Improving ADHD Symptoms and Quality of Life Through Diet

ConditionADHD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity College Cork

About this trial

The goal of this randomised controlled trial is to evaluate whether a specific dietary intervention can reduce core symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults aged 18 to 50 years. The study also aims to understand how changes in diet may influence quality of life, neurocognitive function, and gut-brain signaling through the microbiota.

The main questions it aims to answer are:

1. Does a high-fiber, fermented food-based diet reduce ADHD core symptoms over a 12-week period, as measured by the Conners' Adult ADHD Rating Scale (CAARS)? 2. Does the diet improve neurocognitive function, mood, food reward, individual goals, and other quality-of-life outcomes? 3. How does the diet affect gut microbial composition, inflammation, and stress-related biomarkers? 4. Is the diet well-accepted and feasible to follow?

Researchers will compare a combination intervention diet (high in fiber and fermented foods) to a control diet based on general healthy eating guidelines to assess differences in symptom improvement and biological outcomes.

Participants will:

1. Complete six study visits over a 24-week period (screening, baseline, weeks 4, 8, 12, and optional follow-up at week 24). 2. Be randomly assigned to one of two dietary groups after baseline assessments. 3. Provide stool, saliva, urine, and blood samples at multiple timepoints. 4. Undergo cognitive testing and EEG recording to assess brain function. 5. Wear a wristband to track sleep and activity patterns. 6. Use a nutrition app to log dietary intake and receive weekly dietary support. 7. Complete validated questionnaires on ADHD symptoms, mood, eating behavior, gastrointestinal health, sleep, and lifestyle factors. Feasibility and acceptability of following the diet will also be self-reported.

This study includes both adults diagnosed with ADHD and matched controls without a psychiatric condition to better understand the mechanisms and potential differential responses to dietary intervention.

Eligibility criteria

Qualifiers

Be able to give written informed consent

Should be stable for 4 weeks on psychopharmacological medication or without medication

Should have an established diagnosis of ADHD or ADD as the main mental disorder diagnosis. This will be validated by the ADHD diagnostic criteria after DSM-5, with the DIVA interview.

Aged 18-50 years

Disqualifiers

Current severe depressive (PHQ-9>15), manic or psychotic episode, acute suicidality or suicide attempt in the past 3 months, current severe alcohol and illegal drug dependency as determined by the MINI Psychiatric Interview or clinical diagnosis.

Pregnant, breastfeeding, or planning to be pregnant.

Habitual fibre intake exceeding 25g/day.

Allergy to intervention foods.

Trial design

Treatments tested in this trial

  • Combined diet

Treatment groups

200 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University College Cork

Lead sponsor

APC Microbiome Ireland, UCC

Collaborator