.0 years (61.3% women). No difference was found in the primary and secondary outcomes analyzed (physical activity (steps/min -0.4 (-1.0 to 0.2) p = 0.174), and dietary habits (Mediterranean diet score 0.0 (-0.6 to 0.6) p = 0.956) that could be attributed to either group after an ANCOVA test. A difference attributable to the intervention was observed in the total Clock test score (0.7 (0.1 to 1.2) p = 0.018. CONCLUSIONS: In a sample of people over 65 years of age, the combined use of the EVIDENT 3 smartphone app and an activity tracking bracelet for 3-months did not result in lifestyles changes related to the amount and level of physical activity or the eating habits, compared to brief lifestyle advice. Other clinical parameters were not changed either, although at the cognitive level, a slight improvement was observed in the score on the Clock test assessing a variety of cognitive functions such as memory. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov Identifier: NCT03574480. Date of trial Registration 02/07/2018.

Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial.

BACKGROUND: The present study describes the effectiveness of a complex intervention that addresses multiple lifestyles to promote healthy behaviours in increasing adherence to the Mediterranean diet (MD).  METHODS: Cluster-randomised, hybrid clinical trial controlled with two parallel groups. The study was carried out in 26 primary Spanish healthcare centres. People aged 45-75 years who presented at least two of the following criteria were included: smoker, low adherence to the MD or insufficient level of physical activity. The intervention group (IG) had three different levels of action: individual, group, and community, with the aim of acting on the behaviours related to smoking, diet and physical activity at the same time. The individual intervention included personalised recommendations and agreements on the objectives to attain. Group sessions were adapted to the context of each healthcare centre. The community intervention was focused on the social prescription of resources and activities performed in the environment of the community of each healthcare centre. Control group (CG) received brief advice given in the usual visits to the doctor's office. The primary outcome was the change, after 12 months, in the number of participants in each group with good adherence to the MD pattern. Secondary outcomes included the change in the total score of the MD adherence score (MEDAS) and the change in some cardiovascular risk factors. RESULTS: Three thousand sixty-two participants were included (IG = 1,481, CG = 1,581). Low adherence to the MD was present in 1,384 (93.5%) participants, of whom 1,233 initiated the intervention and conducted at least one individual visit with a healthcare professional. A greater increase (13.7%; 95% CI, 9.9-17.5; p < 0.001) was obtained by IG in the number of participants who reached 9 points or more (good adherence) in the MEDAS at the final visit. Moreover, the effect attributable to the intervention obtained a greater increase (0.50 points; 95% CI, 0.35 to 0.66; p < 0.001) in IG. CONCLUSIONS: A complex intervention modelled and carried out by primary healthcare professionals, within a real clinical healthcare context, achieved a global increase in the adherence to the MD compared to the brief advice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03136211. Retrospectively registered on 02/05/2017 https://clinicaltrials.gov/ct2/show/NCT03136211.

Long-term Effectiveness of a Smartphone App Combined With a Smart Band on Weight Loss, Physical Activity, and Caloric Intake in a Population With Overweight and Obesity (Evident 3 Study): Randomized Controlled Trial.

BACKGROUND: Multicomponent mobile health approaches can improve lifestyle intervention results, although little is known about their long-term effectiveness. OBJECTIVE: This study aims to evaluate the long-term effectiveness (12 months) of a multicomponent mobile health intervention-combining a smartphone app, an activity tracker wristband, and brief counseling, compared with a brief counseling group only-on weight loss and improving body composition, physical activity, and caloric intake in Spanish sedentary adults with overweight or obesity. METHODS: We conducted a randomized controlled, multicenter clinical trial (Evident 3). A total of 650 participants were recruited from 5 primary care centers, with 318 participants in the intervention group (IG) and 332 in the control group (CG). All participants were briefly counseled about a healthy diet and physical activity at the baseline visit. For the 3-month intervention period, the IG received training to use the app to promote healthy lifestyles and the smart band (Mi Band 2, Xiaomi). All measurements were performed at baseline and at 3 and 12 months. Physical activity was measured using the International Physical Activity Questionnaire-Short Form. Nutritional habits were assessed using the Food Frequency Questionnaire and Adherence to Mediterranean diet questionnaire. RESULTS: Of the 650 participants included, 563 (86.6%) completed the 3-month visit and 443 (68.2%) completed the 12-month visit. After 12 months, the IG showed net differences in weight (-0.26, 95% CI -1.21 to 0.70 kg; P=.02), BMI (-0.06, 95% CI -0.41 to 0.28 points; P=.01), waist-height ratio (-0.25, 95% CI -0.94 to 0.44; P=.03), body adiposity index (-0.33, 95% CI -0.77 to 0.11; P=.03), waist circumference (-0.48, 95% CI -1.62 to 0.66 cm, P=.04) and hip circumference (-0.69, 95% CI -1.62 to 0.25 cm; P=.03). Both groups lowered daily caloric intake and increased adherence to the Mediterranean diet, with no differences between the groups. The IG increased light physical activity time (32.6, 95% CI -30.3 to 95.04 min/week; P=.02) compared with the CG. Analyses by subgroup showed changes in body composition variables in women, people aged >50 years, and married people. CONCLUSIONS: The low-intensity intervention of the Evident 3 study showed, in the IG, benefits in weight loss, some body composition variables, and time spent in light physical activity compared with the CG at 3 months, but once the devices were collected, the downward trend was not maintained at the 12-month follow-up. No differences in nutritional outcomes were observed between the groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1097/MD.0000000000009633.

Cocoa-rich chocolate and body composition in postmenopausal women: a randomised clinical trial.

During menopause, women undergo a series of physiological changes that include a redistribution of fat tissue. This study was designed to investigate the effect of adding 10 g of cocoa-rich chocolate to the habitual diet of postmenopausal women daily on body composition. We conducted a 6-month, two-arm randomised, controlled trial. Postmenopausal women (57·2 (sd 3·6) years, n 132) were recruited in primary care clinics. Participants in the control group (CG) did not receive any intervention. Those of the intervention group (IG) received 10 g daily of 99 % cocoa chocolate in addition to their habitual diet for 6 months. This quantity comprises 247 kJ (59 kcal) and 65·4 mg of polyphenols. The primary outcomes were the between-group differences in body composition variables, measured by impendancemetry at the end of the study. The main effect of the intervention showed a favourable reduction in the IG with respect to the CG in body fat mass (-0·63 kg (95 % CI -1·15, -0·11), P = 0·019; Cohen's d = -0·450) and body fat percentage (-0·79 % (95 % CI -1·31, -0·26), P = 0·004; Cohen's d = -0·539). A non-significant decrease was also observed in BMI (-0·20 kg/m2 (95 % CI -0·44, 0·03), P = 0·092; Cohen's d = -0·345). Both the body fat mass and the body fat percentage showed a decrease in the IG for the three body segments analysed (trunk, arms and legs). Daily addition of 10 g of cocoa-rich chocolate to the habitual diet of postmenopausal women reduces their body fat mass and body fat percentage without modifying their weight.

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial.

BACKGROUND: This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45-75 years compared to usual care; and b) an implementation strategy. METHODS: A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. RESULTS: 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. CONCLUSIONS: Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

The Relationship Between Alcohol Consumption With Vascular Structure and Arterial Stiffness in the Spanish Population: EVA Study.

BACKGROUND: Controversy exists regarding the way alcohol use is associated with vascular structure and arterial stiffness parameters. The purpose of this study is to evaluate the association between alcohol consumption with vascular structure and arterial stiffness in an adult population. METHODS: We conducted a cross-sectional study. Five hundred and one participants were recruited by random sampling from an urban population of 43,946 individuals aged 35 to 75 years, assigned from 5 healthcare centers located in Salamanca, Spain. This was a subanalysis of the EVA study. Arterial stiffness was assessed by measuring cardio-ankle vascular index (CAVI) and brachial-ankle pulse wave velocity (ba-PWV) with the VaSera VS-1500® device, and carotid-femoral pulse wave velocity (cf-PWV) with the Sphygmocor® . Vascular structure was evaluated by measuring the carotid intima-media thickness (c-IMT) with a Sonosite Micromax® ultrasound. Alcohol consumption was calculated using a standardized questionnaire and quantified in g/wk. RESULTS: In the multiple regression analysis adjusted for sex, age, smoking status, and systolic blood pressure, the c-IMT and cf-PWV values of individuals drinking > 70 g/wk were higher than those of the reference group (nondrinkers) by 0.02 mm (p = 0.030) and 0.42 m/s (p = 0.021), respectively. The association between alcohol consumption with vascular structure and arterial stiffness only attains statistical significance for cf-PWV (p = 0.039) and c-IMT (p = 0.019), showing an association which suggests a J-shaped association. This association was not statistically significant for ba-PWV and CAVI (p = 0.446 and p = 0.141, respectively), although a similar trend was observed with ba-PWV. CONCLUSIONS: The results of this study suggest that heavy alcohol consumption (>70 g/wk) is associated with increased c-IMT and cf-PWV. Moreover, we found a J-shaped association between alcohol consumption and c-IMT and cf-PWV values as markers of vascular structure and arterial stiffness, with no association with ba-PWV and CAVI being observed.

Postprandial effects of breakfast glycaemic index on cognitive performance among young, healthy adults: A crossover clinical trial.

Objective: To evaluate the postprandial effects of high and low glycaemic index (GI) breakfasts on cognitive performance in young, healthy adults.Methods: A crossover clinical trial including 40 young, healthy adults (aged 20-40 years, 50% females) recruited from primary healthcare centres in Salamanca, Spain. Verbal memory, phonological fluency, attention, and executive functions were examined 0, 60, and 120 minutes after consuming a low GI (LGI), high GI (HGI), or water breakfast. Every subject tried each breakfast variant, in a randomized order, separated by a washout period of 7 days, for a total of 3 weeks.Results: A significant interaction between the type of breakfast consumed and immediate verbal memory was identified (P<.05). We observed a trend towards better performance in verbal memory (delayed and immediate), attention, and phonological fluency following an LGI breakfast.Discussion: Cognitive performance during the postprandial phase in young, healthy adults was minimally affected by the GI of breakfast. The potential for breakfast's GI modulation to improve short- and long-term cognitive functioning requires further research.

Acute effect of healthy walking on arterial stiffness in patients with type 2 diabetes and differences by age and sex: a pre-post intervention study.

BACKGROUND: Daily aerobic exercise such as healthy walking could have an immediate effect on parameters of arterial stiffness; however, there is little evidence in the diabetic population. Our aim, therefore, is to evaluate the association between healthy walking and acute effects on the parameters of arterial stiffness in subjects with type 2 diabetes. METHODS: The Effectiveness of a multifactorial intervention in diabetics study (EMID), is a study based on an application for smartphones, healthy walking and a nutritional workshop in patients with type 2 diabetes in primary care, is a randomized controlled trial of two parallel groups. This is a subanalysis of the intervention group to evaluate the response to the healthy walking according to age and sex, in 89 subjects with type 2 diabetes, aged between 40 and 70 years. The intervention was a 4 km of a healthy walking at low-moderate intensity. To value our aim, the main study variables were measured before and after it. RESULTS: The study population had an average age of 65.0 years (61.2-68.1). After the healthy walking, there was a decrease in the parameters of arterial stiffness: Cardio ankle vascular index (CAVI) of - 0.2 (95%CI:-0.4 to - 0.1) and pulse pressure (PP) of the lower extremities of - 3.9 mmHg (95%CI: -5.9 to - 2.0). Furthermore, in the lower extremities there was a decrease in systolic blood pressure of - 5.3 mmHg (95% CI: -7.3 mmHg to - 3.3 mmHg), in diastolic blood pressure of - 1.5 mmHg (95% CI: -2.6 mmHg to - 0.4 mmHg) (p < 0.05 for all). It is observed that males have an OR of 2.981 (IC = 95% 1.095 to 8.119) to achieve a reduction in the CAVI (p < 0.05) and an OR of 2.433 (95%CI: 0.871 to 6.794) in the ankle PP (p > 0.05), compared with females. CONCLUSIONS: The findings of this study suggest that daily aerobic exercise at a low to moderate intensity, such as healthy walking, has an immediate beneficial effect on the cardio-ankle vascular index, especially in males. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02991079 .

Combined use of smartphone and smartband technology in the improvement of lifestyles in the adult population over 65 years: study protocol for a randomized clinical trial (EVIDENT-Age study).

BACKGROUND: The increasing use of smartphones by older adults also increases their potential for improving different aspects of health in this population. Some studies have shown promising results in the improvement of cognitive performance through lifestyle modification. All this may have a broad impact on the quality of life and carrying out daily living activities. The objective of this study is to evaluate the effectiveness of combining the use of smartphone and smartband technology for 3 months with brief counseling on life habits, as opposed to providing counseling only, in increasing physical activity and improving adherence to the Mediterranean diet. Secondary objectives are to assess the effect of the intervention on body composition, quality of life, independence in daily living activities and cognitive performance. METHODS: This study is a two-arm cluster-randomized trial that will be carried out in urban health centers in Spain. We will recruit 160 people aged between 65 and 80 without cardiovascular disease or cognitive impairment (score in the Mini-mental State Examination ≥24). On a visit to their center, intervention group participants will be instructed to use a smartphone application for a period of 3 months. This application integrates information on physical activity received from a fitness bracelet and self-reported information on the patient's daily nutritional composition. The primary outcome will be the change in the number of steps measured by accelerometer. Secondary variables will be adherence to the Mediterranean diet, sitting time, body composition, quality of life, independence in daily living activities and cognitive performance. All variables will be measured at baseline and on the assessment visit after 3 months. A telephone follow-up will be carried out at 6 months to collect self-reported data regarding physical activity and adherence to the Mediterranean diet. DISCUSSION: Preventive healthy aging programs should include health education with training in nutrition and lifestyles, while stressing the importance of and enhancing physical activity; the inclusion of new technologies can facilitate these goals. The EVIDENT-AGE study will incorporate a simple, accessible intervention with potential implementation in the care of older adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03574480 . Date of trial Registration July 2, 2018.

Effectiveness of an intensive intervention to improve lifestyles in people with intermediate cardiovascular risk (DATE study): Study protocol for a randomized controlled trial.

AIM: The aim of this study was to evaluate the effectiveness of an intensive intervention led by primary care nurses for lifestyle modification among people with intermediate cardiovascular risk. BACKGROUND: Cardiovascular diseases may be prevented by adopting healthy lifestyles. Interventions focused on populations at risk are more efficient than those aimed at the general population. More than 50 per cent of cardiovascular events occur in people with intermediate cardiovascular risk, but only a few studies have targeted this population. DESIGN: A randomized controlled trial approved in January 2017. METHODS: We will recruit 208 participants aged 35-74 years who have intermediate cardiovascular risk. They will be selected by consecutive sampling and will be randomized into a control group or intervention group. Individual standardized brief counselling on healthy lifestyles will be provided to both groups. Additionally, individuals from the intervention group will receive four weekly group sessions focusing on cardiovascular risk, healthy diet, moderation in alcohol consumption, daily physical activity, stress management and smoking cessation and two motivational follow-up calls. The primary outcome will be the lifestyle modification measured by total steps recorded by a pedometer, total score on the Mediterranean Diet Adherence Screener and percentage of current smokers. DISCUSSION: This study will allow us to investigate whether an intensive intervention based on a multifactorial group approach is more effective in lifestyle modification than individual standardized brief counseling among adults with intermediate cardiovascular risk. Our results could lead to the establishment of new strategies for cardiovascular risk management.

The EVIDENT diet quality index is associated with cardiovascular risk and arterial stiffness in adults.

BACKGROUND: We aimed to simplify information from food frequency questionnaires (FFQs) in a single parameter that allows for rapid identification of quality of patient diet and its relationship to cardiovascular risk and pulse wave velocity (PWV). METHODS: The sample from the EVIDENT study, consisting of 1553 subjects (aged 20-80 years) with no cardiovascular disease selected by random sampling among those attending primary care clinics, was used. The EVIDENT diet index (range 0-100) was calculated based on the results of a FFQ. Evaluation of dietary habits also included adherence to the Mediterranean diet (MD). Cardiovascular risk was estimated, and carotid-femoral pulse wave velocity was measured. RESULTS: Mean subject age was 54.9 ± 13.8 years, and 60.3% of subjects were female. The mean value of the EVIDENT diet index was 52.1 ± 3.2 points. Subjects in the third tertile (the highest score) had the greatest adherence to MD and the highest energy intake, with greater amounts of carbohydrates, protein, and fiber. The best cut-off point of the EVIDENT diet index for predicting good adherence to the MD is 52.3 (0.71 sensitivity, 0.61 specificity). In a multiple regression analysis, after a complete adjustment, it was estimated that for each one-point increase in the EVIDENT diet index, cardiovascular risk (CVR), blood-pressure, waist circumference, and PWV decreased by 0.14, 0.43, 0.24, and 0.09 respectively (p < 0.05, all). CONCLUSIONS: The diet quality index developed is associated to CVR and its components, and also with arterial stiffness, as measured with PWV. This index is also a good predictor of adherence to MD.

Physical Activity and Adiposity Among Older Adults of the EVIDENT Study.

This study determined the relationship between self-reported and objective measurements of physical activity with adiposity markers in a random sample of community-dwelling older adults. The sample included 439 individuals over 65 years (age 71.1 ± 7.8; 54.2% women). Regular physical activity information was collected using self-reported (questionnaire, 7-day-PAR) and objective measurements (accelerometer ActiGraph GT3X) over 7 days. Anthropometric parameters included body mass index, body fat percentage, and waist circumference. The number of patients considered active was 28% according to the results of 7-day PAR, and 69% according to objective measures of accelerometry. With every daily increase of 10 min of sedentary activity, the BMI, body fat percentage, and waist circumference values increased by 0.04 units, 0.14%, and 0.14 cm, respectively. According to the accelerometry data, being active was a protective factor for presenting obesity criteria (OR = 0.34, CI 95% 0.19-0.59). Objective but non self-reported physical activity was associated with adiposity markers in older adults.

Association of metabolic syndrome and its components with arterial stiffness in Caucasian subjects of the MARK study: a cross-sectional trial.

BACKGROUND: The cardio-ankle vascular index (CAVI) and brachial-ankle pulse wave velocity (baPWV) can reflect both central and peripheral arterial stiffness. Metabolic syndrome (MetS) and its components may increase arterial stiffness and the risk of cardiovascular diseases. However, the correlation of MetS and its components with arterial stiffness is still not clear. The primary aim of this study is thus the relationship using baPWV and CAVI in Caucasian adults with intermediate cardiovascular risk. The secondary aim is to analyze sex differences. METHODS: This study analyzed 2351 subjects aged 35-74 years (mean, 61.4 ± 7.7 years) comprising 61.7 % males and enrolled in the improving interMediAte Risk management (MARK) study. CAVI was measured using a VaSera VS-1500 ® device, and baPWV was calculated using a validated equation. MetS was defined based on the Joint Scientific Statement National Cholesterol Education Program III. Waist circumference, blood pressure, fasting plasma glucose, and lipid profile were measured. RESULTS: MetS was found in 51.9 % of the subjects. All MetS components except reduced HDL-cholesterol (p = 0.578) were associated with CAVI. High density lipoprotein cholesterol (p = 0.075) and waist circumference (p = 0.315) were associated with baPWV. The different MetS components that assess dyslipidemia using the stiffness measures show different associations according to patient sex. The high blood pressure component had a greater odds ratio (OR) for both baPWV ≥ 17.5 m/sec (OR = 6.90, 95 % CI 3.52-13.519) and CAVI ≥ 9 (OR = 2.20, 95 % CI 1.63-1.90). CONCLUSIONS: MetS and all its components (except HDL-cholesterol with baPWV and CAVI and WC with baPWV) were associated with baPWV and CAVI. However, there were sex differences in the association of MetS and its components with baPWV and CAVI. Data from this study suggest a greater association of CAVI and baPWV values with MetS components in males than in females and indicate greater arterial stiffness in the event of simultaneously elevated blood pressure, fasting plasma glucose, and waist circumference. Trial Registration Clinical Trials.gov Identifier: https://clinicaltrials.gov/ct2/show/ NCT01428934. Registered 2 September 2011. Last updated September 8, 2016.

Abdominal obesity as a mediator of the influence of physical activity on insulin resistance in Spanish adults.

OBJECTIVE: The aim of the study was to analyze the relationship between moderate-to-vigorous physical activity (MVPA) and insulin resistance (IR) in Spanish adults and to examine whether this relationship is mediated by abdominal obesity (waist circumference - WC). METHODS: The cross-sectional study included 1162 healthy subjects belonging to the EVIDENT study (mean age 55.0±13.3years; 61.8% women) from six different Spanish provinces. Moderate-to-vigorous physical activity (MVPA) was measured objectively over 7days using Actigraph accelerometers, collecting data in 60-second epochs, and retaining respondents with ≥4 valid days for the analysis. The homeostasis model of assessment (HOMA-IR) was used to determine IR, and its individual components - fasting glucose and insulin - were determined using standard protocols. Linear regression models were fitted according to Baron and Kenny's procedures for mediation analysis. RESULTS: Fasting insulin and HOMA-IR levels were significantly worse in adults who spent fewer minutes in MVPA (first quartile≤30.1 and 22.7min/day in men and women, respectively) after adjusting for age, sex, smoking habits, drinking habits, accelerometer wear time, sedentary time, and Mediterranean diet adherence. However, when WC was added to the ANCOVA models as a covariate, the effects disappeared. Mediation analysis reported that WC acts as a full mediator in the relationship between MVPA and IR (HOMA-IR and fasting insulin). CONCLUSION: These findings show that WC plays a pivotal role in the relationship between MVPA and IR, and therefore highlights that decreasing abdominal obesity might be considered as an intermediate outcome for evaluating interventions aimed at preventing diabetes mellitus.

Diet and physical activity in people with intermediate cardiovascular risk and their relationship with the health-related quality of life: results from the MARK study.

BACKGROUND: To analyze the interplay between diet, physical activity and health-related quality of life in a Spanish randomly selected sample of individuals attended in general practitioners offices with intermediate cardiovascular risk. METHODS: This study analyzed 314 subjects, aged 35-74 years (50.6% women), from the MARK study, conducted in Spain. Health related quality of life was measured by the SF-12 questionnaire. The assessment of the lifestyles included the diet quality index, the adherence to the Mediterranean diet and the leisure time physical activity practice. RESULTS: The highest values of health related quality of life were obtained in the area of vitality (51.05 ± 11.13), while the lowest were found in the general health (39.89 ± 8.85). In the multiple linear regression analysis, after adjustment for age, gender and other confounders, for each point of increase in the Mediterranean diet adherence score, there was an increase of 1.177 points in the mental component value (p < 0.01). Similarly, for each point of increase in the Diet Quality Index Score, there was an increase in the mental component of 0.553 (p < 0.05). Likewise, the physical activity was positively associated with the physical function and vitality (ß = 0.090 and 0.087, (p < 0.01 and p < 0.05), respectively). CONCLUSIONS: In people with intermediate cardiovascular risk, better food habits and greater adherence to the Mediterranean diet are associated with higher scores on the mental component of quality of life. Likewise, increased physical activity is related with positive scores on the physical function.

Vascular structure and function and their relationship with health-related quality of life in the MARK study.

BACKGROUND: There is limited evidence concerning the relationship between vascular disease and health-related quality of life (HRQL). We investigated the relationship between vascular structure and function with health-related quality of life in a population with intermediate cardiovascular risk. METHODS: This study analyzed 303 subjects with ankle-brachial index (ABI) values ranging from 0.9 to 1.4 who were included in the MARK study (age 35 to 74 years; mean:60.5 ± 8.5), of which 50.2 % were women. Measurements included: ABI, brachial-ankle pulse wave velocity (ba-PWV), and cardio-ankle vascular index (CAVI), all measured using the VaSera device. The central augmentation index was adjusted to 75 lpm (AIx_75) using the Mobil-O-Graph device. HRQL was assessed by the Spanish version of the SF-12, version2. The highest obtained CAVI and ba-PWV values and the lowest ABI values were considered for the study. RESULTS: The cohort was composed of21 % smokers, 76 % hypertensive patients, and 24 % diabetic patients. The ABI mean was 1.09 ± 0.07,the ba-PWV mean was 14.64 ± 2.55 m/s with a 12.9 % of subjects higher than 17.5 m/s, AIx_75 26.46 ± 14.05, and CAVI 8.61 ± 1.08 with a 36.6 % of subjects higher than 9. Men scored higher than women in the HRQL measurements for physical (PSC-12; 49.9 vs. 46.9, p = 0.004) and mental (MSC-12) domains (51.2 vs. 47.7, p = 0.003). Age was positively correlated with CAVI (r = 0.547), ba-PWV (r = 0.469), AIx_75 (r = 0.255, p < 0.01), and the MSC-12 (r = 0.147, p < 0.05), but not the PSC-12. In the adjusted multiple linear regression analysis, the positive association of ABI and CAVI with the PSC-12 was maintained. CONCLUSIONS: The ABI in the normal range has a positive association with the PSC-12 of HRQL evaluated with the SF-12. The CAVI also showed a positive association with the PSC-12 of HRQL. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01428934 .

Association between markers of glycemia and carotid intima-media thickness: the MARK study.

BACKGROUND: Carotid intima-media thickness (C-IMT) is a reliable predictor of cardiovascular events. We Investigated the relationship between markers of glycemia and C-IMT in intermediate-risk cardiovascular patients. METHODS: This study analyzed 427 subjects, aged 35 to 74 years (mean, 60.3 ± 8.5 years), 55 % women, enrolled into the MARK study. Including 231 subjects defined as normal glucose, 104 subjects classified as prediabetes and 92 with type 2 diabetes mellitus. Carotid ultrasound was used to measure C-IMT and the presence of plaques. Fasting plasma glucose (mg/dl) and glycated hemoglobin (%) (HbA1c) were measured using standard enzymatic automated methods. Postprandial glucose (mg/dl) was self-measured by patients at home 2 h after meals (breakfast, lunch and dinner) for 1 day. RESULTS: The C-IMT shows a positive correlation with fasting plasma glucose, postprandial glucose and HbA1c. Multiple linear regression analysis showed a positive association between HbA1c and C-IMT, with a 0.016 mm and 0.019 mm increase in mean and maximum C-IMT per 1 % increase in HbA1c. In addition, an association between fasting plasma glucose and C-IMT was found with an increase of 0.004 and 0.005 mm in mean and maximum C-IMT per 10 mg/dl in fasting plasma glucose. We also observed a graded association between fasting plasma glucose, postprandial glucose and HbA1c and the presence of carotid target organ damage (TOD), with an odds ratio of 1.013, 1.010 and 1.425, respectively. CONCLUSION: The results of this study suggest that the fasting plasma glucose and HbA1c, but not postprandial glucose, are associated with C-IMT media and maximum. The patients who present with a metabolic glucose alteration have more risk of developing carotid TOD. TRIAL REGISTRATION: ClinicalTrials.gov; Identifier: NCT01428934 .