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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Combined diet
Other interventionParticipants will receive dietary education to increase their fibre intake to 25-30g/day and include 3 to 4 portions of fermented foods to their normal diet.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: No ADHD/Combined DietExperimental treatment 1 intervention
Group B: No ADHD/Control dietNo intervention 0 interventions
Group C: ADHD/Control dietNo intervention 0 interventions
Group D: ADHD/Combined dietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in ADHD core symptoms
Change in ADHD core symptoms from baseline to the end of diet (12 weeks) measured by Conner's ADHD rating scale total score (CAARS). The CAARS Total ADHD Symptoms score ranges approximately from 0 to 100, with higher scores indicating greater ADHD symptom severity (worse outcome).
Time frame
From baseline to 12 weeksSecondary outcomes
1
Change in neurocognitive function and mood, and other secondary domains
Secondary objectives include whether the combined intervention changes neurocognitive function, mood, quality of life, individual goals attainment, changes in sleep, eating behaviour, gastrointestinal symptoms, gut microbial profile, and gut-brain signalling pathways, including immune and inflammatory markers, cortisol, and a broad range of proteins and metabolites. Additionally, changes in sub-scales of Conner's ADHD Rating Scale (CAARS) will be assessed as secondary outcome. The sub-scales are: Inattention/Executive Dysfunction (0-30), Hyperactivity (0-13), Impulsivity (0-13), Emotional Dysregulation (0-9), Negative Self-Concept (0-7), with higher scores indicating greater symptom severity (worse outcome).
Time frame
From baseline to 12 weeksOther outcomes
1
Tertiary Outcomes
Tertiary outcomes include assessment of the acceptability and feasibility of the combined dietary intervention, validation of a questionnaire assessing the frequency of fermented food intake in adults with and without ADHD, and evaluation of the long-term effects of the intervention on study outcomes at 12 weeks post-intervention. Acceptability and feasibility will be assessed using study-specific questionnaire. For long-term effects of the intervention, the Conners' Adult ADHD Rating Scales (CAARS) Total ADHD Symptoms will be measured, ranging approximately from 0 to 100, with higher scores indicating greater ADHD symptom severity (worse outcome).
Time frame
From baseline to 12 weeks (end of dietary intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University College Cork
Lead sponsor
APC Microbiome Ireland, UCC
Collaborator
Source ClinicalTrials.gov
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