Depression DisorderNUTS4BRAIN-RCTNCT07292610
Impact of Nut Consumption on Mental Health in Young Adults
A study testing mixed nuts. Group A and mixed nuts. Group B in people with Depression Disorder and Anxiety, run by University of Castilla-La Mancha at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Disorder, Anxiety, Mental Health
- What is being tested?
- mixed nuts. Group A and mixed nuts. Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSpain
- Study dates
- 24 Nov 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Who cannot join
- Allergies: Known nut allergy.
- Self-reported cardiovascular, metabolic, gastrointestinal or mental health disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Health and Social Research Center. University of Castilla-La Mancha
Cuenca, Cuenca, 16071
Arthur Eumann Mesas, PhD, +34 926053716, arthur.emesas@uclm.es
Estela Jiménez López, PhD, +34 926053778, estela.jimenezlopez@uclm.es
About this study
Official title: Impact of Nut Consumption on Mental Health in Young Adults: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Depression Disorder, Anxiety, Mental Health, Stress, Cognition, BDNF
- Being tested
- mixed nuts. Group A, mixed nuts. Group B, control group
- 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
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed nuts. Group ADietary 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
mixed nuts. Group BDietary 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
control groupOther
Participants will be instructed to maintain their regular diet without any specific dietary instructions or intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Usual dietary habits. Receives: Other: control group |
| Intervention Group A | Experimental | Nut consumption (walnuts, almonds, pistachios, and hazelnuts mix). Receives: Dietary Supplement: mixed nuts. Group A |
| Intervention Group B | Experimental | Nut consumption (walnuts, almonds, pistachios, and hazelnuts mix). Receives: Dietary Supplement: mixed nuts. Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "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
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Secondary outcomes (23)
Sleep quality
Changes in quality of sleep assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 individual self-rated questions (and 5 optional questions for a roommate/bed partner) that are grouped into seven component scores. Each of the seven components is scored on a scale of 0 to 3, where 0 indicates no difficulty and 3 indicates severe difficulty. The scores of these components are summed to produce a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Health-related quality of life (HRQL)
Changes in health-related quality of life assessed with the SF12 questionnaire. It consists of 12 questions that cover the same eight health domains as the longer SF-36: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health.
The 12 items are used to create two main summary measures through a complex, norm-based scoring algorithm:
Physical Component Summary (PCS): A single score representing physical health status.
Mental Component Summary (MCS): A single score representing mental and emotional health status.
Interpretation of Scores:
Scores for both PCS and MCS typically range from 0 to 100, where higher scores indicate better health and functioning.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Inflammatory biomarkers
Changes in blood inflammatory markers (e.g. hs-CRP) to examine underlying mechanisms
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Concentration of vitamins and minerals
Changes in blood concentration of specific vitamins and minerals (e.g., vitamins B9, B12, D, iron, and magnesium) to examine underlying mechanisms
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Body image
Changes in body image perception using The Standard Figural Stimuli (SFS). Measurement Purpose:
Perceived Body Image: The figure the individual selects as most representative of their current body size.
Ideal Body Image: The figure the individual would like to have. Body Dissatisfaction: The discrepancy between the perceived image and the ideal image. A larger difference indicates greater body dissatisfaction.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Screen time
Screen time will be assessed using an ad hoc questionnaire that records the number of hours of leisure time participants spend watching television, using a mobile phone, using a computer for work-related purposes, or engaging with other electronic devices, both on weekdays and during weekends.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Social media addiction
Changes in social media addiction through Social Network Addiction Questionnaire, 6-item version (ARS-6). The scale typically consists of 6 items, with one item representing each of the six components of addiction.
Response Scale: Responses are typically given on a 5-point Likert scale (e.g., from 1 = Not at all to 5 = Always).
Scoring: Item responses are summed to obtain a total score, ranging from 6 to 30. Higher scores indicate a greater risk or severity of social media addiction.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Sociodemographic
Sociodemographic information such as age, sex, date of birth, country of origin, marital status, housing type, medication use, and family history of mental or cardiovascular disorders.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Drugs consumption
Changes in drugs consumption assessed with the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). The ASSIST generates substance-specific risk scores that categorize use into low, moderate, or high-risk categories. Higher scores indicate a greater risk of substance-related health and social problems, guiding the type of intervention needed (e.g., brief intervention or referral to specialist treatment).
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Adherence to the Mediterranean Diet
Changes in adherence to the mediterranean diet assessed with the MEDAS questionnaire.
Scoring:
Each item is scored with 1 point if the criteria for adherence to the Mediterranean diet are met, and 0 points if they are not.
The total score ranges from 0 to 14 points. Higher scores indicate greater adherence to the Mediterranean diet. A common cut-off point of ≥9 is often used to define good adherence to the diet.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Resilience
Changes in resilience assessed with the Connor-Davidson Resilience Scale (CD-RISC 10). Each item is rated on a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all the time). The total score is calculated by summing the values of all 10 items. Total scores range from 0 to 40. Higher scores on the CD-RISC 10 indicate greater resilience and a better ability to cope with adversity and bounce back from difficult experiences.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Risk of eating disorders
The SCOFF questionnaire (an acronym derived from the initials of its English questions: Sick, Control, One stone, Fat, Food) is a brief and simple, five-question screening tool designed to detect the possible presence of eating disorders (EDs), such as anorexia nervosa and bulimia nervosa. The total score can range from 0 to 5. A score of two or more points is considered a positive screening result and suggests a suspicion of an ED that requires a detailed formal clinical assessment.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Weight
Weight in kilograms will be assessed twice using a calibrated digital scale (Scale Seca® 861) with participants barefoot and in light weight clothing.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Height
Height will be measured twice with a stadiometer (Wall stadiometer Seca® 222), with participants standing upright, barefoot, and with the sagittal midline aligned to the wall.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Body Mass Index (BMI)
BMI will be calculated as weight divided by height squared (kg/m2).
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Body fat percentage
Body fat percentage will be assessed twice using the bioimpedance analysis system under standardized conditions (morning, fasting, post-void, after 15 minutes rest, barefoot, with controlled temperature and humidity).
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Blood pressure
Blood pressure will be measured using an automated device (OMRON® M5-I (Omron Healthcare UK Ltd.)). Systolic and diastolic blood pressure will be assessed twice, with a 5-minute interval between measurements. Participants will be seated in a quiet environment, with the right arm semi-flexed at heart level.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Muscular strenght
Measured through handgrip strength using a calibrated dynamometer (Digital dynamometer TKK 5401 Grip-D (Takey®, Tokyo, Japan), and standing long jump for lower body strength. Handgrip: Kilograms (kg). Horizontal jump: Centimeters (cm).
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Phisical activity
Changes in phisical activity assessed with the The International Physical Activity Questionnaire (IPAQ). The data collected with the IPAQ can be reported as a continuous measure (estimation of total energy expenditure in MET-minutes per week) or categorically (classifying individuals into low, moderate, or high physical activity levels):
Continuous Score: Total energy expenditure is calculated using specific formulas that assign MET (metabolic equivalent) values to each activity type (walking=3.3 METs, moderate=4.0 METs, vigorous=8.0 METs).
Categorical Score: Participants are classified into three levels of physical activity based on predefined criteria related to the duration, frequency, and intensity of activities.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Lipid profile
Changes in blood lipid profile (Cholesterol (Total, HDL-c, LDL-c), triglycerides)) to examine underlying mechanisms.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Glucose levels
Changes in blood glucose levels to examine underlying mechanisms.
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Hemoglobin A1c (HbA1c)
Changes in blood HbA1c levels to examine underlying mechanisms.
Measured: Day 0", "Month 3", "Month 6", "Month 12"
Adherence verification
Adherence to nut consumption intervention measured by blood levels of vitamin E
Measured: "Day 0", "Month 3", "Month 6", "Month 12"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start24 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 6-month, randomized, single-blinded, three-arm, dose-response, clinical trial
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Arthur Eumann Mesas, PhD, Principal investigator, Health and Social Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292610
- Sponsor's protocol ID
- SBPLY/23/180225/000177
- Other IDs
- SBPLY/23/180225/000177
- Acronym
- NUTS4BRAIN-RCT
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data generated in this project will be publicly shared through Zenodo an open-access repository compliant with FAIR (Findable, Accessible, Interoperable, and Reusable) principles.
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, 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.
PubMed 41753948
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nut Consumption on Mental Health in Young Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07292610
- Acronym / sponsor ID
- NUTS4BRAIN-RCT / SBPLY/23/180225/000177
- Conditions
- Depression Disorder, Anxiety, Mental Health, Stress, Cognition, BDNF
- Keywords
- RCT, Dietary Intervention, Nut consumption, young adults, Randomized controlled trial, Mental Health, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A 6-month, randomized, single-blinded, three-arm, dose-response, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: control groupUsual dietary habits. |
| Intervention Group A | Experimental | Dietary Supplement: mixed nuts. Group ANut consumption (walnuts, almonds, pistachios, and hazelnuts mix). |
| Intervention Group B | Experimental | Dietary Supplement: mixed nuts. Group BNut consumption (walnuts, almonds, pistachios, and hazelnuts mix). |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (2 listed)
- Allergies: Known nut allergy.
- Self-reported cardiovascular, metabolic, gastrointestinal or mental health disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mixed nuts. Group AParticipants 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 | Dietary supplement | Intervention Group A |
| mixed nuts. Group BParticipants 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 | Dietary supplement | Intervention Group B |
| control groupParticipants will be instructed to maintain their regular diet without any specific dietary instructions or intervention. | Other | Control Group |
Primary outcome
Depression
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
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.
Anxiety
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
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
Stress
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
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.
Episodic memory
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
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.
Working memory
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
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.
Cognitive flexibility
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
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.
Processing speed
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
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.
Inhibitory control and attention
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
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.
Brain Derived Neurotrophic Factor
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Changes in blood concentration of brain-derived neurotrophic factor (BDNF), a biochemical mediator of brain functioning
23 secondary outcomes
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"
Weight
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Height
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Body Mass Index (BMI)
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Body fat percentage
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Blood pressure
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Muscular strenght
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Phisical activity
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Lipid profile
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Glucose levels
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Hemoglobin A1c (HbA1c)
Time frame: Day 0", "Month 3", "Month 6", "Month 12"
Adherence verification
Time frame: "Day 0", "Month 3", "Month 6", "Month 12"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 41753948Mesas 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.
- Individual participant dataSharing planned: Yes. The data generated in this project will be publicly shared through Zenodo an open-access repository compliant with FAIR (Findable, Accessible, Interoperable, and Reusable) principles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arthur Eumann Mesas, PhD principal investigator
Health and Social Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mixed nuts. Group A and mixed nuts. Group B in people with Depression Disorder and Anxiety, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur Eumann Mesas, PdD (+34 926053716, arthur.emesas@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: "Day 0", "Month 3", "Month 6", "Month 12"). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07292610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.