Impact of the MIND Diet on ADHD Symptoms in Untreated Children

Background and Rationale Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most prevalent neurodevelopmental disorders affecting children worldwide. It is characterized by persistent patterns of inattention, hyperactivity, and impulsivity that interfere with development and functioning across multiple settings, including home, school, and social environments. Children with ADHD frequently experience difficulties in academic performance, behavioral regulation, executive functioning, and interpersonal relationships. In addition to these immediate challenges, untreated ADHD may lead to long-term consequences including poor educational attainment, social difficulties, substance use, and psychiatric comorbidities in adolescence and adulthood.

Standard treatment for ADHD typically involves pharmacological therapy, most commonly stimulant medications, combined with behavioral and psychosocial interventions. Pharmacotherapy has been consistently shown to reduce core ADHD symptoms and improve functioning in many patients. Despite its effectiveness, medication treatment is not always acceptable or accessible for all families. Some parents express concerns about potential side effects, long-term medication use, or the stigma associated with psychiatric treatment. In certain cultural contexts, including the Middle East and North Africa region, stigma related to mental health conditions and psychiatric medication can further contribute to delays in treatment initiation.

As a result, there has been increasing interest in non-pharmacological approaches that may complement or serve as alternatives to traditional ADHD treatments. Lifestyle factors such as diet, sleep, and physical activity have emerged as potential contributors to cognitive and behavioral functioning in children. In particular, nutrition has gained attention as a potentially modifiable factor influencing neurodevelopment and mental health outcomes.

Dietary patterns can influence brain health through several biological pathways, including inflammation, oxidative stress, and neurotransmitter synthesis. Diets rich in whole foods, antioxidants, and unsaturated fats have been associated with improved cognitive functioning and mental well-being. Conversely, diets high in processed foods, saturated fats, and refined sugars have been linked to poorer cognitive outcomes and increased behavioral problems in children.

The MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) is a dietary pattern specifically designed to promote brain health and reduce cognitive decline. It combines elements from two well-established dietary patterns: the Mediterranean diet and the Dietary Approaches to Stop Hypertension (DASH) diet. The MIND diet emphasizes the consumption of foods associated with neuroprotection and anti-inflammatory effects, including green leafy vegetables, berries, nuts, whole grains, olive oil, legumes, fish, and poultry. At the same time, it encourages limiting foods that may negatively affect cognitive health, such as fried foods, red meats, processed foods, butter, and sweets.

Although the MIND diet has demonstrated beneficial effects on cognitive aging and neurodegenerative diseases in adult populations, its potential role in pediatric neurodevelopmental disorders has not yet been thoroughly investigated. ADHD has been associated with neurobiological mechanisms that involve inflammation, oxidative stress, and altered neurotransmitter pathways. Because the MIND diet contains foods rich in antioxidants, polyphenols, omega-3 fatty acids, and other nutrients that support brain health, it may represent a promising intervention for improving ADHD symptoms and cognitive functioning in children.

Furthermore, the dietary components emphasized in the MIND diet are largely consistent with traditional Mediterranean dietary patterns commonly found in Lebanon and neighboring countries. This cultural compatibility may facilitate the implementation and sustainability of the intervention among families in the region.

The present study therefore seeks to evaluate whether adherence to the MIND diet can reduce ADHD symptom severity and improve cognitive and behavioral functioning in children diagnosed with ADHD who are not currently receiving pharmacological treatment.

Study Objectives Primary Objective The primary objective of this study is to determine whether adherence to the MIND diet leads to a reduction in ADHD symptom severity among children diagnosed with ADHD who are not currently receiving pharmacological treatment.

Secondary Objectives

Several secondary objectives will also be investigated:

* To evaluate the impact of the MIND diet on executive functioning in children with ADHD. * To assess changes in cognitive performance using objective neuropsychological testing. * To examine whether the dietary intervention improves quality of life and psychosocial functioning. * To assess whether the intervention influences physical health indicators such as body mass index. * To evaluate adherence to the dietary intervention and identify barriers to maintaining the diet. * To explore sociodemographic and environmental factors associated with successful adherence to the MIND diet.

Study Hypothesis The study hypothesizes that children who follow the MIND diet will demonstrate a greater reduction in ADHD symptoms compared with children receiving general dietary advice. Additionally, the intervention group is expected to show improvements in executive functioning, cognitive performance, and overall quality of life.

Study Design This research will be conducted as a randomized controlled trial (RCT) with two parallel arms.

Participants will be randomly assigned to one of two groups:

Intervention Group: Participants will follow the MIND diet for the duration of the study.

Control Group: Participants will receive general dietary guidance based on standard healthy eating recommendations.

Randomization will be performed using a computer-generated randomization sequence to ensure unbiased allocation of participants to each study arm. Allocation will occur in a 1:1 ratio, ensuring equal distribution of participants across the intervention and control groups.

The intervention will last 12 weeks (three months). Participants will undergo assessments at baseline and at regular intervals throughout the intervention period in order to evaluate changes in ADHD symptoms and other outcomes over time.

Study Population Target Population The target population for this study consists of children aged 6 to 12 years who have been diagnosed with ADHD according to the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

Sample Size A total of 158 participants will be recruited for the study. This sample size was determined based on statistical power calculations designed to detect a clinically meaningful reduction in ADHD symptom severity between the intervention and control groups.

Participants will be evenly divided between the two study arms, with approximately 79 children in each group.

Recruitment Participants will be recruited primarily from the Department of Psychiatry at the American University of Beirut Medical Center (AUBMC). Children who receive a clinical diagnosis of ADHD during routine psychiatric evaluation may be invited to participate in the study if they meet eligibility criteria.

Recruitment is expected to occur over a period of approximately two years. Inclusion and Exclusion Criteria Inclusion Criteria

Participants must meet the following criteria:

* Children aged between 6 and 12 years * Diagnosis of ADHD based on DSM-5 diagnostic criteria * Not currently receiving pharmacological treatment for ADHD * Willingness of both the child and caregiver to participate in the study * Caregivers willing to follow the dietary intervention and attend study visits Exclusion Criteria

Children may be excluded if they:

* Have medical conditions requiring specialized diets * Have severe developmental or neurological disorders that may interfere with study participation * Are currently receiving stimulant or other pharmacological treatment for ADHD Intervention Participants in the intervention group will follow the MIND diet for the duration of the study.

The MIND diet encourages regular consumption of foods associated with brain health, including:

* Green leafy vegetables * Other vegetables * Berries * Nuts * Whole grains * Legumes * Fish * Poultry * Olive oil

The diet also recommends limiting the consumption of foods that may negatively affect cognitive functioning, including:

* Fried foods * Processed foods * Red meats * Butter and margarine * Sweets and sugary foods The dietary intervention will be delivered by a registered nutritionist who is part of the research team.

At the beginning of the study, caregivers will attend an educational session where they will receive detailed instructions about the dietary guidelines, recommended food portions, and practical strategies for implementing the diet in daily meals.

Participants will receive educational materials that include:

* Meal planning guides * Recipes based on the MIND diet * Lists of recommended and restricted foods * Practical tips for grocery shopping and meal preparation To support adherence, families in the intervention group will receive biweekly follow-up phone calls from the research team. These calls will help address potential challenges, reinforce dietary recommendations, and monitor compliance.

Participants in the control group will receive general advice regarding healthy eating but will not receive specific instructions about the MIND diet.

Outcome Measures Primary Outcome The primary outcome of the study is ADHD symptom severity. Symptoms will be assessed using the ADHD Rating Scale-IV, an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 diagnostic criteria. Each item is rated on a four-point scale ranging from "never" to "very often." Both parents and teachers will complete the questionnaire to provide information about symptoms across different environments.

Secondary Outcomes Executive Function Executive functioning will be evaluated using the Behavior Rating Inventory of Executive Function (BRIEF), which assesses domains such as inhibition, working memory, cognitive flexibility, and planning.

Cognitive Performance Objective neuropsychological functioning will be assessed using tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Quality of Life Children's quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL).

• Executive Function [Срок оценки: Will be assessed AT baseline, week 4, week 8, and week 12]