Gut microbiota and its relationship with early vascular ageing in a Spanish population (MIVAS study).

BACKGROUND: Gut microbiota and its by-products are increasingly recognized as having a decisive role in cardiovascular diseases. The aim is to study the relationship between gut microbiota and early vascular ageing (EVA). METHODS: A cross-sectional study was developed in Salamanca (Spain) in which 180 subjects aged 45-74 years were recruited. EVA was defined by the presence of at least one of the following: carotid-femoral pulse wave velocity (cf-PWV), cardio-ankle vascular index (CAVI) or brachial-ankle pulse wave velocity (ba-PWV) above the 90th percentile of the reference population. All other cases were considered normal vascular ageing (NVA). MEASUREMENTS: cf-PWV was measured by SphygmoCor® System; CAVI and ba-PWV were determined by Vasera 2000® device. Gut microbiome composition in faecal samples was determined by 16S rRNA Illumina sequencing. RESULTS: Mean age was 64.4 ± 6.9 in EVA group and 60.4 ± 7.6 years in NVA (p < .01). Women in EVA group were 41% and 53% in NVA. There were no differences in the overall composition of gut microbiota between the two groups when evaluating Firmicutes/Bacteriodetes ratio, alfa diversity (Shannon Index) and beta diversity (Bray-Curtis). Bilophila, Faecalibacterium sp.UBA1819 and Phocea, are increased in EVA group. While Cedecea, Lactococcus, Pseudomonas, Succiniclasticum and Dielma exist in lower abundance. In logistic regression analysis, Bilophila (OR: 1.71, 95% CI: 1.12-2.6, p = .013) remained significant. CONCLUSIONS: In the studied Spanish population, early vascular ageing is positively associated with gut microbiota abundance of the genus Bilophila. No relationship was found between phyla abundance and measures of diversity.

Association of Accelerometer-Measured Sedentary Time and Physical Activity with Arterial Stiffness and Vascular Aging in the General Spanish Population, Analyzed by Sex.

Background: In this study we analyzed the association between physical activity and sedentary lifestyle with vascular aging in Spanish populations aged 35-75 years. Methods: A cross-sectional study was developed, in which 501 subjects aged 35-75 years were recruited. Physical activity and sedentary time were measured with an accelerometer (Actigraph GTX3) for a week. We measured carotid-femoral pulse wave velocity (cfPWV) by a Sphygmo Cor® device and carotid intima-media thickness (cIMT) by ultrasound (Sonosite Micromax®). The vascular aging index (VAI) was calculated as described in the literature. Vascular aging was defined considering the 25th and 75th percentiles by age and sex of cfPWV and VAI, presence of vascular injury, type-2 diabetes mellitus or arterial hypertension. Individuals were classified into three groups: healthy, normal, and early vascular aging. Results: The mean age of the sample was 55.90 ± 14.24 years, 50% being women. Total physical activity was negatively associated with cfPWV ( ß = -0.454) and VAI ( ß = -1.845). Similarly, the number of steps per day obtained a negative association with cfPWV ( ß = -0.052) and VAI ( ß = -0.216), while sedentary time showed a positive association with cfPWV ( ß = 0.028) and VAI ( ß = 0.117). In the analysis by sex, the results showed similar values. The odds ratio (OR) of total physical activity of subjects classified as early vascular aging (EVA) with regarding those classified as healthy vascular aging (HVA) was 0.521 (95% confidence interval [CI] 0.317 to 0.856) for cfPWV, and 0.565 (95% CI 0.324 to 0.986) for VAI. In terms of the number of steps per day, the OR was 0.931 (95% CI 0.875 to 0.992) for cfPWV and 0.916 (95% CI 0.847 to 0.990) for VAI and for sedentary time the OR was 1.042 (95% CI 1.011 to 1.073) for cfPWV and 1.037 (95% CI 1.003 to 1.072) for VAI. The OR of subjects classified as vigorous physical activity was 0.196 (95% CI 0.041 to 0.941) using cfPWV and 0.161 (95% CI 0.032 to 0.820) using VAI. In the analysis by sex, the results showed an association in men when cfPWV was used and an association in women when VAI was used to define vascular aging. Conclusions: The results of this study indicate that the more time spent performing physical activity and the less sedentary time, the lower the arterial stiffness and the probability of developing early vascular aging. Clinical Trial Registration: The study was registered in ClinicalTrials.gov (number: NCT02623894).

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.

Effect of an intensive intervention on the increase of physical activity and the decrease of sedentary lifestyle in inactive postmenopausal.

BACKGROUND: During the transition to menopause, women experience different psychological, hormonal, and physical alterations that can affect their health. Physical activity is considered an important strategy in the prevention and control of such changes. AIM: To evaluate the short-term effect of an intensive intervention, based on a combined exercise programme using a Smartband, on the increase of physical activity and the decrease of sedentary lifestyle in postmenopausal and inactive women. DESIGN: Randomized clinical trial with two parallel groups. METHODS: In total, 100 postmenopausal and inactive women aged 45-70 years will be randomized to a control group or an intervention group. Both groups will be given a standardized advice about physical activity. The intervention group will carry out a supervised 12-week programme of aerobic and muscle strengthening exercise; moreover, the women in this group will receive a Smartband to assist them in the intervention. The main result will be the increase of physical activity and the decrease of sedentary lifestyle, measured with an accelerometer for 1 week. This programme will be conducted by a nurse and a physiotherapist of the health centre. The study was approved by the Drug Research Ethics Committee of the Salamanca Health Service on 15 February 2019. The project was funded by the Autonomous Government of Castile and Leon and by the Carlos III Health Institute. DISCUSSION: Physical activity is an important strategy to consider when addressing the changes caused by menopause, although the current evidence shows that further studies should be carried out with longer intervention periods and new technologies. IMPACT: This study will allow determining the effectiveness of the intensive intervention based on a combined programme of physical activity using a Smartband in postmenopausal and inactive women. TRIALS REGISTRATION: ClinicalTrials.gov with identifying code NCT03872258.

Prevalence of coronary atherosclerosis and reclassification of cardiovascular risk in Spanish population by coronary computed tomography angiography: EVA study.

BACKGROUND: A more complete assessment of coronary artery disease (CAD) can be performed by coronary computed tomography angiography (CCTA). The aim was to assess the prevalence, distribution and characteristics of coronary artery disease (CAD) and the reclassification of cardiovascular risk by CCTA in an asymptomatic Spanish population. DESIGN: We included, in a cross-sectional study, 501 random subjects from asymptomatic population, aged 35 and 75. Risk factors, target organ damage and cardiovascular risk were assessed. CCTA was offered to measure the coronary artery calcium score(CACS), segment involvement score(SIS) and segment stenosis score(SSS). The offer was accepted by 220 subjects (44%), with a mean age of 58 ± 14 years, 56% of them male. RESULTS: The mean CACS was 119.6 ± 381.7 (median (IQR) (0 (0-61.55))), with higher scores in males (191.9 ± 493.1) than females (26.1 ± 73.3; P < .01). CCTA revealed coronary atherosclerosis in 89 cases, 40% (CI95%:34%-46%) in global, 51% in male and 25% in female, of which 13 had obstructive lesions (5.9%). Mean SIS was 1.5 ± 2.5 and SSS 1.2 ± 3.1. When the CACS was included in the CAD risk scale, there was a reclassification of 24%, and when using the SIS percentile, it was 38%, with a 9% increase in risk in both cases. CONCLUSIONS: The prevalence of CAD in asymptomatic Spanish population was 40%, with greater proportion among males. The incorporation of CACS and SIS in the assessment of cardiovascular risk allows reclassifying subjects who are at low or moderate risk and thus identify those with high cardiovascular risk and also the other way.

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.

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.

Relationship between addictions and obesity, physical activity and vascular aging in young adults (EVA-Adic study): a research protocol of a cross-sectional study.

Background: Behavioral and substance addictions are prevalent health problems that, alongside obesity, are linked to reduced physical activity and increased sedentary time. Similarly, arterial stiffness and vascular aging are processes that begin gradually at an early age and are closely associated with morbidity and mortality from cardiovascular diseases. The main objective of this study is to analyze how addictions are related to obesity and body fat distribution, physical activity, sedentary time, arterial stiffness and vascular aging, as well as sleep quality, cognitive function and gender differences in young adults aged between 18 and 34 years. Methods: This cross-sectional descriptive observational study will analyze data from 500 subjects (250 men and 250 women) aged 18-34 without cardiovascular disease, selected by simple random sampling with replacement from the urban population of the city center of Salamanca (34,044 people aged 18-34, with 18,450 women and 15,594 men). Behavioral and substance addictions, as well as sleep quality and cognitive impairment will be assessed using questionnaires. The Pittisburg Sleep Quality Index (PSQI) will be used to measure sleep quality and the Ford questionnaire will be used to measure insomnia in response to stress. For obesity, weight, height, waist and hip circumference, body composition will be measured with the Inbody 230® impedance meter. For physical activity and sedentary time, we will use the Actigraph® accelerometer alongside the international physical activity questionnaire (IPAQ) and the Marshall questionnaire. The Sphygmocor System® will be used for pulse wave analysis and carotid-femoral pulse wave velocity (cfPWV), while the Vasera VS-2000® will measure cardio ankle vascular index (CAVI) and brachial-ankle pulse wave velocity (baPWV). Vascular aging will be calculated with the 10th and 90th percentiles of cfPWV or baPWV. Demographic, analytical variables will be collected, as will data to assess vascular, cardiac, renal, and brain injury. Discussion: Addictions are on the rise in today's society, affecting the mental health and well-being of those who suffer from them, generating important social problems such as job loss, family dysfunction, debt and social isolation. Together with obesity, they are prevalent health problems in young adults and are associated with lower physical activity and higher sedentary time. Meanwhile, arterial stiffness and vascular aging are processes that begin gradually at an early age and determine morbidity and mortality caused by cardiovascular diseases. The results of this project will allow us to understand the situation regarding behavioral and substance addictions in young adults. Better understanding of these addictions will in turn facilitate the development of more effective prevention strategies and intervention programs, which can then reduce the negative impact at both the individual and societal levels. Clinical trial registration: [ClinicalTrials.gov], identifier [NCT05819840].

Progression in central blood pressure and hemodynamic parameters and relationship with cardiovascular risk factors in a Spanish population. EVA follow-up study.

BACKGROUND: The progression of Central Blood Pressure (CBP) values and central hemodynamic parameters and its relationship with cardiovascular risk factors is quite unknown. We sought to investigate this association in a Spanish adult population without cardiovascular diseases. METHODS: Prospective observational research with a five-year follow-up. Randomly sampled 501 individuals (mean age 56±14 years, 50.3% women). After five years, 480 individuals had a follow-up. Measurements taken using the SphygmoCor® (AtCor Medical Pty Ltd., Head Office,West Ryde, Australia), following all the recommendations established in the "International task force"1, giving an estimate of central blood pressure relative to measured brachial blood pressure (type 1 device). RESULTS: Progressions during follow-up: central systolic blood pressure (cSBP): 4.16±13.71 mmHg; central diastolic blood pressure (cDBP): 2.45±11.37 mmHg; central pulse pressure (cPP): 1.72±12.43 mmHg; pulse pressure amplification (PPA): 2.85±12.20 mmHg; ejection duration (ED): 7.00±47.87 ms; subendocardial viability ratio (SEVR): -8.04±36.24%. In multiple regression analysis: cSBP positively associated with: BMI (ß=0.476); waist size (ß=0.159); number of cigarettes per day (ß=0.192). Inversely associated with peripheral systolic blood pressure (ß=-0.282). cDBP increase positively associated with number of cigarettes per day (ß=0.174). Inversely associated with peripheral diastolic blood pressure (ß=-0.292). cPP increase positively associated with BMI (ß=0.330). Inversely associated with peripheral pulse pressure (ß=-0.262). PPA increase positively associated with: BMI (ß=0.276); number of cigarettes per day (ß=0.281). ED progress inversely associated with basal plasma glucose (ß=-0.286). CONCLUSIONS: All measures increased except for SEVR. Progressions in CBP and PPA were positively associated with anthropometric parameters and number of cigarettes and CBP inversely associated with peripheral blood pressure, although this association was different according to sex.

Relationship between the Mediterranean Diet and Metabolic Syndrome and Each of the Components That Form It in Caucasian Subjects: A Cross-Sectional Trial.

The main objective of this work is to investigate the relationship between the Mediterranean diet (MD) and metabolic syndrome (MetS) and its components in Caucasian subjects between 35 and 74 years. The secondary objective is to analyze sex differences. METHODS: A cross-sectional trial. This study utilized data from the EVA, MARK, and EVIDENT studies, and a total of 3417 subjects with a mean age ± SD of 60.14 ± 9.14 years (57% men) were included. We followed the five criteria established in the National Cholesterol Education Program III to define MetS. The MD was assessed with the 14-item Mediterranean diet adherence screener (MEDAS) used in the PREDIMED study. Good adherence was considered when the MD value was higher than the median value. RESULTS: The mean ± SD value of the MEDAS questionnaire was 5.83 ± 2.04 (men 5.66 ± 2.06 and women 6.04 ± 1.99; p < 0.001). Adherence to the MD was observed by 38.6% (34.3% men and 40.3% women; p < 0.001). MetS was observed in 41.6% (39.0% men and 45.2% women; p < 0.001). In the multiple regression analysis, after adjusting for possible confounders, the mean MD value showed a negative association with the number of MetS components per subject (ß = -0.336), and with the different components of MetS: systolic blood pressure (ß = -0.011), diastolic blood pressure (ß = -0.029), glycemia (ß = -0.009), triglycerides (ß = -0.004), and waist circumference (ß = -0.026), except with the HDL-cholesterol value which showed a positive association (ß = 0.021); p < 0.001 in all cases. In the logistic regression analysis performed, we found that an increase in MD adherence was associated with a decrease in the probability of MetS (OR = 0.56) and its components: blood pressure levels ≥ 130/85 mmHg (OR = 0.63), fasting plasma glucose ≥ 100 mg/dL (OR = 0.62), triglyceride levels ≥ 150 mg/dL (OR = 0.65), waist circumference levels ≥ 88 cm in women and ≥102 cm in men (OR = 0.74), and increased high-density lipoprotein cholesterol < 40 mg/dL in men and <50 mg/dL in women (OR = 1.70); p < 0.001 in all cases. The results by sex were similar, both in multiple regression and logistic regression. CONCLUSIONS: The results found in our work indicate that the greater the adherence to the MD, the lower the probability of presenting MetS. This result is repeated in the study by sex. More studies are needed to clarify that these results can be extended to the rest of the Mediterranean countries, and to other countries outside the Mediterranean basin.

Comparative effect of antihypertensive drugs in improving arterial stiffness in adults with hypertension (RIGIPREV study). A network meta-analysis.

Aims: To synthesize and evaluate the available scientific evidence on the efficacy of antihypertensive drugs on arterial stiffness in patients with hypertension by using a network meta-analysis approach. Methods: A systematic search of the MEDLINE (via PubMed), Scopus, and Web of Science databases was conducted to identify experimental studies addressing the effect of different antihypertensive drugs on arterial stiffness parameters (pulse wave velocity [PWV] and augmentation index [AIx]) in adults with hypertension. Comparative evaluation of the effect of antihypertensive drugs was performed by conducting a standard pairwise meta-analysis and a network meta-analysis for direct and indirect comparisons between antihypertensive drugs and placebo/other antihypertensive drugs. Analyses were performed including studies of any duration and only studies longer than 6 months length. Results: Seventy-six studies were included in the main analysis and considering only studies longer than 6 months length, thiazide diuretics, ACEIs, ARBs, the ACEI/ARB combination, the ACEI/CCB combination, and the ARB/CCB combination showed a higher effect on reducing PWV, and ACEIs and ARBs on reducing AIx. Conclusion: Our research provides evidence that antihypertensive medications are an effective way to treat arterial stiffness in adults with hypertension. Based on our findings, patients with hypertension who have greater levels of arterial stiffness may benefit from using thiazide diuretics, ACEIs, ARBs, the ACEI/ARB combination, the ACEI/CCB combination, and the ARB/CCB combination. Systematic Review Registration: PROSPERO (CRD42021276360).

Increase in Vascular Function Parameters According to Lifestyles in a Spanish Population without Previous Cardiovascular Disease-EVA Follow-Up Study.

The aim of this longitudinal descriptive observational study was to analyze the influence of different lifestyles on arterial stiffness (AS) throughout five years of follow-up and to describe the differences by sex in a Spanish adult population without cardiovascular disease at the start of the study. A random stratified sampling by age and sex was used to obtain 501 subjects included in the initial assessment. No cardiovascular disease was allowed in the subjects. The average age was 55.9 years, and 50.3% were women. A total of 480 subjects were analyzed again five years later. Alcohol and tobacco consumption were collected with standardized questionnaires. Adherence to the Mediterranean diet was assessed with the Mediterranean diet adherence screener (MEDAS) questionnaire. Physical activity was assessed with the short version of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) and sedentary time was assessed with the Marshall Sitting Questionnaire (MSQ). AS was assessed by measuring carotid-femoral pulse wave velocity (cfPWV) and central augmentation index (CAIx) with SphygmoCor System®, and ankle pulse wave velocity (baPWV) and cardio ankle vascular index (CAVI) with Vasera VS-1500®. Increases in vascular function measures per year of follow-up were: cfPWV = 0.228 ± 0.360 m/s, baPWV = 0.186 ± 0.308 m/s, CAVI = 0.041 ± 0.181 m/s, and CAIx = 0.387 ± 2.664 m/s. In multiple regression analysis, positive association was shown between an increase in baPWV and tobacco index (ß = 0.007) and alcohol consumption (ß = 0.005). Negative association was shown between CAVI and Mediterranean diet score (ß = -0.051). In multinomial logistic regression analysis, the OR of tobacco index of subjects with a cfPWV increase >P75 was OR = 1.025 and of subjects classified between P25 and P75 was OR = 1.026 regarding subjects classified with an increase P75 was OR = 1.006 regarding subjects classified with an increase P75, and an OR = 0.841 was found of subjects classified between P25-75 regarding subjects classified with an increase

Effect of a lifestyle-integrated functional exercise (LiFE) group intervention (sLiFE) to falls prevention in non-institutionalized older adults. Protocol of a randomised clinical trial.

Introduction: Personalized programs of integrated strength and balance activities have been shown their effectiveness in falls reduction in the older adults. Objective: To measure whether a group intervention with the strength and balance principles of the sLiFE program is more effective than standard health advice in reducing the incidence of falls. Methods: The study will comprise 650 participants with more than 65 years who live at home, observing established inclusion and exclusion criteria. Participants will be randomly assigned in two groups: group intervention (n = 325) and standard health advice (n = 325). The intervention group will follow the balance and strength activities described in the LiFE program manual. The group intervention will be carried out in groups of 12-14 and will consist of seven one-hour sessions over 12 weeks in health centres. Incidence of falls and quality of life will be assessed as primary outcome variables. Fear of falling and exercise adherence will be analysed as secondary outcome variables. Discussion: Physical activity has been put forward as an effective treatment technique for these patients; however, long-term adherence to these programs remains a challenge. Group interventions could reduce dropout rates. Conclusion: Falls represent a major health problem globally due to the disability they cause in older people. Prevention would help reduce not only their incidence but also the health costs derived from their treatment. Group intervention helps clinicians to save resources and time, being able to attend more people with the same quality of care. Clinical trial registration: https://clinicaltrials.gov/study/NCT05912088?distance=50&term=NCT05912088&rank=1, identifier NCT05912088.

Relationship between the structure, function and endothelial damage, and vascular ageing and the biopsychological situation in adults diagnosed with persistent COVID (BioICOPER study). A research protocol of a cross-sectional study.

Background: SARS-CoV-2 infection affects the vascular endothelium, which mediates the inflammatory and thrombotic cascade. Moreover, alterations in the endothelium are related to arterial stiffness, which has been established as a marker of cardiovascular disease. The objective of this study is to analyse how the structure, vascular function, vascular ageing and endothelial damage are related to the biopsychological situation in adults diagnosed with persistent COVID and the differences by gender. Methods: This cross-sectional, descriptive, observational study will be carried out in the Primary Care Research Unit of Salamanca (APISAL) and in the BioSepsis laboratory of the University of Salamanca. The sample will be selected from the persistent COVID monographic office at the Internal Medicine Service of the University Hospital of Salamanca, and from the population of subjects diagnosed with persistent COVID in the clinical history of Primary Care. Through consecutive sampling, the study will include 300 individuals diagnosed with persistent COVID who meet the diagnosis criteria established by the WHO, after they sign the informed consent. Endothelial damage biomarkers will be measured using ELLA-SimplePlexTM technology (Biotechne). Their vascular structure and function will be analysed by measuring the carotid intima-media thickness (Sonosite Micromax); the pulse wave and carotid-femoral pulse wave velocity (cfPWV) will be recorded with Sphygmocor System®. Cardio Ankle Vascular Index (CAVI), brachial-ankle pulse wave velocity (baPWV) and ankle-brachial index will be analysed with Vasera VS-2000®. The integral assessment of the subjects with persistent COVID will be conducted with different scales that evaluate fatigue, sleep, dyspnea, quality of life, attention, nutrition state, and fragility. We will also evaluate their lifestyles (diet, physical activity, smoking habits and alcohol consumption), psychological factors, and cognitive deterioration, which will be gathered through validated questionnaires; moreover, physical activity will be objectively measured using a pedometer for 7 days. Body composition will be measured through impedance using an Inbody 230. Vascular ageing will be calculated with 10 and 90 percentiles of cfPWV and baPWV. Furthermore, we will analyse the presence of vascular injury in the retina, heart, kidneys and brain, as well as cardiovascular risk. Demographic and analytical variables will also be gathered. Discussion: Arterial stiffness reflects the mechanic and functional properties of the arterial wall, showing the changes in arterial pressure, blood flow, and vascular diameter that occur with each heartbeat. SARS-CoV-2 affects the endothelial cells that are infected with this virus, increasing the production of pro-inflammatory cytokines and pro-thrombotic factors, which can cause early vascular ageing and an increase of arterial stiffness. Persistent COVID is a complex heterogeneous disorder that affects the lives of millions of people worldwide. The identifications of potential risk factors to better understand who is at risk of developing persistent COVID is important, since this would enable early and appropriate clinical support. It is unknown whether vascular alterations caused by COVID-19 resolve after acute infection or remain over time, favouring the increase of arterial stiffness and early vascular ageing. Therefore, it is necessary to propose studies that analyse the evolution of persistent COVID in this group of patients, as well as the possible variables that influence it. Clinical Trial registration: ClinicalTrials.gov, identifier NCT05819840.

Lifestyles, arterial aging, and its relationship with the intestinal and oral microbiota (MIVAS III study): a research protocol for a cross-sectional multicenter study.

Background: The microbiota is increasingly recognized as a significant factor in the pathophysiology of many diseases, including cardiometabolic diseases, with lifestyles probably exerting the greatest influence on the composition of the human microbiome. The main objectives of the study are to analyze the association of lifestyles (diet, physical activity, tobacco, and alcohol) with the gut and oral microbiota, arterial aging, and cognitive function in subjects without cardiovascular disease in the Iberian Peninsula. In addition, the study will examine the mediating role of the microbiome in mediating the association between lifestyles and arterial aging as well as cognitive function. Methods and analysis: MIVAS III is a multicenter cross-sectional study that will take place in the Iberian Peninsula. One thousand subjects aged between 45 and 74 years without cardiovascular disease will be selected. The main variables are demographic information, anthropometric measurements, and habits (tobacco and alcohol). Dietary patterns will be assessed using a frequency consumption questionnaire (FFQ) and the Mediterranean diet adherence questionnaire. Physical activity levels will be evaluated using the International Physical Activity Questionnaire (IPAQ), Marshall Questionnaire, and an Accelerometer (Actigraph). Body composition will be measured using the Inbody 230 impedance meter. Arterial aging will be assessed through various means, including measuring medium intimate carotid thickness using the Sonosite Micromax, conducting analysis with pulse wave velocity (PWA), and measuring pulse wave velocity (cf-PWV) using the Sphygmocor System. Additional cardiovascular indicators such as Cardio Ankle Vascular Index (CAVI), ba-PWV, and ankle-brachial index (Vasera VS-2000®) will also be examined. The study will analyze the intestinal microbiota using the OMNIgene GUT kit (OMR-200) and profile the microbiome through massive sequencing of the 16S rRNA gene. Linear discriminant analysis (LDA), effect size (LEfSe), and compositional analysis, such as ANCOM-BC, will be used to identify differentially abundant taxa between groups. After rarefying the samples, further analyses will be conducted using MicrobiomeAnalyst and R v.4.2.1 software. These analyses will include various aspects, such as assessing α and ß diversity, conducting abundance profiling, and performing clustering analysis. Discussion: Lifestyle acts as a modifier of microbiota composition. However, there are no conclusive results demonstrating the mediating effect of the microbiota in the relationship between lifestyles and cardiovascular diseases. Understanding this relationship may facilitate the implementation of strategies for improving population health by modifying the gut and oral microbiota. Trial registration: clinicaltrials.gov/ct2/show/NCT04924907, ClinicalTrials.gov, identifier: NCT04924907. Registered on 21 April 2021.

The association of egg consumption with blood pressure levels and glycated hemoglobin in Spanish adults according to body mass index.

The objective of this study was to evaluate the association of egg consumption with blood pressure (BP) and glycated hemoglobin (HbA1c). In addition, it was assessed whether this association changes according to body weight status. This cross-sectional study is based on multicenter data from Spanish adult participants in the EVIDENT II trial. Egg consumption was assessed with a Food Frequency Questionnaire, and data on BP and HbA1c were collected using standardized procedures. Linear regression and ANCOVA models adjusted for the main confounders were performed. The analyses were stratified by body weight status. A total of 668 participants were analyzed (mean age 52.4 ± 11.8 years, 62.3% women). Compared with lower consumption, higher egg consumption was associated with lower systolic (ß = - 6.15 ± 1.74; p-for-trend = 0.017), diastolic (ß = - 4.41 ± 1.03; p-for-trend = 0.002), and mean arterial pressure (ß = - 4.99 ± 1.17; p-for-trend = 0.003) and with lower HbA1c (ß = - 0.19 ± 0.06; p-for-trend = 0.019) levels. These associations lost statistical significance in the adjusted analyses. The results did not vary by body weight status. In conclusion, consumption of up to 1 egg per day is not associated with BP or HbA1c, even in overweight or obese individuals. Our findings suggested that this frequency of egg consumption is safe as part of a healthy diet and lifestyle for cardiometabolic risk.

Egg Consumption and Blood Lipid Parameters According to the Presence of Chronic Metabolic Disorders: The EVIDENT II Study.

CONTEXT: Egg consumption is one of the main dietary sources of cholesterol, but whether individuals who eat more eggs have a worse blood lipid profile remains controversial. OBJECTIVE: We examined the relationship between egg consumption and lipid parameters and explored whether this relationship changes according to the presence of chronic metabolic disorders. METHODS: A multicenter cross-sectional study was conducted with adult participants in the EVIDENT II trial. Adjusted linear regression models were stratified by the main chronic metabolic disorders. RESULTS: Among the 728 participants (61.9% women, mean age 52.1 ± 11.9 years), the mean egg consumption was equivalent to 5 to 6 eggs per week for a 70-kg individual. In the fully adjusted analysis, no association was found of egg consumption with total and high-density lipoprotein cholesterol (HDL-c), and triglyceride levels. Furthermore, compared with the first quartile of consumption, the fourth quartile was associated with lower low-density lipoprotein cholesterol (LDL-c) levels (coefficient -7.01; 95% CI -13.39, -0.62) and a lower LDL-c/HDL-c ratio (coefficient -0.24, 95% CI -0.41, -0.06). In the analyses stratified by chronic metabolic diseases, higher egg consumption was not associated with lipid profile in those with obesity, hypertension, type 2 diabetes, dyslipidemia, or treated with hypolipidemic drugs, and was associated with a better lipid profile in participants without these conditions. CONCLUSION: Higher egg consumption was not associated with blood lipids in individuals with chronic metabolic disorders. In individuals without such conditions, the lipid profile was better among those who consumed more eggs. Our findings support current guidelines recommending eggs as part of a healthy diet.