Impact of Nut Consumption on Mental Health in Young Adults: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
排除标准
- •Allergies: Known nut allergy.
- •Self-reported cardiovascular, metabolic, gastrointestinal or mental health disorder.
结局指标
主要结局
Depression
时间窗: "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
时间窗: "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
时间窗: "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
时间窗: "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
时间窗: "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
时间窗: "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
时间窗: "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
时间窗: "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
时间窗: "Day 0", "Month 3", "Month 6", "Month 12"
Changes in blood concentration of brain-derived neurotrophic factor (BDNF), a biochemical mediator of brain functioning
次要结局
- 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")
- Screen time("Day 0", "Month 3", "Month 6", "Month 12")
- Social media addiction("Day 0", "Month 3", "Month 6", "Month 12")
- Sociodemographic("Day 0", "Month 3", "Month 6", "Month 12")
- Drugs consumption("Day 0", "Month 3", "Month 6", "Month 12")
- Adherence to the Mediterranean Diet("Day 0", "Month 3", "Month 6", "Month 12")
- Resilience("Day 0", "Month 3", "Month 6", "Month 12")
- Risk of eating disorders("Day 0", "Month 3", "Month 6", "Month 12")
- Weight("Day 0", "Month 3", "Month 6", "Month 12")
- Height("Day 0", "Month 3", "Month 6", "Month 12")
- Body Mass Index (BMI)("Day 0", "Month 3", "Month 6", "Month 12")
- Body fat percentage("Day 0", "Month 3", "Month 6", "Month 12")
- Blood pressure("Day 0", "Month 3", "Month 6", "Month 12")
- Muscular strenght("Day 0", "Month 3", "Month 6", "Month 12")
- Phisical activity("Day 0", "Month 3", "Month 6", "Month 12")
- Lipid profile("Day 0", "Month 3", "Month 6", "Month 12")
- Glucose levels("Day 0", "Month 3", "Month 6", "Month 12")
- Hemoglobin A1c (HbA1c)(Day 0", "Month 3", "Month 6", "Month 12")
- Adherence verification("Day 0", "Month 3", "Month 6", "Month 12")