ADHDADAPTNCT07376746
Improving ADHD Symptoms and Quality of Life Through Diet
A study testing Combined diet in people with ADHD, run by University College Cork at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Combined diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
ADHD Group Inclusion Criteria:
- 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
- Fluency in English language
Control Group Inclusion Criteria
- Be able to give written informed consent
- Should be stable for 4 weeks on any medication for physical health or without medication
- Should not currently taking psychopharmacological medicine or discontinued psychopharmacological medicine in the past 6 months (due to relapse risk)
- Should NOT have an established diagnosis or clinical symptoms of ADHD or ADD. This will be validated using with the ASRS-6 (< 4)
- Should not have a diagnosis of ASD as indicated by self-report.
- Not have current, or in the past 2 years, symptoms or diagnosis of a depressive disorder, bipolar spectrum disorder, OCD, PTSD, generalised anxiety disorder, severe alcohol or illegal drug dependency, psychotic disorder, anorexia nervosa, and bulimia nervosa
- Not have current symptoms or diagnosis of a panic disorder or social anxiety disorder that is not currently being treated by a psychotherapist or other mental health care professional
- Aged 18-50 years
- Fluency in English language
ADHD and Control Group Exclusion criteria:
- 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.
- Allergy to local anaesthesia (only if opting for the skin punch).
- Taking anticoagulant medication or have coagulation disorder like haemophilia (only if opting for the skin punch).
- Have a BMI below 18.5 kg/m2.
- Current diagnosis or symptoms of anorexia nervosa or bulimia nervosa, as determined by clinical diagnosis or on the MINI.
- Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic) or any condition which contraindicates, in the investigator's judgement, entry to the study.
- Taking antibiotics in the past month (washout period of 1 month is required).
- Taking medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include anti-inflammatory drugs, corticosteroids, laxatives, enemas, anti-coagulants, and over-the counter non-steroidal analgesics. Participants should have a wash-out period of one month.
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
- Participants receiving treatment involving experimental drugs. Washout period of one month is required.
- Current prebiotic or probiotic supplement use (a wash-out period of 4 weeks after cessation will allow entry to the study).
- Previous participation in the Diet Study (APC150)
- Uncorrected vision.
- A history of any other condition affecting cognitive function (besides ADHD or ASD for ADHD group participants).
The specific exclusion criteria for electroencephalography (EEG) recording for both the ADHD and Control groups are as follows:
- Left-handedness,
- Non-removable medical devices such as pacemakers, hearing aids, cochlear implants, or deep brain stimulators,
- Hairstyles that prevent access to the scalp, and
- Skin conditions on the scalp.
Participants who meet these exclusion criteria for the EEG portion of the study will still be included in the overall study but will not undergo EEG recording and will instead complete neurocognitive tasks outside of EEG recording.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site
APC Microbiome Ireland
Cork, Cork, T12 YT20
Lorraine Draper, +353 21 4901772, l.drapes@ucc.ie
Gerard Clarke
About this study
Official title: Improving ADHD Core Symptoms and Individual Quality of Life With Dietary APproaches Through Microbiota-Gut-Brain Signalling
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:
Read more
- 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)?
- Does the diet improve neurocognitive function, mood, food reward, individual goals, and other quality-of-life outcomes?
- How does the diet affect gut microbial composition, inflammation, and stress-related biomarkers?
- 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:
- Complete six study visits over a 24-week period (screening, baseline, weeks 4, 8, 12, and optional follow-up at week 24).
- Be randomly assigned to one of two dietary groups after baseline assessments.
- Provide stool, saliva, urine, and blood samples at multiple timepoints.
- Undergo cognitive testing and EEG recording to assess brain function.
- Wear a wristband to track sleep and activity patterns.
- Use a nutrition app to log dietary intake and receive weekly dietary support.
- 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.
Read the detailed description
This is a participant-blind, observer-blind, randomized, controlled, parallel-group trial designed to evaluate the effects of a dietary intervention on core symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) and related neurocognitive and physiological parameters in adults. The study also investigates the mechanisms underlying these effects, with a focus on the microbiota-gut-brain axis.
A total of 200 participants (100 adults with a diagnosis of ADHD/ADD and 100 healthy controls) aged 18 to 50 years will be recruited and randomized to one of two dietary arms:
- A combination intervention diet rich in fiber and fermented foods.
- A control diet based on general healthy eating guidelines following the Irish Food Pyramid.
The intervention period lasts for 12 weeks, followed by a 12-week optional follow-up.
The primary objective is to assess the change in ADHD symptoms, measured using the Conners' Adult ADHD Rating Scale (CAARS), from baseline to week 12. Secondary outcomes include changes in cognition, mood, quality of life, and individual goal attainment. Tertiary outcomes include alterations in eating behavior, sleep, activity patterns, diet feasibility and acceptability, gut microbiota composition and diversity, microbial metabolites (e.g., short-chain fatty acids), systemic inflammatory markers, and stress biomarkers (cortisol).
Study Design and Procedures
Participants will complete six study visits:
Visit 1 (Screening): Consent, eligibility assessment via structured psychiatric interview (MINI and DIVA for ADHD; MINI and ASRS for controls as well as assessing other in- and exclusion criteria), baseline sociodemographic and health data, dietary logging app setup, and instructions for pre-visit biological sample collection (stool, urine, saliva).
Visit 2 (Baseline, pre-intervention): Biological sample collection, cognitive testing, EEG (resting-state, response inhibition, and food cue responsivity), anthropometry, blood pressure, and detailed questionnaires on ADHD symptoms, mood, cognition, sleep, lifestyle, and individual goal setting. Participants are randomized and receive individualized dietary advice and guidance based on their group assignment.
Visits 3 and 4 (Week 4 and Week 8): Collection of biological samples, lifestyle and symptom questionnaires, adherence reinforcement with the dietitian, and adverse event monitoring. Body weight, circumferences, and blood pressure are reassessed.
Visit 5 (Week 12, post-intervention): Full reassessment mirroring Visit 2. Participants are debriefed, compensated, and provided with post-intervention materials. Perceived allocation (control vs. intervention) and acceptability/feasibility of the diet are also evaluated.
Visit 6 (Optional follow-up at Week 24): Evaluation of sustained effects on ADHD symptoms, quality of life, adherence, and feasibility. Stool sample is collected, anthropometry is repeated, and diet is logged again.
During the intervention, participants track their diet using a smartphone app (Nutritics/Libro) and receive weekly email support. Participants also receive personalized dietary advice according to their group allocation: a minimum of 25 grams of fiber and 3 servings of fermented foods per day for those in the combined diet group; or, for those in the control diet group, adherence to the standard food pyramid (daily portions include 5-7 servings of fruits and vegetables, 3-5 servings of whole grains, 2 servings of lean protein such as meat, fish, eggs, or legumes, 3 servings of low-fat dairy, and limited intake of fats, oils, and sweets).
Biological samples (stool, saliva, urine, blood) will be collected at multiple timepoints. Stool samples will be used for microbiota profiling (16S rRNA sequencing and metagenomics) and metabolomics (e.g., short-chain fatty acids). Saliva and urine will be analyzed for stress-related hormones, metabolomics and specific metabolites of interest. Blood samples will be analyzed for inflammatory cytokines, stress-related hormones, metabolomics, and other potential biomarkers that might be emerging when the sample recruitment is finalized. A subset of participants will undergo a skin punch biopsy to generate a human-derived cell model for investigating causal cellular mechanisms in response to microbial metabolites.
Neurocognitive and neural data will be collected using EEG tasks and computerized cognitive tasks assessing impulsivity and attention.
- Conditions
- ADHD
- Being tested
- Combined diet
- Keywords
- Psychobiotic diet, ADHD, Fermented foods, Gut-Brain Axis, Dietary fibre
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined dietOther
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| No ADHD/Combined Diet | Experimental | Participants without ADHD will receive a combined diet (fermented foods and high fiber) Receives: Other: Combined diet |
| No ADHD/Control diet | No intervention | Participants without ADHD will receive dietary education based on the healthy eating guidelines provided by the Health Service Executive (HSE). |
| ADHD/Control diet | No intervention | Participants with ADHD will receive dietary education based on the healthy eating guidelines provided by the Health Service Executive (HSE). |
| ADHD/Combined diet | Experimental | Participants with ADHD will receive a combined diet (fermented foods and high fiber) Receives: Other: Combined diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to 12 weeks
Secondary 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).
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- APC Microbiome Ireland, UCC
- Responsible party
- Principal investigator, John Cryan, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376746
- Sponsor's protocol ID
- APC199
- Acronym
- ADAPT
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brysbaert M, Stevens M. Power Analysis and Effect Size in Mixed Effects Models: A Tutorial. J Cogn. 2018 Jan 12;1(1):9. doi: 10.5334/joc.10.
PubMed 31517183Faraone SV, Biederman J, Mick E. The age-dependent decline of attention deficit hyperactivity disorder: a meta-analysis of follow-up studies. Psychol Med. 2006 Feb;36(2):159-65. doi: 10.1017/S003329170500471X.
PubMed 16420712Konstanti P, Ahrens KF, Neumann RJ, Plichta MM, Schiweck C, Ruf A, Fiebach CJ, Kalisch R, Basten U, Wessa M, Tuescher O, Kollmann B, Lieb K, Arias-Vasquez A, Smidt H, Reif A, Matura S, Belzer C. Impulsivity among healthy adults is associated with diet and fecal microbiota composition. Transl Psychiatry. 2025 Aug 3;15(1):263. doi: 10.1038/s41398-025-03483-4.
PubMed 40753077Berding K, Cryan JF. Microbiota-targeted interventions for mental health. Curr Opin Psychiatry. 2022 Jan 1;35(1):3-9. doi: 10.1097/YCO.0000000000000758.
PubMed 34750307Ribera C, Sanchez-Orti JV, Clarke G, Marx W, Morkl S, Balanza-Martinez V. Probiotic, prebiotic, synbiotic and fermented food supplementation in psychiatric disorders: A systematic review of clinical trials. Neurosci Biobehav Rev. 2024 Mar;158:105561. doi: 10.1016/j.neubiorev.2024.105561. Epub 2024 Jan 26.
PubMed 38280441Bull-Larsen S, Mohajeri MH. The Potential Influence of the Bacterial Microbiome on the Development and Progression of ADHD. Nutrients. 2019 Nov 17;11(11):2805. doi: 10.3390/nu11112805.
PubMed 31744191
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving ADHD Core Symptoms and Individual Quality of Life With Dietary APproaches Through Microbiota-Gut-Brain Signalling
- ClinicalTrials.gov ID
- NCT07376746
- Acronym / sponsor ID
- ADAPT / APC199
- Conditions
- ADHD
- Keywords
- Psychobiotic diet, ADHD, Fermented foods, Gut-Brain Axis, Dietary fibre
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- APC Microbiome Ireland, UCC
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- Does the diet improve neurocognitive function, mood, food reward, individual goals, and other quality-of-life outcomes?
- How does the diet affect gut microbial composition, inflammation, and stress-related biomarkers?
- 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:
- Complete six study visits over a 24-week period (screening, baseline, weeks 4, 8, 12, and optional follow-up at week 24).
- Be randomly assigned to one of two dietary groups after baseline assessments.
- Provide stool, saliva, urine, and blood samples at multiple timepoints.
- Undergo cognitive testing and EEG recording to assess brain function.
- Wear a wristband to track sleep and activity patterns.
- Use a nutrition app to log dietary intake and receive weekly dietary support.
- 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.
Detailed description
This is a participant-blind, observer-blind, randomized, controlled, parallel-group trial designed to evaluate the effects of a dietary intervention on core symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) and related neurocognitive and physiological parameters in adults. The study also investigates the mechanisms underlying these effects, with a focus on the microbiota-gut-brain axis.
A total of 200 participants (100 adults with a diagnosis of ADHD/ADD and 100 healthy controls) aged 18 to 50 years will be recruited and randomized to one of two dietary arms:
- A combination intervention diet rich in fiber and fermented foods.
- A control diet based on general healthy eating guidelines following the Irish Food Pyramid.
The intervention period lasts for 12 weeks, followed by a 12-week optional follow-up.
The primary objective is to assess the change in ADHD symptoms, measured using the Conners' Adult ADHD Rating Scale (CAARS), from baseline to week 12. Secondary outcomes include changes in cognition, mood, quality of life, and individual goal attainment. Tertiary outcomes include alterations in eating behavior, sleep, activity patterns, diet feasibility and acceptability, gut microbiota composition and diversity, microbial metabolites (e.g., short-chain fatty acids), systemic inflammatory markers, and stress biomarkers (cortisol).
Study Design and Procedures
Participants will complete six study visits:
Visit 1 (Screening): Consent, eligibility assessment via structured psychiatric interview (MINI and DIVA for ADHD; MINI and ASRS for controls as well as assessing other in- and exclusion criteria), baseline sociodemographic and health data, dietary logging app setup, and instructions for pre-visit biological sample collection (stool, urine, saliva).
Visit 2 (Baseline, pre-intervention): Biological sample collection, cognitive testing, EEG (resting-state, response inhibition, and food cue responsivity), anthropometry, blood pressure, and detailed questionnaires on ADHD symptoms, mood, cognition, sleep, lifestyle, and individual goal setting. Participants are randomized and receive individualized dietary advice and guidance based on their group assignment.
Visits 3 and 4 (Week 4 and Week 8): Collection of biological samples, lifestyle and symptom questionnaires, adherence reinforcement with the dietitian, and adverse event monitoring. Body weight, circumferences, and blood pressure are reassessed.
Visit 5 (Week 12, post-intervention): Full reassessment mirroring Visit 2. Participants are debriefed, compensated, and provided with post-intervention materials. Perceived allocation (control vs. intervention) and acceptability/feasibility of the diet are also evaluated.
Visit 6 (Optional follow-up at Week 24): Evaluation of sustained effects on ADHD symptoms, quality of life, adherence, and feasibility. Stool sample is collected, anthropometry is repeated, and diet is logged again.
During the intervention, participants track their diet using a smartphone app (Nutritics/Libro) and receive weekly email support. Participants also receive personalized dietary advice according to their group allocation: a minimum of 25 grams of fiber and 3 servings of fermented foods per day for those in the combined diet group; or, for those in the control diet group, adherence to the standard food pyramid (daily portions include 5-7 servings of fruits and vegetables, 3-5 servings of whole grains, 2 servings of lean protein such as meat, fish, eggs, or legumes, 3 servings of low-fat dairy, and limited intake of fats, oils, and sweets).
Biological samples (stool, saliva, urine, blood) will be collected at multiple timepoints. Stool samples will be used for microbiota profiling (16S rRNA sequencing and metagenomics) and metabolomics (e.g., short-chain fatty acids). Saliva and urine will be analyzed for stress-related hormones, metabolomics and specific metabolites of interest. Blood samples will be analyzed for inflammatory cytokines, stress-related hormones, metabolomics, and other potential biomarkers that might be emerging when the sample recruitment is finalized. A subset of participants will undergo a skin punch biopsy to generate a human-derived cell model for investigating causal cellular mechanisms in response to microbial metabolites.
Neurocognitive and neural data will be collected using EEG tasks and computerized cognitive tasks assessing impulsivity and attention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No ADHD/Combined Diet | Experimental | Other: Combined dietParticipants without ADHD will receive a combined diet (fermented foods and high fiber) |
| No ADHD/Control diet | No intervention | –Participants without ADHD will receive dietary education based on the healthy eating guidelines provided by the Health Service Executive (HSE). |
| ADHD/Control diet | No intervention | –Participants with ADHD will receive dietary education based on the healthy eating guidelines provided by the Health Service Executive (HSE). |
| ADHD/Combined diet | Experimental | Other: Combined dietParticipants with ADHD will receive a combined diet (fermented foods and high fiber) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined dietParticipants 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. | Other | ADHD/Combined diet, No ADHD/Combined Diet |
Primary outcome
Change in ADHD core symptoms
Time frame: From baseline to 12 weeks
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).
1 secondary outcome
Change in neurocognitive function and mood, and other secondary domains
Time frame: From baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 31517183Brysbaert M, Stevens M. Power Analysis and Effect Size in Mixed Effects Models: A Tutorial. J Cogn. 2018 Jan 12;1(1):9. doi: 10.5334/joc.10.
- Background: PubMed 16420712Faraone SV, Biederman J, Mick E. The age-dependent decline of attention deficit hyperactivity disorder: a meta-analysis of follow-up studies. Psychol Med. 2006 Feb;36(2):159-65. doi: 10.1017/S003329170500471X.
- Background: PubMed 40753077Konstanti P, Ahrens KF, Neumann RJ, Plichta MM, Schiweck C, Ruf A, Fiebach CJ, Kalisch R, Basten U, Wessa M, Tuescher O, Kollmann B, Lieb K, Arias-Vasquez A, Smidt H, Reif A, Matura S, Belzer C. Impulsivity among healthy adults is associated with diet and fecal microbiota composition. Transl Psychiatry. 2025 Aug 3;15(1):263. doi: 10.1038/s41398-025-03483-4.
- Background: PubMed 34750307Berding K, Cryan JF. Microbiota-targeted interventions for mental health. Curr Opin Psychiatry. 2022 Jan 1;35(1):3-9. doi: 10.1097/YCO.0000000000000758.
- Background: PubMed 38280441Ribera C, Sanchez-Orti JV, Clarke G, Marx W, Morkl S, Balanza-Martinez V. Probiotic, prebiotic, synbiotic and fermented food supplementation in psychiatric disorders: A systematic review of clinical trials. Neurosci Biobehav Rev. 2024 Mar;158:105561. doi: 10.1016/j.neubiorev.2024.105561. Epub 2024 Jan 26.
- Background: PubMed 31744191Bull-Larsen S, Mohajeri MH. The Potential Influence of the Bacterial Microbiome on the Development and Progression of ADHD. Nutrients. 2019 Nov 17;11(11):2805. doi: 10.3390/nu11112805.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined diet in people with ADHD, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerard Clarke, PhD (+3530214901224, g.clarke@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD core symptoms (time frame: From baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376746, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.