IIS-FJD - Instituto de Investigación Sanitaria Fundación Jiménez Díaz (Madrid)

Permanent URI for this collectionhttps://hdl.handle.net/20.500.12105/16977

El Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (IIS-FJD, UAM) es una entidad con una prolongada trayectoria de compromiso con la investigación y la docencia, además de su actividad clínica y asistencial. Su objetivo es impulsar, promover y fomentar la investigación de excelencia, el conocimiento científico y tecnológico, la docencia y la formación en el Hospital, y facilitar que los avances en la investigación y la innovación se trasladen de la manera más eficiente posible a la práctica asistencial. Se constituye como una estructura funcional orientada a la investigación biomédica básica, clínica, epidemiológica y en servicios de salud. Acreditado por el Instituto de Salud Carlos III como Instituto de Investigación Sanitaria en 2010, y renovando esta acreditación cada 5 años, forma parte así del total de 34 Institutos de Investigación Sanitaria acreditados existentes en la actualidad.

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Newer generations of multi-target CAR and STAb-T immunotherapeutics: NEXT CART Consortium as a cooperative effort to overcome current limitations
(Frontiers Media, 2024) Martín-Antonio, Beatriz; Blanco, Belén; González-Murillo, África; Hidalgo, Laura; Minguillón, Jordi; Pérez-Chacón, Gema; Next Generation CART MAD Consortium; Rodriguez-Milla, Miguel A; García-Rodriguez, Patricia; Somovilla-Crespo, Beatriz; Garcia-Castro, Javier; Comunidad de Madrid (España); Instituto de Salud Carlos III
Adoptive T cellular immunotherapies have emerged as relevant approaches for treating cancer patients who have relapsed or become refractory (R/R) to traditional cancer treatments. Chimeric antigen receptor (CAR) T-cell therapy has improved survival in various hematological malignancies. However, significant limitations still impede the widespread adoption of these therapies in most cancers. To advance in this field, six research groups have created the "NEXT Generation CART MAD Consortium" (NEXT CART) in Madrid's Community, which aims to develop novel cell-based immunotherapies for R/R and poor prognosis cancers. At NEXT CART, various basic and translational research groups and hospitals in Madrid concur to share and synergize their basic expertise in immunotherapy, gene therapy, and immunological synapse, and clinical expertise in pediatric and adult oncology. NEXT CART goal is to develop new cell engineering approaches and treatments for R/R adult and pediatric neoplasms to evaluate in multicenter clinical trials. Here, we discuss the current limitations of T cell-based therapies and introduce our perspective on future developments. Advancement opportunities include developing allogeneic products, optimizing CAR signaling domains, combining cellular immunotherapies, multi-targeting strategies, and improving tumor-infiltrating lymphocytes (TILs)/T cell receptor (TCR) therapy. Furthermore, basic studies aim to identify novel tumor targets, tumor molecules in the tumor microenvironment that impact CAR efficacy, and strategies to enhance the efficiency of the immunological synapse between immune and tumor cells. Our perspective of current cellular immunotherapy underscores the potential of these treatments while acknowledging the existing hurdles that demand innovative solutions to develop their potential for cancer treatment fully.
Global Dynamics of Gastrointestinal Colonisations and Antimicrobial Resistance: Insights from International Travellers to Low- and Middle-Income Countries
(Multidisciplinary Digital Publishing Institute (MDPI), 2024-08-17) Seijas-Pereda, Laura; Carmena, David; Rescalvo-Casas, Carlos; Hernando-Gozalo, Marcos; Prieto-Pérez, Laura; Cuadros-González, Juan; Pérez-Tanoira, Ramón
Gastrointestinal microorganism resistance and dissemination are increasing, partly due to international travel. This study investigated gastrointestinal colonisations and the acquisition of antimicrobial resistance (AMR) genes among international travellers moving between Spain and low- and middle-income countries (Peru and Ethiopia). We analysed 102 stool samples from 51 volunteers collected before and after travel, revealing significantly higher rates of colonisation by both bacteria and protists upon return. Diarrhoeagenic strains of were the most notable microorganism detected using RT-PCR with the Seegene Allplex™ Gastrointestinal Panel Assays. A striking prevalence of β-lactamase resistance genes, particularly the TEM gene, was observed both before and after travel. No significant differences in AMR genes were found between the different locations. These findings highlight the need for rigorous surveillance and preventive strategies, as travel does not significantly impact AMR gene acquisition but does affect microbial colonisations. This study provides valuable insights into the intersection of gastrointestinal microorganism acquisition and AMR in international travellers, underscoring the need for targeted interventions and increased awareness.
Prevalence and factors linked to renal involvement in prediabetes patients across Europe in the ePREDICE trial
(Nature Publishing Group, 2024-12-05) Más-Fontao, Sebastián; Civantos, Esther; Boukichou-Abdelkader, Nisa; Moreno, Juan A; Tuomilehto, Jaakko; Gabriel-Sanchez, Rafael; Egido, Jesús; Unión Europea. Comisión Europea. 7 Programa Marco; Instituto de Salud Carlos III; Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF); Centro de Investigación Biomédica en Red - CIBERDEM (Diabetes y Enfermedades Metabólicas asociadas); Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz; Merck KGaA; Boehringer Ingelheim Fonds
This sub-analysis of the ePREDICE trial, investigated the prevalence and determinants of renal complications, specifically glomerular hyperfiltration, albuminuria, and reduced kidney function, in individuals with prediabetes (PD). The cohort consisted of 967 participants from diverse backgrounds across seven countries. The kidney function was evaluated using the MDRD-4 equation, and the influence of various clinical and demographic factors on renal involvement was assessed by multivariable regression models. Additionally, insulinogenic and disposition indices were examined. Overall, the prevalence of renal abnormalities in this PD cohort was 9.2% (n = 89). Key findings included the detection of hyperfiltration in 20 (2%) individuals, albuminuria in 45 (4.7%), and CKD stage G3a in 29 (3%). Hyperfiltration was inversely correlated with age and height, while albuminuria showed a significant direct association with the disposition index (DI). Age and waist circumference were significantly and directly associated with estimated glomerular filtration rate (eGFR). The ePREDICE study highlights critical factors that affect renal involvement in PD individuals, revealing complex interactions among various parameters. These findings further emphasize the necessity for the search of early kidney abnormalities in people with PD especially in those in older age groups and with a large waist circumference.
Novel risk loci for COVID-19 hospitalization among admixed American populations
(eLife Sciences Publications, 2024-10-03) Diz-de Almeida, Silvia; Cruz, Raquel; Luchessi, Andre D; Lorenzo-Salazar, José M; López de Heredia, Miguel; Quintela, Inés; González-Montelongo, Rafaela; Nogueira Silbiger, Vivian; Porras, Marta Sevilla; Tenorio Castaño, Jair Antonio; Nevado, Julián; Aguado, José María; Aguilar, Carlos; Aguilera-Albesa, Sergio; Almadana, Virginia; Almoguera, Berta; Alvarez, Nuria; Andreu-Bernabeu, Álvaro; Arana-Arri, Eunate; Arango, Celso; Arranz, María J; Artiga, Maria-Jesus; Baptista-Rosas, Raúl C; Barreda-Sánchez, María; Belhassen-García, Moncef; Bezerra, Joao F; Bezerra, Marcos A C; Boix-Palop, Lucía; Brion, María; Brugada, Ramón; Bustos, Matilde; Calderón, Enrique J; Carbonell, Cristina; Castano, Luis; Castelao, Jose E; Conde-Vicente, Rosa; Cordero-Lorenzana, M Lourdes; Cortes-Sanchez, Jose L; Corton, Marta; Darnaude, M Teresa; De Martino-Rodríguez, Alba; Del Campo-Pérez, Victor; Diaz de Bustamante, Aranzazu; Domínguez-Garrido, Elena; Eirós, Rocío; Fariñas, María Carmen; Fernandez-Nestosa, María J; Fernández-Robelo, Uxía; Fernandez-Rodriguez, Amanda; Fernández-Villa, Tania; Gago-Dominguez, Manuela; Gil-Fournier, Belén; Gómez-Arrue, Javier; González Álvarez, Beatriz; González Bernaldo de Quirós, Fernan; González-Neira, Anna; González-Peñas, Javier; Gutiérrez-Bautista, Juan F; Herrero, María José; Herrero-Gonzalez, Antonio; Jimenez-Sousa, Maria Angeles; Lattig, María Claudia; Liger Borja, Anabel; Lopez-Rodriguez, Rosario; Mancebo, Esther; Martín-López, Caridad; Martín, Vicente; Martinez-Nieto, Oscar; Martinez-Lopez, Iciar; Martinez-Resendez, Michel F; Martinez-Perez, Angel; Mazzeu, Juliana F; Merayo Macías, Eleuterio; Minguez, Pablo; Moreno Cuerda, Victor; Oliveira, Silviene F; Ortega-Paino, Eva; Pompa-Mera, Ericka N; Parellada, Mara; Paz-Artal, Estela; Santos, Ney PC; Pérez-Matute, Patricia; Perez, Patricia; Pérez-Tomás, M Elena; Perucho, Teresa; Pinsach-Abuin, Mel·lina; Pita, Guillermo; Porras-Hurtado, Gloria L; Pujol, Aurora; Ramiro León, Soraya; Resino, Salvador; Fernandes, Marianne R; Rodríguez-Ruiz, Emilio; Rodríguez-Artalejo, Fernando; Rodriguez-Garcia, José A; Ruiz-Cabello, Francisco; Ruiz-Hornillos, Javier; Ryan, Pablo; Soria, José Manuel; Souto, Juan Carlos; Tamayo, Eduardo; Tamayo-Velasco, Álvaro; Taracido-Fernandez, Juan Carlos; Teper, Alejandro; Torres-Tobar, Lilian; Urioste, Miguel; Valencia-Ramos, Juan; Yáñez, Zuleima; Zarate, Ruth; de Rojas, Itziar; Ruiz, Agustín; Sánchez, Pascual; Real, Luis Miguel; SCOURGE Cohort Group; Guillén-Navarro, Encarna; Ayuso, Carmen; Parra, Esteban; Riancho, José A; Rojas-Martinez, Augusto; Flores, Carlos; Instituto de Salud Carlos III; Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF); Banco Santander; Fundación La Caixa; Agencia Estatal de Investigación (España); Gobierno de Canarias (España); Fundación Canaria de Investigación Sanitaria; Xunta de Galicia (España); Fundación Amancio Ortega; Estrella de Levante; Colabora Mujer
The genetic basis of severe COVID-19 has been thoroughly studied, and many genetic risk factors shared between populations have been identified. However, reduced sample sizes from non-European groups have limited the discovery of population-specific common risk loci. In this second study nested in the SCOURGE consortium, we conducted a genome-wide association study (GWAS) for COVID-19 hospitalization in admixed Americans, comprising a total of 4702 hospitalized cases recruited by SCOURGE and seven other participating studies in the COVID-19 Host Genetic Initiative. We identified four genome-wide significant associations, two of which constitute novel loci and were first discovered in Latin American populations ( and ). A trans-ethnic meta-analysis revealed another novel cross-population risk locus in . Finally, we assessed the performance of a cross-ancestry polygenic risk score in the SCOURGE admixed American cohort. This study constitutes the largest GWAS for COVID-19 hospitalization in admixed Latin Americans conducted to date. This allowed to reveal novel risk loci and emphasize the need of considering the diversity of populations in genomic research.
PIM1 is a potential therapeutic target for the leukemogenic effects mediated by JAK/STAT pathway mutations in T-ALL/LBL
(Nature Publishing Group, 2024-07-20) Lahera, Antonio; Vela-Martín, Laura; Fernandez-Navarro, Pablo L; Llamas, Pilar; López-Lorenzo, José L; Cornago, Javier; Santos, Javier; Fernández-Piqueras, José; Villa-Morales, María; Ministerio de Economía y Competitividad (España); Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF); Ministerio de Ciencia, Innovación y Universidades (España); Fundación Ramón Areces; Comunidad de Madrid (España); Asociación Española Contra el Cáncer; Fundación Banco Santander; Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Precursor T-cell neoplasms (T-ALL/LBL) are aggressive hematological malignancies that arise from the malignant transformation of immature thymocytes. Despite the JAK/STAT pathway is recurrently altered in these neoplasms, there are not pharmacological inhibitors officially approved for the treatment of T-ALL/LBL patients that present oncogenic JAK/STAT pathway mutations. In the effort to identify potential therapeutic targets for those patients, we followed an alternative approach and focused on their transcriptional profile. We combined the analysis of molecular data from T-ALL/LBL patients with the generation of hematopoietic cellular models to reveal that JAK/STAT pathway mutations are associated with an aberrant transcriptional profile. Specifically, we demonstrate that JAK/STAT pathway mutations induce the overexpression of the PIM1 gene. Moreover, we show that the pan-PIM inhibitor, PIM447, significantly reduces the leukemogenesis, as well as the aberrant activation of c-MYC and mTOR pathways in cells expressing different JAK/STAT pathway mutations, becoming a potential therapeutic opportunity for a relevant subset of T-ALL/LBL patients.
Gestational breast cancer: distinctive molecular and clinico-epidemiological features
(Springer, 2024-11-08) de la Haba-Rodríguez, J R; Mínguez, P; Rojo, F; Martín, M; Alba, E; Servitja, S; Prat, A; Pérez-Fidalgo, Jose Alejandro; Gavilá, J; Morales, C; Rodriguez-Lescure, A; Herrero, C; Peña-Enriquez, R; Herranz, J; Hernando, C; Hernández-Blanquisett, A; Guil-Luna, S; Martinez, M T; Blanch, S; Caballero, R; Martín, N; Pollan-Santamaria, Marina; Guerrero-Zotano, Ángel; Bermejo, B; Instituto de Salud Carlos III; University of Córdoba (España); Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF)
Gestational breast cancer (GBC), defined as breast cancer (BC) diagnosed during pregnancy or the first-year post-partum, accounts for 6-15% of BC cases in women aged 20-44 years. GBC has worse prognosis than non-GBC, but reasons behind are not clear. The GEICAM/2012-03 Study (Molecular Characterization of Gestational Breast Cancer) is a multicenter prospective/retrospective observational registry of patients diagnosed with GBC. From November 2014 to June 2015 seventy patients diagnosed with GBC were included in the study, 30 diagnosed during pregnancy and 40 after delivery. Our current study was aimed to explore differences in epidemiological, clinico-pathological and gene expression features of GBC tumors, from the GEICAM/2012-03 Study, compared to non-GBC tumors from patients of similar age (< 43 years) from six different GEICAM studies, used as non- GBC control population. As per the main objective, the study found multiple differences showing GBC tumors as a different biological entity. GBC showed a more aggressive biology, with higher Ki67 levels, higher incidence of breast and/or ovarian cancer family history, and germline deleterious BRCA1/2 mutations, and are enriched in basal-like intrinsic subtype. GBC patients showed a lower number of tumor infiltrating lymphocytes, while specific genetic signatures highlight differences in GBC´s distinctive transcriptome. Our study shows that GBC is potentially a clinically and molecularly different entity, with specific epidemiological, clinical, and histological features, as well as a distinctive altered immune state and genetic signature. Nevertheless, further studies are needed to better understand the biology of GBC and to identify new targets against which develop new, more effective, targeted therapies.
Preclinical development of three novel CARs targeting CD79b for the treatment of non-Hodgkin's lymphoma and characterization of the loss of the target antigen
(BMJ Publishing Group, 2024-12-18) Esquinas, Esperanza; Moreno-Sanz, Alvaro; Sandá, Victor; Stodulski-Ciesla, Damian; Borregón, Jennifer; Peña-Blanque, Virginia; Fernández-Calles, Javier; Fernandez-Fuentes, Narcis; Serrano-Lopez, Juana; Juan, Manel; Engel, Pablo; Llamas-Sillero, Pilar; Solán-Blanco, Laura; Martín-Antonio, Beatriz; Instituto de Salud Carlos III; Ministerio de Sanidad (España); Comunidad de Madrid (España)
Background: Infusion of T cells modified with a chimeric antigen receptor (CAR) targeting CD19 has achieved exceptional responses in patients with non-Hodgkin's lymphoma (NHL), which led to the approval of CAR targeting CD19 (CART19) (Axi-cel and Liso-cel) as second line of treatment for adult patients with relapsed/refractory NHL. Unfortunately, 60% of patients still relapse after CART19 due to either a loss of expression of the target antigen (CD19) in the tumor cell, observed in 27% of relapsed patients, a limited CAR-T persistence, and additional mechanisms, including the suppression of the tumor microenvironment. Clinic strategies to prevent target antigen loss include sequential treatment with CARs directed at CD20 or CD22, which have caused loss of the second antigen, suggesting targeting other antigens less prone to disappear. CD79b, expressed in NHL, is a target in patients treated with antibody-drug conjugates (ADC). However, the limited efficacy of ADC suggests that a CAR therapy targeting CD79b might improve results. Methods: We designed three new CARs against CD79b termed CAR for Lymphoma (CARLY)1, 2 and 3. We compared their efficacy, phenotype, and inflammatory profiles with CART19 (ARI0001) and CARTBCMA (ARI0002h), which can treat NHL. We also analyzed the target antigen's expression loss (CD79b, CD19, and B-cell maturation antigen(BCMA)). Results: We found that CARLY2 and CARLY3 had high affinity and specificity towards CD79b on B cells. In vitro, all CAR-T cells had similar anti-NHL efficacy, which was retained in an NHL model of CD19- relapse. In vivo, CARLY3 showed the highest efficacy. Analysis of the loss of the target antigen demonstrated that CARLY cells induced CD79b and CD19 downregulation on NHL cells with concomitant trogocytosis of these antigens to T cells, being most notorious in CARLY2, which had the highest affinity towards CD79b and CD19, and supporting the selection of CARLY3 to design a new treatment for patients with NHL. Finally, we created a CAR treatment based on dual targeting of CD79b and BCMA to avoid losing the target antigen. This treatment showed the highest efficacy and did not cause loss of the target antigen. Conclusions: Based on specificity, efficacy, and loss of the target antigen, CARLY3 represents a potential novel CAR treatment for NHL.
Global, regional, and national burden of stroke and its risk factors, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021
(Elsevier, 2024-10) GBD 2021 Stroke Risk Factor Collaborators; Padron-Monedero, Alicia; Bill & Melinda Gates Foundation
Background: Up-to-date estimates of stroke burden and attributable risks and their trends at global, regional, and national levels are essential for evidence-based health care, prevention, and resource allocation planning. We aimed to provide such estimates for the period 1990-2021. Methods: We estimated incidence, prevalence, death, and disability-adjusted life-year (DALY) counts and age-standardised rates per 100 000 people per year for overall stroke, ischaemic stroke, intracerebral haemorrhage, and subarachnoid haemorrhage, for 204 countries and territories from 1990 to 2021. We also calculated burden of stroke attributable to 23 risk factors and six risk clusters (air pollution, tobacco smoking, behavioural, dietary, environmental, and metabolic risks) at the global and regional levels (21 GBD regions and Socio-demographic Index [SDI] quintiles), using the standard GBD methodology. 95% uncertainty intervals (UIs) for each individual future estimate were derived from the 2·5th and 97·5th percentiles of distributions generated from propagating 500 draws through the multistage computational pipeline. Findings: In 2021, stroke was the third most common GBD level 3 cause of death (7·3 million [95% UI 6·6-7·8] deaths; 10·7% [9·8-11·3] of all deaths) after ischaemic heart disease and COVID-19, and the fourth most common cause of DALYs (160·5 million [147·8-171·6] DALYs; 5·6% [5·0-6·1] of all DALYs). In 2021, there were 93·8 million (89·0-99·3) prevalent and 11·9 million (10·7-13·2) incident strokes. We found disparities in stroke burden and risk factors by GBD region, country or territory, and SDI, as well as a stagnation in the reduction of incidence from 2015 onwards, and even some increases in the stroke incidence, death, prevalence, and DALY rates in southeast Asia, east Asia, and Oceania, countries with lower SDI, and people younger than 70 years. Globally, ischaemic stroke constituted 65·3% (62·4-67·7), intracerebral haemorrhage constituted 28·8% (28·3-28·8), and subarachnoid haemorrhage constituted 5·8% (5·7-6·0) of incident strokes. There were substantial increases in DALYs attributable to high BMI (88·2% [53·4-117·7]), high ambient temperature (72·4% [51·1 to 179·5]), high fasting plasma glucose (32·1% [26·7-38·1]), diet high in sugar-sweetened beverages (23·4% [12·7-35·7]), low physical activity (11·3% [1·8-34·9]), high systolic blood pressure (6·7% [2·5-11·6]), lead exposure (6·5% [4·5-11·2]), and diet low in omega-6 polyunsaturated fatty acids (5·3% [0·5-10·5]). Interpretation: Stroke burden has increased from 1990 to 2021, and the contribution of several risk factors has also increased. Effective, accessible, and affordable measures to improve stroke surveillance, prevention (with the emphasis on blood pressure, lifestyle, and environmental factors), acute care, and rehabilitation need to be urgently implemented across all countries to reduce stroke burden.
Microbial Phenolic Metabolites Are Associated with Improved Cognitive Health
(Wiley, 2024-01) Domínguez-López, Inés; Galkina, Polina; Parilli-Moser, Isabella; Arancibia-Riveros, Camila; Martínez-González, Miguel Ángel; Salas-Salvado, Jordi; Corella, Dolores; Malcampo, Mireia; Martínez, J Alfredo; Tojal-Sierra, Lucas; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; López-Miranda, José; Estruch, Ramon; Tinahones, Francisco J; Santos-Lozano, José Manuel; Serra-Majem, Lluis; Bueno-Cavanillas, Aurora; Tur, Josep A; Rubín-García, María; Pintó, Xavier; Fernández-Aranda, Fernando; Delgado-Rodríguez, Miguel; Barabash-Bustelo, Ana; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; Ros, Emilio; Toledo, Estefanía; Atzeni, Alessandro; Asensio, Eva M; Vera, Natàlia; Garcia-Rios, Antonio; Torres-Collado, Laura; Pérez-Farinós, Napoleón; Zulet, Marian; Chaplin, Alice; Casas, Rosa; Martín-Peláez, Sandra; Vaquero-Luna, Jessica; Gómez-Pérez, Ana Maria; Vazquez-Ruiz, Zenaida; Shyam, Sangeetha; Ortega-Azorín, Carolina; Talens, Natàlia; Peña-Orihuela, Patricia J; Oncina-Canovas, Alejandro; Diez-Espino, Javier; Babio, Nancy; Fitó, Montserrat; Lamuela-Raventós, Rosa M
Scope: Diets rich in polyphenols has been associated with better cognitive performance. The aim of this study is to assess the relationship between microbial phenolic metabolites (MPM) in urine and cognition in the context of an older population at high cardiovascular risk. Methods and results: A cross-sectional analysis is conducted in 400 individuals of the PREDIMED-Plus study. Liquid chromatography coupled to mass spectrometry is used to identify urinary MPM. Mediterranean diet (MedDiet) adherence is estimated with a 17-item questionnaire and cognitive function is evaluated with a battery of neuropsychological tests. Multivariable-adjusted linear regression models are fitted to assess the relationship of urinary MPM with the MedDiet and cognitive tests. Protocatechuic acid and enterolactone glucuronide are associated with higher adherence to the MedDiet. Regarding cognitive function, protocatechuic acid, vanillic acid glucuronide, 3-hydroxybenzoic acid, enterodiol glucuronide, and enterolactone glucuronide are directly associated with a global composite score of all the cognitive tests. Furthermore, protocatechuic acid and enterolactone glucuronide are associated with higher scores in the Mini-Mental State Examination, whereas enterodiol glucuronide is associated with improved Clock Drawing Test scores. Conclusions: These results suggest that the MedDiet is linked to MPM associated with better cognitive performance in an older population.
Association between type 2 diabetes and depressive symptoms after a 1-year follow-up in an older adult Mediterranean population
(Springer, 2024-01-13) Baenas, I; Camacho-Barcia, L; Granero, R; Razquin, C; Corella, D; Gómez-Martínez, Carlos; Castañer-Niño, O; Martínez, JA; Alonso-Gómez, ÁM; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; López-Miranda, J; Estruch, R; Tinahones, Francisco J; Lapetra, J; Serra-Majem, Lluis; Cano-Ibáñez, N; Tur, Josep A; Martín-Sánchez, V; Pintó, X; Gaforio, J J; Matía-Martín, P; Vidal, Josep; Vazquez, Clotilde; Daimiel, L; Ros, Emilio; Jiménez-Murcia, S; Dalsgaard, S; Garcia-Arellano, A; Babio, N; Sorli, Jose V; Lassale, C; García-de-la-Hera, M; Gómez-García, E; Zulet, MA; Konieczna, Jadwiga; Martín-Peláez, S; Tojal-Sierra, Lucas; Basterra-Gortari, FJ; de Las Heras-Delgado, S; Portoles, O; Muñoz-Pérez, MÁ; Arenas-Larriva, AP; Compañ-Gabucio, L; Eguaras, S; Shyam, Sangeetha; Fitó, M; Baños, RM; Salas-Salvado, Jordi; Fernández-Aranda, F
Objectives: To examine the cross-sectional association between baseline depressive symptoms and the presence of type 2 diabetes (T2D), and its association with glycated hemoglobin (HbA1c) and other metabolic variables, and the prospective association of depressive symptoms and HbA1c after 1 year of follow-up. Methods: n = 6224 Mediterranean older adults with overweight/obesity and metabolic syndrome (48% females, mean age 64.9 ± 4.9 years) were evaluated in the framework of the PREDIMED-Plus study cohort. Depressive symptoms were assessed using the Beck Depression Inventory-II and HbA1c was used to measure metabolic control. Results: The presence of T2D increased the likelihood of higher levels of depressive symptoms (χ2 = 15.84, p = 0.001). Polynomial contrast revealed a positive linear relationship (χ2 = 13.49, p = 0.001), the higher the depressive symptoms levels, the higher the prevalence of T2D. Longitudinal analyses showed that the higher baseline depressive symptoms levels, the higher the likelihood of being within the HbA1c ≥ 7% at 1-year level (Wald-χ2 = 24.06, df = 3, p < .001, for the full adjusted model). Additionally, depressive levels at baseline and duration of T2D predicted higher HbA1c and body mass index, and lower physical activity and adherence to Mediterranean Diet at 1 year of follow-up. Conclusions: This study supports an association between T2D and the severity of depressive symptoms, suggesting a worse metabolic control from mild severity levels in the short-medium term, influenced by lifestyle habits related to diabetes care. Screening for depressive symptoms and a multidisciplinary integrative therapeutic approach should be ensured in patients with T2D.
Ultra-processed foods consumption as a promoting factor of greenhouse gas emissions, water, energy, and land use: A longitudinal assessment
(Elsevier, 2023-05-24) Garcia, Silvia; Pastor, Rosario; Monserrat-Mesquida, Margalida; Álvarez-Álvarez, Laura; Rubín-García, María; Martínez-González, Miguel Ángel; Salas-Salvado, Jordi; Corella, Dolores; Fito, Montserrat; Martínez, J Alfredo; Tojal-Sierra, Lucas; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; López-Miranda, José; Estruch, Ramon; Tinahones, Francisco J; Santos-Lozano, José Manuel; Serra-Majem, Lluis; Cano-Ibañez, Naomi; Pintó, Xavier; Delgado-Rodriguez, Miguel; Matía-Martín, Pilar; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; Ros, Emilio; Buil-Cosiales, Pilar; Martínez-Rodríguez, María Ángeles; Coltell, Oscar; Castañer, Olga; Garcia-Rios, Antonio; Barceló Cañellas, María de la Concepión; Gómez-Gracia, Enrique; Zulet, Maria Ángeles; Konieczna, Jadwiga; Casas, Rosa; Massó-Guijarro, Paloma; Goicolea-Güemez, Leire; Rosa Bernal-Lopez, Maria; Bes-Rastrollo, Maira; Shyam, Sangeetha; González, José I; Zomeño-Fajardo, María Dolores; Peña-Orihuela, Patricia J; González-Palacios, Sandra; Toledo, Estefanía; Khoury, Nadine; Perez, Karla Alejandra; Martín-Sánchez, Vicente; Tur, Josep A; Bouzas, Cristina
Background: Dietary patterns can produce an environmental impact. Changes in people's diet, such as the increased consumption of ultra-processed food (UPF) can not only influence human health but also environment sustainability. Objectives: Assessment of the impact of 2-year changes in UPF consumption on greenhouse gas emissions and water, energy and land use. Design: A 2-year longitudinal study after a dietary intervention including 5879 participants from a Southern European population between the ages of 55-75 years with metabolic syndrome. Methods: Food intake was assessed using a validated 143-item food frequency questionnaire, which allowed classifying foods according to the NOVA system. In addition, sociodemographic data, Mediterranean diet adherence, and physical activity were obtained from validated questionnaires. Greenhouse gas emissions, water, energy and land use were calculated by means of the Agribalyse® 3.0.1 database of environmental impact indicators for food items. Changes in UPF consumption during a 2-year period were analyzed. Statistical analyses were conducted using computed General Linear Models. Results: Participants with major reductions in their UPF consumption reduced their impact by -0.6 kg of CO2eq and -5.3 MJ of energy. Water use was the only factor that increased as the percentage of UPF was reduced. Conclusions: Low consumption of ultra-processed foods may contribute to environmental sustainability. The processing level of the consumed food should be considered not only for nutritional advice on health but also for environmental protection. Trial registration: ISRCTN, ISRCTN89898870. Registered 05 September 2013, http://www.isrctn.com/ISRCTN89898870.
Increased ultra-processed food consumption is associated with worsening of cardiometabolic risk factors in adults with metabolic syndrome: Longitudinal analysis from a randomized trial
(Elsevier, 2023-06-07) González-Palacios, Sandra; Oncina-Cánovas, Alejandro; García-de-la-Hera, Manuela; Martínez-González, Miguel Ángel; Salas-Salvado, Jordi; Corella, Dolores; Schröder, Helmut; Martínez, J Alfredo; Alonso-Gómez, Ángel M; Wärnberg, Julia; Romaguera, Dora; López-Miranda, José; Estruch, Ramon; Tinahones, Francisco J; Lapetra, José; Serra-Majem, Lluis; Cano-Ibañez, Naomi; Tur, Josep A; Martín-Sánchez, Vicente; Pintó, Xavier; Delgado-Rodriguez, Miguel; Matía-Martín, Pilar; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; Ros, Emilio; Bes-Rastrollo, Maira; Atzeni, Alessandro; Sorli, Jose V; Zomeño-Fajardo, María Dolores; Peña-Orihuela, Patricia J; Compañ-Gabucio, Laura M; Barón-López, Francisco J; Zulet, María Ángeles; Konieczna, Jadwiga; Casas, Rosa M; Garrido-Garrido, Eva M; Tojal-Sierra, Lucas; Gomez-Perez, Ana M; Ruiz-Canela, Miguel; Palau-Galindo, Antoni; Saiz, Carmen; Pérez-Vega, Karla A; Garcia-Rios, Antonio; Torres-Collado, Laura; Basterra-Gortari, Javier; Garcidueñas-Fimbres, Tany E; Malcampo, Mireia; Vioque, Jesus
Background and aims: The association between changes in ultra-processed food (UPF) consumption and cardiometabolic risk (CMR) factors remains understudied. We evaluated the association between changes in UPF consumption over 12 months of follow-up and changes in CMR factors in adults diagnosed with metabolic syndrome. Methods: We analysed data from 5373 adults (aged 55-75 years) participating in the PREDIMED-Plus trial. Diet was evaluated at baseline, 6- and 12-month visits using a validated food frequency questionnaire, and UPF consumption (in grams/day and percentage of total daily dietary intake in grams) was categorized based on NOVA classification. We used mixed-effects linear models with repeated measurements at baseline, 6 and 12 months of follow-up to assess the associations between changes in UPF consumption and changes in CMR factors adjusting for sociodemographic and lifestyles variables. Results: In multivariable-adjusted models, when comparing the highest versus the lowest quartile of UPF consumption, positive associations were found for several CMR factors: weight (kg, β = 1.09; 95% confidence interval 0.91 to 1.26); BMI (kg/m2, β = 0.39; 0.33 to 0.46); waist circumference (cm, β = 1.03; 0.81 to 1.26); diastolic blood pressure (mm Hg, β = 0.67; 0.29 to 1.06); fasting blood glucose (mg/dl, β = 1.66; 0.61 to 2.70); HbA1c (%, β = 0.04; 0.01 to 0.07); triglycerides (mg/dl, β = 6.79; 3.66 to 9.91) and triglycerides and glucose index (β = 0.06; 0.04 to 0.08). Conclusions: Higher UPF consumption was associated with adverse evolution in objectively measured CMR factors after 12 months of follow-up in adults with metabolic syndrome. Further research is needed to explore whether these changes persist for longer periods.
How Did the COVID-19 Lockdown Pandemic Affect the Depression Symptomatology in Mediterranean Older Adults with Metabolic Syndrome?
(2023) Paz-Graniel, Indira; Babio, Nancy; Nishi, Stephanie K; Martínez-González, Miguel Ángel; Corella, Dolores; Fito, Montserrat; Martínez, Alfredo; Alonso-Gómez, Ángel M; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; López-Miranda, José; Estruch, Ramon; Tinahones, Francisco J; Santos-Lozano, José Manuel; Serra-Majem, Lluis; Bueno-Cavanillas, Aurora; Tur, Josep A; Sanchez, Vicente Martin; Pintó, Xavier; Delgado-Rodriguez, Miguel; Matía-Martín, Pilar; Vidal, Josep; Calderon-Sanchez, Cristina; Daimiel, Lidia; Ros, Emilio; Fernández-Aranda, Fernando; Toledo, Estefanía; Valle-Hita, Cristina; Sorli, Jose V; Lassale, Camille; Garcia-Rios, Antonio; Oncina-Canovas, Alejandro; Barón-López, Francisco Javier; Zulet, M. Angeles; Rayó, Elena; Casas, Rosa; Thomas-Carazo, Esther; Tojal-Sierra, Lucas; Damas-Fuentes, Miguel; Ruiz-Canela, Miguel; de Las Heras-Delgado, Sara; Fernandez-Carrion, Rebeca; Castañer, Olga; Peña-Orihuela, Patricia J; Gonzalez-Palacios, Sandra; Buil-Cosiales, Pilar; Goday, Albert; Salas-Salvado, Jordi
Background and Aims. To control the COVID-19 spread, in March 2020, a forced home lockdown was established in Spain. In the present study, we aimed to assess the effect of mobility and social COVID-19-established restrictions on depressive symptomatology in older adults with metabolic syndrome. We hypothesize that severe restrictions might have resulted in detrimental changes in depressive symptomatology. Methods. 2,312 PREDIMED-Plus study participants (men = 53:9%; mean age = 64:9 +/- 4:8 years) who completed a COVID-19 lockdown questionnaire to assess the severity of restrictions/lockdown and the validated Spanish version of the Beck Depression Inventory-II (BDI-II) during the three established phases concerning the COVID-19 lockdown in Spain (prelockdown, lockdown, and postlockdown) were included in this longitudinal analysis. Participants were categorized according to high or low lockdown severity. Analyses of covariance were performed to assess changes in depressive symptomatology across lockdown phases. Results. No significant differences in participant depression symptomatology changes were observed between lockdown severity categories (low/high) at the studied phases. During the lockdown phase, participants showed a decrease in BDI-II score compared to the prelockdown phase (mean (95% CI), -0.48 (-0.24, -0.72), P < 0:001); a nonsignificantly larger decrease was observed in participants allocated in the low-lockdown category (low: -0.59 (-0.95, -0.23), high: -0.43 (-0.67, -0.19)). Similar decreases in depression symptomatology were found for the physical environment dimension. The post- and prelockdown phase BDI-II scores were roughly similar. Conclusions. The COVID-19 pandemic lockdown was associated with a decrease in depressive symptomatology that returned to prelockdown levels after the lockdown. The degree of lockdown was not associated with depressive symptomatology. The potential preventive role of the physical environment and social interactions on mental disorders during forced home lockdown should be further studied. This trial is registered with ISRCTN89898870. Retrospectively registered on 24 July 2014.
Higher versus lower nut consumption and changes in cognitive performance over two years in a population at risk of cognitive decline: a cohort study
(Elsevier, 2023-06-01) Ni, Jiaqi; Nishi, Stephanie K; Babio, Nancy; Ros, Emilio; Basterra-Gortari, F Javier; Corella, Dolores; Castañer, O; Martínez, J Alfredo; Alonso-Gómez, Ángel M; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; López-Miranda, José; Estruch, Ramon; Tinahones, Francisco J; Santos-Lozano, José Manuel; Serra-Majem, Lluis; Cano-Ibáñez, Naomi; Tur, Josep A; Fernández-García, José Manuel; Pintó, Xavier; Delgado-Rodriguez, Miguel; Matía-Martín, Pilar; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; Fernández-Aranda, Fernando; Ruiz-Canela, Miguel; Mestres Solà, Cristina; Portolés, Olga; Sala-Vila, Aleix; Garcia-Rios, Antonio; Compañ-Gabucio, Laura María; Gómez-Gracia, Enrique; Zulet, M Angeles; Chaplin, Alice; Casas, Rosa; Martínez-Diz, Silvia; Tojal-Sierra, Lucas; Gómez-Pérez, Ana María; Toledo, Estefanía; Rios, Santiago; Ortega-Azorín, Carolina; de la Torre, Rafael; Peña-Orihuela, Patricia J; Garcia-de la Hera, Manuela; Sayon-Orea, Carmen; Malcampo, Mireia; Salas-Salvado, Jordi; Ni, Jiaqi; Nishi, Stephanie K; Babio, Nancy; Ros, Emilio; Basterra-Gortari, F Javier; Corella, Dolores; Castañer, O; Martínez, J Alfredo; Alonso-Gómez, Ángel M; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; López-Miranda, José; Estruch, Ramon; Tinahones, Francisco J; Santos-Lozano, José Manuel; Serra-Majem, Lluis; Cano-Ibáñez, Naomi; Tur, Josep A; Fernández-García, José Manuel; Pintó, Xavier; Delgado-Rodriguez, Miguel; Matía-Martín, Pilar; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; Fernández-Aranda, Fernando; Ruiz-Canela, Miguel; Mestres Solà, Cristina; Portolés, Olga; Sala-Vila, Aleix; Garcia-Rios, Antonio; Compañ-Gabucio, Laura María; Gómez-Gracia, Enrique; Zulet, M Angeles; Chaplin, Alice; Casas, Rosa; Martínez-Diz, Silvia; Tojal-Sierra, Lucas; Gómez-Pérez, Ana María; Toledo, Estefanía; Rios, Santiago; Ortega-Azorín, Carolina; de la Torre, Rafael; Peña-Orihuela, Patricia J; Garcia-de la Hera, Manuela; Sayon-Orea, Carmen; Malcampo, Mireia; Salas-Salvado, Jordi
Background: Tree nuts and peanuts (henceforth, nuts) are nutrient-dense foods rich in neuroprotective components; thus, their consumption could benefit cognitive health. However, evidence to date is limited and inconsistent regarding the potential benefits of nuts for cognitive function. Objective: To prospectively evaluate the association between nut consumption and 2-y changes in cognitive performance in older adults at cognitive decline risk. Methods: A total of 6,630 participants aged 55 to 75 y (mean age 65.0±4.9 y, 48.4% women) with overweight/obesity and metabolic syndrome completed a validated semi-quantitative food frequency questionnaire and a comprehensive battery of neuropsychological tests at baseline and a 2-y follow-up. Composite cognitive scores were used to assess global, general, attention, and executive function domains. Nut consumption was categorized as <1, ≥1 to <3, ≥3 to <7, and ≥7 servings/wk (1 serving=30 g). Multivariable-adjusted linear regression models were fitted to assess associations between baseline nut consumption and 2-y cognitive changes. Results: Nut consumption was positively associated with 2-y changes in general cognitive function (P-trend <0.001). Compared with participants consuming <1 serving/wk of nuts, those categorized as consuming ≥3 to <7 and ≥7 servings/wk showed more favorable changes in general cognitive performance (β z-score [95% CI] = 0.06 [0.00,0.12] and 0.13 [0.06,0.20], respectively). No significant changes were observed in the multivariable-adjusted models for other cognitive domains assessed. Conclusion: Frequent nut consumption was associated with a smaller decline in general cognitive performance over 2 y in older adults at risk of cognitive decline. Randomized clinical trials to verify our findings are warranted.
Dietary intake of polychlorinated dibenzo-p-dioxins and furans, adiposity and obesity status
(Elsevier, 2023-06-15) Khoury, Nadine; Martínez, María Ángeles; Paz-Graniel, Indira; Martínez-González, Miguel Ángel; Corella, Dolores; Castañer, Olga; Martínez, J Alfredo; Alonso-Gómez, Ángel M; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; López-Miranda, José; Estruch, Ramon; Tinahones, Francisco J; Lapetra, José; Serra-Majem, Lluis; Bueno-Cavanillas, Aurora; Tur, Josep A; Sanjurjo, Sergio Cinza; Pintó, Xavier; Gaforio, José Juan; Matía-Martín, Pilar; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; Ros, Emilio; Sayon-Orea, Carmen; Sorli, Jose V.; Pérez-Vega, Karla-Alejandra; Garcia-Rios, Antonio; Bellvert, Nuria Gómez; Gómez-Gracia, Enrique; Zulet, MA; Chaplin, Alice; Casas, Rosa; Salcedo-Bellido, Inmaculada; Tojal-Sierra, Lucas; Rosa Bernal-Lopez, Maria; Vazquez-Ruiz, Zenaida; Asensio, Eva M; Goday, Albert; Peña-Orihuela, Patricia J; Signes-Pastor, Antonio J; Garcia-Arellano, Ana; Fito, Montserrat; Babio, Nancy; Salas-Salvado, Jordi
Introduction: The principal source of exposure to Polychlorinated dibenzo-p-dioxins and polychlorinated dibenzo-p-furans (PCDD/Fs) in humans comes from food intake. PCDD/Fs, are a family of potential endocrine disruptors and have been associated with different chronic diseases such as diabetes and hypertension. However, studies assessing the relationship between dietary exposure to PCDD/Fs and adiposity or obesity status in a middle-aged population are limited. Objective: To assess cross-sectionally and longitudinally the associations between estimated dietary intake (DI) of PCDD/Fs and body mass index (BMI), waist circumference, and the prevalence/incidence of obesity and abdominal obesity in a middle-aged population. Methods: In 5899 participants aged 55-75 years (48% women) living with overweight/obesity from the PREDIMED-plus cohort, PCDD/Fs DI was estimated using a 143-item validated food-frequency questionnaire, and the levels of food PCDD/F expressed as Toxic Equivalents (TEQ). Consequently, cross-sectional and prospective associations between baseline PCDD/Fs DI (in pgTEQ/week) and adiposity or obesity status were assessed at baseline and after 1-year follow-up using multivariable cox, logistic or linear regression models. Results: Compared to participants in the first PCDD/F DI tertile, those in the highest tertile presented a higher BMI (β-coefficient [confidence interval]) (0.43kg/m2 [0.22; 0.64]; P-trend <0.001), a higher waist circumference (1.11 cm [0.55; 1.66]; P-trend <0.001), and a higher prevalence of obesity and abdominal obesity (1.05 [1.01; 1.09] and 1.02 [1.00; 1.03]; P-trend = 0.09 and 0.027, respectively). In the prospective analysis, participants in the top PCDD/F DI baseline tertile showed an increase in waist circumference compared with those in the first tertile after 1-year of follow-up (β-coefficient 0.37 cm [0.06; 0.70]; P-trend = 0.015). Conclusion: Higher DI of PCDD/Fs was positively associated with adiposity parameters and obesity status at baseline and with changes in waist circumference after 1-year of follow-up in subjects living with overweight/obesity. Further large prospective studies using a different population with longer follow-up periods are warranted in the future to strengthen our results.
Association of adiposity and its changes over time with COVID-19 risk in older adults with overweight/obesity and metabolic syndrome: a longitudinal evaluation in the PREDIMED-Plus cohort
(BioMed Central (BMC), 2023-10-13) Shyam, Sangeetha; García-Gavilán, Jesús Francisco; Paz-Graniel, Indira; Gaforio, José J; Martínez-González, Miguel Ángel; Corella, Dolores; Martínez, J Alfredo; Alonso-Gómez, Ángel M; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; López-Miranda, José; Estruch, Ramon; Tinahones, Francisco J; Lapetra, José; Serra-Majem, Lluis; Bueno-Cavanillas, Aurora; Tur, Josep A; Sanchez, Vicente Martin; Pintó, Xavier; Matía-Martín, Pilar; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; Ros, Emilio; Fernandez-Aranda, Fernando; Nishi, Stephanie K; Garcia-Regata, Oscar; Toledo, Estefanía; Asensio, Eva M; Castañer, Olga; Garcia-Rios, Antonio; Torres-Collado, Laura; Gómez-Gracia, Enrique; Zulet, M Angeles; Goñi-Ruiz, Nuria; Casas, Rosa; Cano-Ibáñez, Naomi; Tojal-Sierra, Lucas; Gómez-Perez, A M; Sorli, Jose V; Cinza-Sanjurjo, Sergio; Martín-Peláez, Sandra; Peña-Orihuela, Patricia J; Oncina-Canovas, Alejandro; Perez-Araluce, Rafael; Zomeño, María Dolores; Chaplin, Alice; Delgado-Rodríguez, Miguel; Babio, Nancy; Fitó, Montserrat; Salas-Salvado, Jordi
Background: Cross-sectionally, older age and obesity are associated with increased coronavirus disease-2019 (COVID-19) risk. We assessed the longitudinal associations of baseline and changes in adiposity parameters with COVID-19 incidence in older adults at high cardiovascular risk. Methods: This analysis included 6874 men and women (aged 55-75 years) with overweight/obesity and metabolic syndrome in the PREDIMED-Plus lifestyle intervention trial for cardiovascular risk reduction. Body weight, body-mass-index (BMI), waist circumference, waist-to-height ratio (WHtR), and a body shape index (ABSI) were measured at baseline and annual follow-up visits. COVID-19 was ascertained by an independent Event Committee until 31 December 2021. Cox regression models were fitted to evaluate the risk of COVID-19 incidence based on baseline adiposity parameters measured 5-6 years before the pandemic and their changes at the visit prior to censoring. Results: At the time of censoring, 653 incident COVID-19 cases occurred. Higher baseline body weight, BMI, waist circumference, and WHtR were associated with increased COVID-19 risk. During the follow-up, every unit increase in body weight (HRadj (95%CI): 1.01 (1.00, 1.03)) and BMI (HRadj: 1.04 (1.003, 1.08)) was associated with increased COVID-19 risk. Conclusions: In older adults with overweight/obesity, clinically significant weight loss may protect against COVID-19. Trial registration: This study is registered at the International Standard Randomized Controlled Trial (ISRCT; http://www.isrctn.com/ISRCTN89898870).
Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity
(Frontiers Media, 2022) Paz-Graniel, Indira; Fito, Montserrat; Ros, Emilio; Buil-Cosiales, Pilar; Corella, Dolores; Babio, Nancy; Martínez, J Alfredo; Alonso-Gómez, Ángel M; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; López-Miranda, José; Estruch, Ramon; Tinahones, Francisco J; Lapetra, José; Serra-Majem, Lluis; Bueno-Cavanillas, Aurora; Tur, Josep A; Martín-Sánchez, Vicente; Pintó, Xavier; Gaforio, José Juan; Matía-Martín, Pilar; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; García-Gavilán, Jesus F; Toledo, Estefanía; Nishi, Stephanie K; Sorli, Jose V; Castañer, Olga; García-Ríos, Antonio; Garcia de la Hera, Manoli; Barón-López, Francisco Javier; Ruiz-Canela, Miguel; Morey, Margalida; Casas, Rosa; Garrido-Garrido, Eva María; Tojal-Sierra, Lucas; Fernández-García, José Carlos; Vazquez-Ruiz, Zenaida; Fernandez-Carrion, Rebeca; Goday, Albert; Peña-Orihuela, Patricia J; Compañ-Gabucio, Laura; Schröder, Helmut; Martínez-Gonzalez, Miguel A; Salas-Salvado, Jordi
Background: The COVID-19 pandemic has affected the implementation of most ongoing clinical trials worldwide including the PREDIMED-Plus study. The PREDIMED-Plus is an ongoing, multicenter, controlled intervention trial, aimed at weight-loss and cardiovascular disease prevention, in which participants were randomized (1:1 ratio) to an intervention group (energy-reduced Mediterranean diet, promotion of physical activity, and behavioral support) or to a control group (Mediterranean diet with usual care advice). When the pandemic began, the trial was in the midst of the planned intervention. The objective of this report was to examine the effects of the pandemic on the delivery of the intervention and to describe the strategies established to mitigate the possible adverse effects of the pandemic lockdown on data collection and adiposity. Methods: We assessed the integrity of the PREDIMED-Plus trial during 5 identified periods of the COVID-19 pandemic determined according to restrictions dictated by the Spanish government authorities. A standardized questionnaire was delivered to each of the 23 PREDIMED-Plus recruiting centers to collected data regarding the trial integrity. The effect of the restrictions on intervention components (diet, physical activity) was evaluated with data obtained in the three identified lockdown phases: pre lockdown, lockdown proper, and post lockdown. Results: During the lockdown (March/2020-June/2021), 4,612 participants (48% women, mean age 65y) attended pre-specified yearly follow-up visits to receive lifestyle recommendations and obtain adiposity measures. The overall mean (SD) of the proportions reported by each center showed that 40.4% (25.4) participants had in-person visits, 39.8% (18.2) participants were contacted by telephone and 35% (26.3) by electronic means. Participants' follow-up and data collection rates increased across lockdown periods (from ≈10% at onset to ≈80% at the end). Compared to pre-lockdown, waist circumference increased during (0.75 cm [95% CI: 0.60-0.91]) and after (0.72 cm [95% CI: 0.56-0.89]) lockdown. Body weight did not change during lockdown (0.01 kg [95% CI: -0.10 to 0.13) and decreased after lockdown (-0.17 kg [95% CI: -0.30 to -0.04]). Conclusion: Mitigating strategies to enforce the intervention and patient's follow-up during lockdown have been successful in preserving the integrity of the trial and ensuring its continuation, with minor effects on adiposity. Clinical trial registration: https://doi.org/10.1186/ISRCTN89898870, identifier ISRCTN89898870.
Fruit and Vegetable Consumption is Inversely Associated with Plasma Saturated Fatty Acids at Baseline in Predimed Plus Trial
(Wiley, 2021-09) Domínguez-López, Inés; Marhuenda-Munoz, Maria; Tresserra-Rimbau, Anna; Hernaez, Alvaro; Moreno, Juan Jose; Martinez-Gonzalez, Miguel Angel; Salas-Salvado, Jordi; Corella, Dolores; Fito, Montserrat; Martinez, Jose Alfredo; Alonso-Gomez, Angel M; Wärnberg, Julia; Vioque, Jesus; Romaguera, Dora; Lopez-Miranda, Jose; Bernal-Lopez, Maria Rosa; Lapetra, Jose; Serra-Majem, Lluis; Bueno-Cavanillas, Aurora; Tur, Josep A; Martín-Sánchez, Vicente; Pinto, Xavier; Delgado-Rodriguez, Miguel; Matia-Martin, Pilar; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; Serra-Mir, Merce; Vazquez-Ruiz, Zenaida; Nishi, Stephanie K; Sorli, Jose V; Castaner, Olga; Abete, Itziar; Vaquero Luna, Jessica; Carabano-Moral, Rosa; Asencio, Alberto; Prohens, Lara; Garcia-Rios, Antonio; Casas, Rosa; Gomez-Perez, Ana Maria; Santos-Lozano, Jose Manuel; Razquin, Cristina; Martinez, Maria Angeles; Saiz, Carmen; Robledo-Pastor, Vanesa; Zulet, Maria Angeles; Salaverria-Lete, Itziar; Eguaras, Sonia; Babio, Nancy; Malcampo, Mireia; Ros, Emilio; Estruch, Ramon; Lopez-Sabater, M Carmen; Lamuela-Raventos, Rosa M
Scope Plasma fatty acids (FAs) are associated with the development of cardiovascular diseases and metabolic syndrome. The aim of our study is to assess the relationship between fruit and vegetable (F&V) consumption and plasma FAs and their subtypes. Methods and Results Plasma FAs are assessed in a cross-sectional analysis of a subsample of 240 subjects from the PREDIMED-Plus study. Participants are categorized into four groups of fruit, vegetable, and fat intake according to the food frequency questionnaire. Plasma FA analysis is performed using gas chromatography. Associations between FAs and F&V consumption are adjusted for age, sex, physical activity, body mass index (BMI), total energy intake, and alcohol consumption. Plasma saturated FAs are lower in groups with high F&V consumption (-1.20 mg cL(-1) [95% CI: [-2.22, -0.18], p-value = 0.021), especially when fat intake is high (-1.74 mg cL(-1) [95% CI: [-3.41, -0.06], p-value = 0.042). Total FAs and n-6 polyunsaturated FAs tend to be lower in high consumers of F&V only in the high-fat intake groups. Conclusions F&V consumption is associated with lower plasma saturated FAs when fat intake is high. These findings suggest that F&V consumption may have different associations with plasma FAs depending on their subtype and on the extent of fat intake.
Anthropometric Variables as Mediators of the Association of Changes in Diet and Physical Activity With Inflammatory Profile
(Oxford University Press, 2021-10-13) Cárdenas-Fuentes, Gabriela; Lassale, Camille; Martínez-González, Miguel Ángel; Grau, María; Salas-Salvado, Jordi; Corella, Dolores; Serra-Majem, Lluis; Warnberg, Julia; Konieczna, Jadwiga; Estruch, Ramon; Pintó, Xavier; Martínez, J Alfredo; Vázquez, Clotilde; Vidal, Josep; Tur, Josep A; Diaz-Lopez, Andres; Lancova, Hana; Fito, Montserrat; Schröder, Helmut
Mechanisms underlying the associations of high levels of physical activity (PA) and adherence to the Mediterranean diet (MedDiet) with a better inflammatory profile remain unclear. Our objective was to assess the mediating role of changes in body mass index (BMI) and waist circumference (WC), as markers of body fat in the association of changes in PA and adherence to the MedDiet, with changes in the inflammatory profile. This study included 489 adults, aged 55-75 years, from the PREDIMED-Plus multicenter lifestyle intervention trial. An inflammatory score was calculated, based on 8 blood biomarkers: high-sensitivity C-reactive protein, interleukin 6, interleukin 8, interleukin 18, monocyte chemo-attractant protein-1, C-peptide, leptin, and regulated on activation, normal T-cell-expressed and secreted chemokine. Biomarkers, levels of PA, score of MedDiet adherence, BMI, and WC were measured at baseline and at 1-year follow-up. Linear regression models were fitted according to the Baron and Kenny framework for mediation analysis. Changes in BMI and WC mediated the association of both changes in PA and changes in the MedDiet adherence with the inflammatory score. Body mass index mediated 26% of the association of changes in total PA with the inflammatory profile, and 27% of the association of changes in the MedDiet, while WC mediated 13% and 12% of these associations, respectively. In older adults at high cardiovascular risk, increasing PA levels and adherence to a MedDiet during 1 year were associated with a lower inflammatory score, which was partly mediated by a reduction in body fat. International Standard Randomized Controlled Trial Number: ISRCTN89898870; registration date July 24, 2014, retrospectively registered.
Mediterranean, DASH, and MIND Dietary Patterns and Cognitive Function: The 2-Year Longitudinal Changes in an Older Spanish Cohort
(Frontiers Media, 2021-12-13) Nishi, Stephanie K; Babio, Nancy; Gomez-Martinez, Carlos; Martinez-Gonzalez, Miguel Angel; Ros, Emilio; Corella, Dolores; Castaner, Olga; Martinez, J. Alfredo; Alonso-Gomez, Angel M; Waernberg, Julia; Vioque, Jesus; Romaguera, Dora; Lopez-Miranda, Jose; Estruch, Ramon; Tinahones, Francisco J; Lapetra, Jose; Serra-Majem, Lluis; Bueno-Cavanillas, Aurora; Tur, Josep A; Martin Sanchez, Vicente; Pinto, Xavier; Delgado-Rodriguez, Miguel; Matia-Martin, Pilar; Vidal, Josep; Vazquez, Clotilde; Daimiel, Lidia; Razquin, Cristina; Coltell, Oscar; Becerra-Tomas, Nerea; de la Torre, Rafael; Abete, Itziar; Sorto-Sanchez, Carolina; Baron-Lopez, Francisco Javier; Signes-Pastor, Antonio J; Konieczna, Jadwiga; Garcia-Rios, Antonio; Casas, Rosa; Gomez-Perez, Ana Maria; Santos-Lozano, José Manuel; Garcia-Arellano, Ana; Guillem-Saiz, Patricia; Ni, Jiaqi; Soria-Florido, Maria Trinidad; Zulet, M. Angeles; Vaquero-Luna, Jessica; Toledo, Estefanía; Fito, Montserrat; Salas-Salvado, Jordi
Background and Aims: Plant-forward dietary patterns have been associated with cardiometabolic health benefits, which, in turn, have been related to cognitive performance with inconsistent findings. The objective of this study was to examine the relationship between baseline adherence to three a priori dietary patterns (Mediterranean, DASH, and MIND diets) with 2-year changes in cognitive performance in older adults with overweight or obesity and high cardiovascular disease risk.Methods: A prospective cohort analysis was conducted within the PREDIMED-Plus trial, involving 6,647 men and women aged 55-75 years with overweight or obesity and metabolic syndrome. Using a validated, semiquantitative 143-item food frequency questionnaire completed at baseline, the dietary pattern adherence scores were calculated. An extensive neuropsychological test battery was administered at baseline and 2-year follow-up. Multivariable-adjusted linear regression models were used to assess associations between 2-year changes in cognitive function z-scores across tertiles of baseline adherence to the a priori dietary patterns.Results: Adherence to the Mediterranean diet at baseline was associated with 2-year changes in the general cognitive screening Mini-Mental State Examination (MMSE, beta: 0.070; 95% CI: 0.014, 0.175, P-trend = 0.011), and two executive function-related assessments: the Trail Making Tests Part A (TMT-A, beta: -0.054; 95% CI: -0.110, - 0.002, P-trend = 0.047) and Part B (TMT-B, beta: -0.079; 95% CI: -0.134, -0.024, P-trend = 0.004). Adherence to the MIND diet was associated with the backward recall Digit Span Test assessment of working memory (DST-B, beta: 0.058; 95% CI: 0.002, 0.114, P-trend = 0.045). However, higher adherence to the DASH dietary pattern was not associated with better cognitive function over a period of 2 years.Conclusion: In older Spanish individuals with overweight or obesity and at high cardiovascular disease risk, higher baseline adherence to the Mediterranean dietary pattern may be associated with better cognitive performance than lower adherence over a period of 2 years.

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