Cohort Profile: Design and methods of the PREDIMED-Plus randomized trial

Martínez‐González, Miguel Ángel; Buil‐Cosiales, Pilar; Corella, Dolores; Bulló, Mònica; Fitó, Montserrat; Vioque, Jesús; Romaguera, Dora; Martínéz, J. Alfredo; Wärnberǵ, Julia; López‐Miranda, José; Estruch, Ramón; Bueno‐Cavanillas, Aurora; Arós, Fernando; Tur, Josep A.; Tinahones, Francisco J.; Serra‐Majem, Lluís; Martín, Vicente; Lapetra, José; Vázquez, Clotilde; Pintó, Xavier; Vidal, Josep; Daimiel, Lidia; Delgado-Rodrı́guez, Miguel; Matía, Pilar; Ros, Emilio; Fernández‐Aranda, Fernando; Botella, Cristina; Portillo, Marı́a P.; Lamuela‐Raventós, Rosa María; Marcos, Ascensión; Sáez, Guillermo T.; Gómez‐Gracia, Enrique; Ruiz‐Canela, Miguel; Álvarez‐Álvarez, Ismael; Díez‐Espino, Javier; Sorlí, José V.; Basora, Josep; Castañer, Olga; Schröder, Helmut; Muñoz, Miguel Ángel; Zulet, M. Ángeles; García‐Rios, Antonio; Salas‐Salvadó, Jordi; Investigators, PREDIMED-Plus

doi:10.1093/ije/dyy225

Cited by 192 publications

(196 citation statements)

References 72 publications

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“…We analyzed participants in the PREDIMED Plus-Valencia study [105]. The University of Valencia (located in the eastern Mediterranean coast), is one of the field centers of the multi-center PREDIMED Plus study, an ongoing primary prevention trial conducted in Spain [106]. A detailed description of the trial is available at http://predimedplus.com/.…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…In Spain, the adherence to the Mediterranean diet pattern [99] is still relatively high in older subjects, but is decreasing in young people [100,101]. Although some studies specifically carried out in the Spanish Mediterranean population, have analyzed the association between several FADS and ELOVL candidate gene polymorphisms and PUFA concentrations [102][103][104][105][106], no study has investigated such associations at the GWAS level.…”

Section: Introductionmentioning

confidence: 99%

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Genome-Wide Association Study for Serum Omega-3 and Omega-6 Polyunsaturated Fatty Acids: Exploratory Analysis of the Sex-Specific Effects and Dietary Modulation in Mediterranean Subjects with Metabolic Syndrome

et al. 2020

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Many early studies presented beneficial effects of polyunsaturated fatty acids (PUFA) on cardiovascular risk factors and disease. However, results from recent meta-analyses indicate that this effect would be very low or nil. One of the factors that may contribute to the inconsistency of the results is that, in most studies, genetic factors have not been taken into consideration. It is known that fatty acid desaturase (FADS) gene cluster in chromosome 11 is a very important determinant of plasma PUFA, and that the prevalence of the single nucleotide polymorphisms (SNPs) varies greatly between populations and may constitute a bias in meta-analyses. Previous genome-wide association studies (GWAS) have been carried out in other populations and none of them have investigated sex and Mediterranean dietary pattern interactions at the genome-wide level. Our aims were to undertake a GWAS to discover the genes most associated with serum PUFA concentrations (omega-3, omega-6, and some fatty acids) in a scarcely studied Mediterranean population with metabolic syndrome, and to explore sex and adherence to Mediterranean diet (MedDiet) interactions at the genome-wide level. Serum PUFA were determined by NMR spectroscopy. We found strong robust associations between various SNPs in the FADS cluster and omega-3 concentrations (top-ranked in the adjusted model: FADS1-rs174547, p = 3.34 × 10−14; FADS1-rs174550, p = 5.35 × 10−14; FADS2-rs1535, p = 5.85 × 10−14; FADS1-rs174546, p = 6.72 × 10−14; FADS2-rs174546, p = 9.75 × 10−14; FADS2-rs174576, p = 1.17 × 10−13; FADS2-rs174577, p = 1.12 × 10−12, among others). We also detected a genome-wide significant association with other genes in chromosome 11: MYRF (myelin regulatory factor)-rs174535, p = 1.49 × 10−12; TMEM258 (transmembrane protein 258)-rs102275, p = 2.43 × 10−12; FEN1 (flap structure-specific endonuclease 1)-rs174538, p = 1.96 × 10−11). Similar genome-wide statistically significant results were found for docosahexaenoic fatty acid (DHA). However, no such associations were detected for omega-6 PUFAs or linoleic acid (LA). For total PUFA, we observed a consistent gene*sex interaction with the DNTTIP2 (deoxynucleotidyl transferase terminal interacting protein 2)-rs3747965 p = 1.36 × 10−8. For adherence to MedDiet, we obtained a relevant interaction with the ME1 (malic enzyme 1) gene (a gene strongly regulated by fat) in determining serum omega-3. The top-ranked SNP for this interaction was ME1-rs3798890 (p = 2.15 × 10−7). In the regional-wide association study, specifically focused on the FADS1/FASD2/FADS3 and ELOVL (fatty acid elongase) 2/ELOVL 5 regions, we detected several statistically significant associations at p < 0.05. In conclusion, our results confirm a robust role of the FADS cluster on serum PUFA in this population, but the associations vary depending on the PUFA. Moreover, the detection of some sex and diet interactions underlines the need for these associations/interactions to be studied in all specific populations so as to better understand the complex metabolism of PUFA.

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Section: Study Design and Participantsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Genome-Wide Association Study for Serum Omega-3 and Omega-6 Polyunsaturated Fatty Acids: Exploratory Analysis of the Sex-Specific Effects and Dietary Modulation in Mediterranean Subjects with Metabolic Syndrome

et al. 2020

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“…21 Information about exclusion criteria has been previously published. 20 Most of participants (97.5%) were of Caucasian origin. All participants provided written informed consent, and the study protocol and procedures were approved according to the ethical standards of the Declaration of Helsinki by all the participating institutions.…”

Section: Study Subjectsmentioning

confidence: 99%

“…The eligible participants were community‐dwelling adults (aged 65.2 ± 4.9 years) with overweight/obesity [body mass index (BMI) = 32.5 ± 3.3 kg/m 2 ], who met at least three components of the metabolic syndrome according to the updated harmonized criteria of the International Diabetes Federation and the American Heart Association and National Heart, Lung and Blood Institute . Information about exclusion criteria has been previously published . Most of participants (97.5%) were of Caucasian origin.…”

Section: Introductionmentioning

confidence: 99%

Association of lifestyle factors and inflammation with sarcopenic obesity: data from the PREDIMED‐Plus trial

Abete

Konieczna

Zulet

et al. 2019

J cachexia sarcopenia muscle

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Background Sarcopenia is a progressive age‐related skeletal muscle disorder associated with increased likelihood of adverse outcomes. Muscle wasting is often accompanied by an increase in body fat, leading to ‘sarcopenic obesity’. The aim of the present study was to analyse the association of lifestyle variables such as diet, dietary components, physical activity (PA), body composition, and inflammatory markers, with the risk of sarcopenic obesity. Methods A cross‐sectional analysis based on baseline data from the PREDIMED‐Plus study was performed. A total of 1535 participants (48% women) with overweight/obesity (body mass index: 32.5 ± 3.3 kg/m2; age: 65.2 ± 4.9 years old) and metabolic syndrome were categorized according to sex‐specific tertiles (T) of the sarcopenic index (SI) as assessed by dual‐energy X‐ray absorptiometry scanning. Anthropometrical measurements, biochemical markers, dietary intake, and PA information were collected. Linear regression analyses were carried out to evaluate the association between variables. Results Subjects in the first SI tertile were older, less physically active, showed higher frequency of abdominal obesity and diabetes, and consumed higher saturated fat and less vitamin C than subjects from the other two tertiles (all P < 0.05). Multiple adjusted linear regression models evidenced significant positive associations across tertiles of SI with adherence to the Mediterranean dietary score (P‐trend < 0.05), PA (P‐trend < 0.0001), and the 30 s chair stand test (P‐trend < 0.0001), whereas significant negative associations were found with an inadequate vitamin C consumption (P‐trend < 0.05), visceral fat and leucocyte count (all P‐trend < 0.0001), and some white cell subtypes (neutrophils and monocytes), neutrophil‐to‐lymphocyte ratio, and platelet count (all P‐trend < 0.05). When models were additionally adjusted by potential mediators (inflammatory markers, diabetes, and waist circumference), no relevant changes were observed, only dietary variables lost significance. Conclusions Diet and PA are important regulatory mediators of systemic inflammation, which is directly involved in the sarcopenic process. A healthy dietary pattern combined with exercise is a promising strategy to limit age‐related sarcopenia.

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“…This research was a cross-sectional analysis of baseline data within the frame of the Prevención con Dieta Mediterránea (PREDIMED-Plus) trial, an ongoing six-year multicentre, parallel-group, randomised trial conducted in Spain, in order to evaluate the effect of a weight loss intervention programme based on an energy-restricted traditional MD, with physical activity promotion and behavioural support on cardiovascular disease morbimortality, compared with the usual care advice, consisting exclusively of an energy unrestricted traditional MD (control group). Details of the PREDIMED-Plus study protocol are fully described [13] and available at http://predimedplus.com/. The trial was registered in 2014 at the International Standard Randomized Controlled Trial (ISRCT; http://www.isrctn.com/ISRCTN89898870) with number 89898870.…”

Section: Methodsmentioning

confidence: 99%

Leisure-Time Physical Activity, Sedentary Behaviour and Diet Quality are Associated with Metabolic Syndrome Severity: The PREDIMED-Plus Study

Gallardo-Alfaro¹,

Bibiloni²,

Mascaró³

et al. 2020

Nutrients

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Healthy lifestyle factors, such as physical activity (PA) and Mediterranean diet (MD), decrease the likelihood of developing metabolic syndrome (MetS). The aim of this study was to report main lifestyle components and related factors according to the MetS severity. Cross-sectional analysis was done of baseline lifestyle factors from 5739 participants with overweight/obesity and MetS features (aged 55-75 years) included in the PREDIMED-PLUS primary cardiovascular prevention randomized trial. Participants were categorized in tertiles according to a validated MetS severity score (MetSSS). Anthropometrics, visceral adiposity index, dietary nutrient intake, biochemical marker levels, as well as a Dietary Inflammatory Index and depression symptoms (Beck Depression Inventory-II) were measured. Diet quality was assessed using a 17-item energy-restricted MD questionnaire. Duration and intensity of PA was self-reported using the Minnesota-REGICOR Short Physical Activity Questionnaire. Sedentary behaviours were measured using the Spanish version of the Nurses' Health Study questionnaire. The 30 s chair stand test was also assessed. Participants with highest MetSSS showed higher values of cardiovascular risk factors (except for total cholesterol and LDL cholesterol), depression risk, sedentary and TV viewing time, and lower moderate and vigorous Nutrients 2020, 12, 1013 3 of 20 leisure-time physical activity (LTPA). Highest MetSSS participants tended to a pro-inflammatory dietary pattern and tended to lower MD adherence. In addition, they showed lower carbohydrate and nut intake and higher intake of protein, saturated and trans fatty acids, cholesterol, iodine, sodium, red and processed meat products, other oils different from olive oil and spirit alcoholic drinks. The highest MetS severity score was associated with lower moderate and vigorous LTPA and higher sedentary time and depression risk, as they tended to a pro-inflammatory dietary pattern and lower MD adherence.

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Cohort Profile: Design and methods of the PREDIMED-Plus randomized trial

Cited by 192 publications

References 72 publications

Genome-Wide Association Study for Serum Omega-3 and Omega-6 Polyunsaturated Fatty Acids: Exploratory Analysis of the Sex-Specific Effects and Dietary Modulation in Mediterranean Subjects with Metabolic Syndrome

Genome-Wide Association Study for Serum Omega-3 and Omega-6 Polyunsaturated Fatty Acids: Exploratory Analysis of the Sex-Specific Effects and Dietary Modulation in Mediterranean Subjects with Metabolic Syndrome

Association of lifestyle factors and inflammation with sarcopenic obesity: data from the PREDIMED‐Plus trial

Leisure-Time Physical Activity, Sedentary Behaviour and Diet Quality are Associated with Metabolic Syndrome Severity: The PREDIMED-Plus Study

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