Impact of Nut Consumption on Mental Health in Young Adults

NCT07292610 | Recruiting

• 1 other identifier: SBPLY/23/180225/000177
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

General Wellbeing; Depression Disorder; Anxiety; Mental Health; Stress; Cognition; BDNF

Keywords

RCT; Dietary Intervention; Nut consumption; young adults; Randomized controlled trial; Mental Health; Depression; Anxiety; Cognition; University students; Sleep quality; Academic performance; Walnuts; Almonds; Pistachios; Hazelnut; BDNF

Outcome Measures

Primary Outcomes (9)

• Depression

  Changes in symptoms of depression assessed with the Beck Depression Inventory Version II (BDI-II). Each of the 21 items includes four statements of increasing severity, and a total score (ranging from 0 to 63) is calculated, with higher scores indicating more severe depression.

  "Day 0", "Month 3", "Month 6", "Month 12"

• Anxiety

  Changes in symptoms of anxiety assessed with The Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 consists of seven questions asking individuals to rate the frequency and severity of specific anxiety symptoms over the past two weeks.The total score ranges from 0 to 21, calculated by summing the scores of all seven items. A score of 10 or greater is considered a reasonable cut-off point for identifying possible cases of GAD that may require further clinical evaluation

  "Day 0", "Month 3", "Month 6", "Month 12"

• Stress

  Changes in symptoms of stress assessed with The Perceived Stress Scale (PSS-10). The PSS-10 is a widely used, 10-item self-report questionnaire that measures an individual's perception of stress over the past month. Scoring involves reverse-scoring four positive items and summing all 10. Total scores range from 0 to 40, with higher scores indicating more perceived stress. Scores can be interpreted generally as low (0-13), moderate (14-26), or high (27-40) stress.

  "Day 0", "Month 3", "Month 6", "Month 12"

• Episodic memory

  The Picture Sequence Memory Test assesses episodic memory by requiring participants to encode and recall the temporal order of a sequence of visually presented everyday events. After presentation, individuals are asked to reconstruct the sequence in its original order, allowing evaluation of visual episodic memory and learning across trials. Test time: 7 minutes. This test is one of the measures included in the NIH Toolbox Cognition Battery, which is administered on an iPad by qualified personnel.

  "Day 0", "Month 3", "Month 6", "Month 12"

• Working memory

  The List Sorting Working Memory Test (LSWM), part of the NIH Toolbox Cognition Batery, assesses working memory by having individuals recall and sequence visually and auditorily presented stimuli (like animal/food pictures) in size order (smallest to largest). Test time: 7 minutes.

  "Day 0", "Month 3", "Month 6", "Month 12"

• Cognitive flexibility

  The Dimensional Change Card Sort Test is a standardized measure of cognitive flexibility. Participants are required to sort cards according to different rules (e.g., color or shape) and to adapt their responses when the sorting dimension changes. Test time: 5 minutes. This test is one of the tests that will be determined using the NIH Toolbox Cognition Battery, which will be administered on an iPad by qualified personnel.

  "Day 0", "Month 3", "Month 6", "Month 12"

• Processing speed

  The Pattern Comparison Processing Speed Test is a standardized measure of processing speed. Participants are asked to quickly determine whether two visual patterns are the same or different, emphasizing speed and accuracy of visual perception and decision-making. Test Time: 4 minutes. This test is one of the tests that will be determined using the NIH Toolbox Cognition Battery, which will be administered on an iPad by qualified personnel.

  "Day 0", "Month 3", "Month 6", "Month 12"

• Inhibitory control and attention

  The Flanker Inhibitory Control and Attention Test is a standardized measure of inhibitory control and selective attention, core components of executive function. Participants are required to focus on a central target stimulus while inhibiting interference from surrounding distractor stimuli. Performance reflects the ability to maintain attention, suppress competing responses, and resolve cognitive conflict. Test Time: 3 minutes. This test is one of the tests that will be determined using the NIH Toolbox Cognition Battery, which will be administered on an iPad by qualified personnel.

  "Day 0", "Month 3", "Month 6", "Month 12"

• Brain Derived Neurotrophic Factor

  Changes in blood concentration of brain-derived neurotrophic factor (BDNF), a biochemical mediator of brain functioning

  "Day 0", "Month 3", "Month 6", "Month 12"

Secondary Outcomes (23)

• Sleep quality

  "Day 0", "Month 3", "Month 6", "Month 12"

• Health-related quality of life (HRQL)

  "Day 0", "Month 3", "Month 6", "Month 12"

• Inflammatory biomarkers

  "Day 0", "Month 3", "Month 6", "Month 12"

• Concentration of vitamins and minerals

  "Day 0", "Month 3", "Month 6", "Month 12"

• Body image

  "Day 0", "Month 3", "Month 6", "Month 12"

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Usual dietary habits.

Other: control group

Intervention Group A

EXPERIMENTAL

Nut consumption (walnuts, almonds, pistachios, and hazelnuts mix).

Dietary Supplement: mixed nuts. Group A

Intervention Group B

EXPERIMENTAL

Nut consumption (walnuts, almonds, pistachios, and hazelnuts mix).

Dietary Supplement: mixed nuts. Group B

Interventions

mixed nuts. Group A DIETARY_SUPPLEMENT

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. After 6 months have passed since the end of the intervention, all participants will be called for a final session (12 months) in which all data evaluated throughout the study will be collected

Intervention Group A

mixed nuts. Group B DIETARY_SUPPLEMENT

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 6 months have passed since the end of the intervention, all participants will be called for a final session (12 months) in which all data evaluated throughout the study will be collected

Intervention Group B

control group OTHER

Participants will be instructed to maintain their regular diet without any specific dietary instructions or intervention.

Control Group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• European Union: collaborator

Study Sites (1)

Health and Social Research Center. University of Castilla-La Mancha

Cuenca, Cuenca, 16071, Spain

RECRUITING

Related Publications (1)

• 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, Calderon-Alva MC, Lopez-Gil JF, Fernandez-Rodriguez R, Cadenas-Sanchez C, Medrano M, Visier-Alfonso ME, Martinez-Vizcaino V, Garrido-Miguel M. Nuts4Brain-RCT: Protocol for a Three-Arm Randomized Controlled Trial Examining the Dose-Response Effects of Nut Consumption on Mental Health in Young Adults. Healthcare (Basel). 2026 Feb 9;14(4):435. doi: 10.3390/healthcare14040435.

  PMID: 41753948 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being; Depression; Sleep Initiation and Maintenance Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Arthur Eumann Mesas, PhD

  Health and Social Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur Eumann Mesas, PdD

CONTACT

+34 926053716; arthur.emesas@uclm.es

Miriam Garrido-Miguel, PhD

CONTACT

+34 926054003; miriam.garrido@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The allocation sequence will be concealed from the research team until the allocation time. Participants will be informed of their group assignment upon completion of the randomization process.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 6-month, randomized, single-blinded, three-arm, dose-response, clinical trial

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 18, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: These data will remain accessible for a minimum period of five years.
• Access Criteria: All data will be securely stored under the responsibility of the project's Principal Investigator, Arthur Eumann Mesas, ensuring compliance with institutional and ethical data protection requirements.

Locations

ES (1)