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Impact of Nut Consumption on Mental Health in Young Adults

NCT ID: NCT07292610

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2027-04-30

Brief Summary

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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

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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

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Depression Disorder Anxiety Mental Health Stress Cognition BDNF General Wellbeing

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A 6-month, randomized, single-blinded, three-arm, dose-response, clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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Control Group

Usual dietary habits.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type OTHER

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

Intervention Group A

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

Group Type EXPERIMENTAL

mixed nuts. Group A

Intervention Type 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 B

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

Group Type EXPERIMENTAL

mixed nuts. Group B

Intervention Type 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

Interventions

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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. 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 Type 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 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 Type DIETARY_SUPPLEMENT

control group

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Union

OTHER

Sponsor Role collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur Eumann Mesas, PhD

Role: PRINCIPAL_INVESTIGATOR

Health and Social Research Center

Locations

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

Cuenca, Cuenca, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Arthur Eumann Mesas, PdD

Role: CONTACT

Phone: +34 926053716

Email: [email protected]

Miriam Garrido-Miguel, PhD

Role: CONTACT

Phone: +34 926054003

Email: [email protected]

Facility Contacts

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Arthur Eumann Mesas, PhD

Role: primary

Estela Jiménez López, PhD

Role: backup

Other Identifiers

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SBPLY/23/180225/000177

Identifier Type: -

Identifier Source: org_study_id

SBPLY/23/180225/000177

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id