Nuts4Brain-RCT: Protocol for a Three-Arm Randomized Controlled Trial Examining the Dose–Response Effects of Nut Consumption on Mental Health in Young Adults
Year: 2026
Type: article
Study design: Study Protocol
Abstract: Introduction: Mental disorders, particularly depression and anxiety, represent a leading source of morbidity and disability in young adults, a group increasingly exposed to cumulative psychological processes and environmental stressors. Although evidence links healthy dietary patterns with improved mental health symptoms, the specific contribution of nut consumption (rich in anti-inflammatory, antioxidant, and neuroprotective compounds) remains insufficiently examined in this population. Current evidence also lacks robust data on the dose–response effects of nut consumption and mechanistic pathways involving biomarkers relevant to brain function and mental health. The Nuts4Brain-RCT will investigate the impact of a 6-month mixed-nut consumption intervention on mental health symptoms, cognitive functioning, sleep quality, overall well-being, health-related quality of life, and biochemical brain function mediators in young adults. Methods and analysis: A 6-month, randomized, single-blinded, three-arm, dose–response, parallel-group clinical trial will be conducted with 135 university students aged 18–24 years from the University of Castilla-La Mancha, Cuenca, Spain. The participants will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) a control group maintaining their habitual diet while avoiding nut consumption; (2) a 30 g/day mixed-nut consumption group; or (3) a 60 g/day mixed-nut consumption group. The nut consumption intervention will include unsalted, unroasted walnuts, almonds, hazelnuts, and pistachios. The primary outcomes will include depressive (BDI-II) and anxiety (GAD-7) symptoms, perceived stress (PSS-10), cognitive performance (NIH Toolbox), and plasma brain-derived neurotrophic factor (BDNF). Assessments will take place at baseline and at 3 (intermediate), 6 (end of intervention) and 12 months (follow-up). Repeated-measures mixed-effects models will be applied to estimate the effects of nut consumption and dosage on mental health outcomes. Ethics and dissemination: The study adheres to the principles of the Declaration of Helsinki and the Singapore Statement on Research Integrity and obtained approval from the Clinical Research Ethics Committee of the Virgen de la Luz Hospital, Cuenca, Spain (REG: 2025/E0125). The findings will be disseminated through high-impact open-access peer-reviewed publications, presentations at scientific conferences, and social media platforms. Trial registration: ClinicalTrials.gov. Identifier: NCT07292610.
Source: Healthcare
Authors: Arthur Eumann Mesas, Fernando Peral-Martínez, Tomás Olivo-Martins-de-Passos, Estela Jiménez-López, Nuria Beneit, Isabel Antonia Martínez-Ortega, Valentina Díaz-Goñi, Sandra Herraiz-Garrote, Irene Martínez-García, David Casanova-Rodríguez, Eva Rodríguez-Gutiérrez, Bruno Bizzozero-Peroni, Ana Ballesta-Castillejos, Shkelzen Cekrezi, Irene Marcilla-Toribio, Sergio Núñez de Arenas-Arroyo, Carlos Álvarez-Herraiz, Carla Soraya Costa Maia, Soraia Pinheiro Machado, Luis Felipe Nunes de Oliveira, Sandra Serrano-Martínez, Vanessa Martínez-Madrid, María Concepción Calderón-Alva, José Francisco López-Gil, Rubén Fernández-Rodríguez, Cristina Cadenas-Sánchez, María Medrano, María Eugenia Visier-Alfonso, Vicente Martínez-Vizcaíno, Miriam Garrido-Miguel
Institutions: University of Castilla-La Mancha, Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental, University of Córdoba, Servicio de Salud de Castilla La Mancha, Stockholm University, Universidad de la República de Uruguay, Karolinska Institutet, Regional Government of Castile-La Mancha, Universidade Estadual do Ceará, Universidad Espíritu Santo, Universidad de Los Lagos, Deakin University, Flinders University, Universidad de Granada, Spanish Biomedical Research Centre in Physiopathology of Obesity and Nutrition, Centro de Investigación Biomédica en Red, Universidad Pública de Navarra (UPNA), Instituto de Innovación y Sostenibilidad en la Cadena Agroalimentaria, Universidad de Navarra, Universidad Autónoma de Chile
Language: English
Topic: Nuts composition and effects
Subfield: Nutrition and Dietetics
Field: Nursing
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,258
OpenAlex ID: W7128383333
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