Impact of the MIND Diet on ADHD Symptoms in Untreated Children

Sponsor
American University of Beirut Medical Center
Study ID
NCT07686458
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • MIND Diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) Dietary Intervention — OTHER
    Participants in the intervention arm will follow the MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) diet for a 12-week period. The intervention consists of a structured dietary program designed to increase the intake of foods associated with brain health, including green leafy vegetables, other vegetables, berries, nuts, whole grains, legumes, fish, poultry, and olive oil, while reducing the consumption of foods high in saturated fats and added sugars such as fried foods, red meats, butter, pastries, and processed foods. Caregivers will receive individualized nutritional counseling from a registered nutritionist at the start of the study, including detailed guidance on recommended food groups, portion sizes, and strategies for incorporating the diet into family meals. Educational materials such as meal plans, recipes, and food lists will be provided to facilitate adherence. To monitor and reinforce compliance, participants will complete periodic dietary recalls and

Study Details

This study, titled "The Effect of the MIND Diet on ADHD Symptom Severity in Children with ADHD Not on Pharmacotherapy: A Randomized Controlled Trial in Lebanon," aims to evaluate whether a structured dietary intervention can improve behavioral and cognitive outcomes in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). ADHD is one of the most common neurodevelopmental disorders in childhood and is characterized by persistent patterns of inattention, hyperactivity, and impulsivity that interfere with academic performance, social functioning, and daily activities. Although pharmacological treatments such as stimulant medications are considered the standard approach for ADHD management, many families either prefer to delay medication use or avoid it altogether due to concerns about side effects, stigma, or personal preferences. Consequently, there is growing interest in complementary and non-pharmacological approaches that may help manage symptoms and improve quality of life for children with ADHD. The present study investigates the potential benefits of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay), a dietary pattern that combines elements of the Mediterranean diet and the DASH diet. The MIND diet emphasizes foods associated with brain health and anti-inflammatory properties, including green leafy vegetables, berries, nuts, whole grains, olive oil, fish, legumes, and poultry, while limiting foods that may negatively affect cognitive function such as processed foods, fried foods, red meats, and sweets. Although the MIND diet has demonstrated neuroprotective effects in adults, particularly in relation to cognitive decline and neurodegenerative diseases, its potential role in managing ADHD symptoms in children remains largely unexplored. This study therefore seeks to address an important gap in the literature by evaluating whether dietary patterns that support brain health can influence behavioral and cognitive outcomes in pediatric ADHD. The research employs a two-arm randomized controlled trial (RCT) design and will recruit a total of 158 children aged 6-12 years who have been diagnosed with ADHD and are not currently receiving pharmacological treatment. Participants will be randomly assigned in a 1:1 ratio to either the intervention group, which will follow the MIND diet, or a control group, which will receive general dietary advice based on standard nutritional recommendations. The intervention will last for 12 weeks, with data collected at baseline and at monthly follow-up visits throughout the study. During the intervention, families in the MIND diet group will receive education sessions from a nutritionist, educational materials including recipes and meal plans, and biweekly phone calls to support adherence and address any difficulties in implementing the diet. The primary outcome of the study is the change in ADHD symptom severity, measured using the ADHD Rating Scale-IV (ADHD-RS-IV), a validated instrument completed by both parents and teachers. Assessing symptoms from both home and school settings provides a comprehensive evaluation of behavioral changes over time. Secondary outcomes include measures of executive functioning, assessed using the Behavior Rating Inventory of Executive Function (BRIEF) and selected tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB). These tools allow the study to evaluate both subjective and objective aspects of cognitive functioning, including working memory, planning, and inhibitory control. Additional outcomes include assessments of quality of life, physical health, and dietary adherence. Quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL), while broader emotional and behavioral functioning will be evaluated using the Strengths and Difficulties Questionnaire (SDQ). Anthropometric measurements such as height, weight, and body mass index (BMI) will be recorded throughout the study to assess potential physical health changes associated with the dietary intervention. Dietary adherence will be monitored using repeated dietary records and a sociodemographic and barriers questionnaire designed to identify factors influencing families' ability to follow the diet. These analyses will also explore predictors of adherence, including caregiver involvement, socioeconomic status, and the child's age. The study is particularly relevant within the Lebanese and broader Middle East and North Africa (MENA) context, where stigma surrounding mental health and concerns about medication often contribute to underutilization of mental health services. By examining a culturally acceptable and accessible intervention based on widely available foods, the study aims to provide families with an alternative or complementary strategy for ADHD management. Overall, this research seeks to determine whether adherence to the MIND diet can reduce ADHD symptom severity, improve executive function

Key Dates

First listed
Jul 7, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
158 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MIND Diet Intervention to Assess Its Effect on ADHD Symptom Severity in Children
    Participants randomized to the intervention arm will follow the MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) diet for a period of 12 weeks. The MIND diet emphasizes increased consumption of brain-healthy foods such as green leafy vegetables, other vegetables, berries, nuts, whole grains, legumes, fish, poultry, and olive oil, while limiting foods associated with poorer cognitive outcomes including fried foods, processed foods, red meats, butter, and sweets. Caregivers and children will receive structured nutritional counseling from a registered nutritionist, along with educational materials including meal plans, recipes, and food lists to facilitate implementation of the diet at home. Participants will attend scheduled follow-up visits and receive biweekly phone calls from the research team to support adherence, monitor dietary intake, and address challenges encountered during the intervention period.
  • No Intervention: General Dietary Recommendations Control Group
    Participants randomized to the control arm will receive general dietary guidance based on standard healthy eating recommendations for children but will not be instructed to follow the MIND diet. Caregivers will receive brief advice encouraging a balanced diet that includes fruits, vegetables, whole grains, lean proteins, and dairy products, without specific meal plans or structured dietary counseling. Participants in this group will continue their usual eating habits throughout the 12-week study period. They will attend the same scheduled study visits as the intervention group and complete identical assessments, including questionnaires evaluating ADHD symptoms, executive functioning, and quality of life. Anthropometric measurements such as height, weight, and body mass index will also be recorded. This group serves as the comparison condition to evaluate the impact of the MIND diet intervention.

Primary Outcome Measure

ADHD Symptom Severity [ Time Frame: ADHD symptom severity will be assessed at week 4, week8 snd at the end of the study (week 12) ]

Central Contacts

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