Impact of Nut Consumption on Mental Health in Young Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-24
SponsorUniversity of Castilla-La Mancha
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Allergies: Known nut allergy.
Self-reported cardiovascular, metabolic, gastrointestinal or mental health disorder.
Trial design
Design model
Parallel
Treatments tested in this trial
mixed nuts. Group A
Dietary supplementParticipants 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 B
Dietary supplementParticipants 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 group
Other interventionParticipants will be instructed to maintain their regular diet without any specific dietary instructions or intervention.
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Intervention Group AExperimental treatment 1 intervention
Group C: Intervention Group BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
"Day 0", "Month 3", "Month 6", "Month 12"2
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
Time frame
"Day 0", "Month 3", "Month 6", "Month 12"3
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.
Time frame
"Day 0", "Month 3", "Month 6", "Month 12"4
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.
Time frame
"Day 0", "Month 3", "Month 6", "Month 12"Secondary outcomes
1
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.
Time frame
"Day 0", "Month 3", "Month 6", "Month 12"2
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.
Time frame
"Day 0", "Month 3", "Month 6", "Month 12"3
Inflammatory biomarkers
Changes in blood inflammatory markers (e.g. hs-CRP) to examine underlying mechanisms
Time frame
"Day 0", "Month 3", "Month 6", "Month 12"4
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
Time frame
"Day 0", "Month 3", "Month 6", "Month 12"Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Castilla-La Mancha
Lead sponsor
European Union
Collaborator
Source ClinicalTrials.gov