Improving ADHD Core Symptoms and Individual Quality of Life With Dietary APproaches Through Microbiota-Gut-Brain Signalling
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in ADHD core symptoms
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a double-blind study where both participants and outcomes assessors are blinded to group allocation. Randomization and assignment to dietary groups will be conducted by a staff member not involved in study visits or data analysis as well as the organisation of fermented food deliveries. Dietary counselling will be delivered by a separate dietitian who is aware of group allocation but has no role in outcome assessment or other study procedures.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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/m
- •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.
研究组 & 干预措施
No ADHD/Combined Diet
Participants without ADHD will receive a combined diet (fermented foods and high fiber)
干预措施: Combined diet (Other)
No ADHD/Control diet
Participants without ADHD will receive dietary education based on the healthy eating guidelines provided by the Health Service Executive (HSE).
ADHD/Control diet
Participants with ADHD will receive dietary education based on the healthy eating guidelines provided by the Health Service Executive (HSE).
ADHD/Combined diet
Participants with ADHD will receive a combined diet (fermented foods and high fiber)
干预措施: Combined diet (Other)
结局指标
主要结局
Change in ADHD core symptoms
时间窗: 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).
次要结局
- Change in neurocognitive function and mood, and other secondary domains(From baseline to 12 weeks)
研究者
John Cryan
PhD
University College Cork