Impact of Nut Consumption on Mental Health in Young Adults (NUTS4BRAIN-RCT)

University of Castilla-La Mancha

Status: Enrolling

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

Treatments: Dietary Supplement: mixed nuts. Group A; Other: control group; Dietary Supplement: mixed nuts. Group B

Study type: Interventional

Funder types: Other

Identifiers

NCT07292610

SBPLY/23/180225/000177 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 3 patient groups

Control Group

Active Comparator group

Description:

Usual dietary habits.

Treatment:

Other: control group

Intervention Group A

Experimental group

Description:

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

Treatment:

Dietary Supplement: mixed nuts. Group A

Intervention Group B

Experimental group

Description:

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

Treatment:

Dietary Supplement: mixed nuts. Group B