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Recruiting NCT07292610

Impact of Nut Consumption on Mental Health in Young Adults

No phase Interventional Depression Disorder Anxiety Mental Health Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mixed nuts. Group A, mixed nuts. Group B, control group.
Who it may be relevant to
Registry conditions: Depression Disorder, Anxiety, Mental Health, Stress. Basic parameters: 18 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Impact of Nut Consumption on Mental Health in Young Adults: a Randomized Controlled Trial

Overview

Nuts have a high nutrient density, and numerous studies have reported their cardiometabolic benefits. Although observational studies in adults have indicated a potential link between nut consumption and improved mental health, there is still insufficient evidence from experimental studies to draw firm conclusions about this association.

Detailed description

Nuts are widely recognized for their high nutrient density and their multiple reported cardiometabolic benefits. They are rich in monounsaturated (MUFAs) and polyunsaturated (PUFAs) fatty acids (including omega-3 alpha-linolenic acid and omega-6 linoleic acid) as well as antioxidants and compounds with anti inflammatory properties. Observational studies in adults have suggested a potential association between nut consumption and improved mental health, including a reduced risk of depression and enhanced mood. However, evidence from experimental studies remains limited and often inconclusive.

Early adulthood (ages 18-24) represents a critical developmental period marked by substantial physical, psychological, and social changes, and it is also a stage during which mental health problems commonly emerge.

The Nuts4Brain-RCT will investigate the impact of a 6-month mixed-nut intervention on mental health symptoms, cognitive functioning, sleep quality, overall well-being, health-related quality of life, and biochemical mediators of brain function and mental health in young adults.

Interventions

  • Dietary supplement mixed nuts. Group A
    Participants will be instructed to consume a single daily dose of nuts (30 g/day of mixed nuts). Nuts will be provided free of charge for the entire study period (6 moths). The participants will be instructed to incorporate nuts into their regular diet and consume them in any way they prefer. Upon completion of the intervention, participants will be instructed to continue their usual dietary and lifestyle habits, without any specific restrictions or incentives directed toward nut consumption. A
  • Dietary supplement mixed nuts. Group B
    Participants will be instructed to consume two daily doses of nuts (60 g/day of mixed nuts). Nuts will be provided free of charge for the entire study period (6 months). The participants will be instructed to incorporate nuts into their regular diet and consume them in any way they prefer.Upon completion of the intervention, participants will be instructed to continue their usual dietary and lifestyle habits, without any specific restrictions or incentives directed toward nut consumption. After
  • Other control group
    Participants will be instructed to maintain their regular diet without any specific dietary instructions or intervention.

Primary outcome measures

  • Depression [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Anxiety [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Stress [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Episodic memory [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Working memory [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Cognitive flexibility [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Processing speed [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Inhibitory control and attention [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Brain Derived Neurotrophic Factor [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
Secondary outcome measures (12)
  • Sleep quality [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Health-related quality of life (HRQL) [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Inflammatory biomarkers [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Concentration of vitamins and minerals [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Body image [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Screen time [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Social media addiction [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Sociodemographic [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Drugs consumption [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Adherence to the Mediterranean Diet [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Resilience [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Risk of eating disorders [Time frame: "Day 0", "Month 3", "Month 6", "Month 12"]

Eligibility criteria

Participants must meet all the following criteria to be considered eligible for selection and randomization:

Inclusion criteria

  • Age: Participants must be between 18 and 25 years old.
  • Academic Status: Participants must be enrolled as university students.
  • Field of Study: Participants may come from any academic program offered at the Cuenca Campus, including Nursing, Social Work, Education, Fine Arts, Engineering, Journalism, and Teaching.

Participants will be excluded from the study if they have any of the following conditions, based on self-reported information:

Exclusion criteria

  • Allergies: Known nut allergy.
  • Self-reported cardiovascular, metabolic, gastrointestinal or mental health disorder.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Health and Social Research Center. University of Castilla-La Mancha — Cuenca

Publications

  • Mesas AE, Peral-Martinez F, Olivo-Martins-de-Passos T, Jimenez-Lopez E, Beneit N, Martinez-Ortega IA, Diaz-Goni V, Herraiz-Garrote S, Martinez-Garcia I, Casanova-Rodriguez D, Rodriguez-Gutierrez E, Bizzozero-Peroni B, Ballesta-Castillejos A, Cekrezi S, Marcilla-Toribio I, Nunez de Arenas-Arroyo S, Alvarez-Herraiz C, Maia CSC, Machado SP, Oliveira LFN, Serrano-Martinez S, Martinez-Madrid V, Caldero PMID 41753948

Identifiers

NCT: NCT07292610 · SBPLY/23/180225/000177 · SBPLY/23/180225/000177

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗