An interventional study of Diet modification in ADHD and Diet Modification, sponsored by St Mary's University College. Status unknown at 1 site in United Kingdom. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by St Mary's University College · Not applicable, Interventional, and Other
The aim is to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.
Children with Attention Deficit Hyperactivity Disorder (ADHD) can suffer debilitating symptoms, including problematic behaviour and sleep. Research suggests dietary manipulations may be a helpful treatment option for children with ADHD, although the most effective are highly restrictive, with little known about why they might work. Optimising gut bacteria in individuals with ADHD may help alleviate some of the symptoms of this condition via the gut-brain-axis and would provide a plausible mechanism by which dietary interventions operate. We propose to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.
1,548 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.
This study's enrollment of 9 is below the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →St Mary's University College is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Diet modification
The parents will have four group sessions with a nutritional therapist, where in depth advice and information about the diet will be provided. Ongoing support will also be provided throughout the study by use of a closed Facebook or WhatsApp group (whichever the parents choose as most appropriate). The diet is based on five main principles: * Eat at least seven portions of different varieties of fruit and vegetables each day. * Have a 12 hour overnight break from food (water only during this time). * Drink a Kefir drink each day - provided free of charge. * Eat a microbiome friendly, protein rich, breakfast from our menu. * Reduce sugar and artificial sweeteners.
Completion of study
What proportion of participants completed the study?
Time frame: final week
Adherence to diet
Percentage adherence to diet over the 4-week period based on parental report (range 0-100 % - high score reflecting greater degree of adherence).
Time frame: week 6 of diet
Side-effects
Parent-reported side effects during course of study. (Qualitative) (More/more side-effects reflect poorer outcome).
Time frame: duration of the 6 week diet
The Conners Clinical Index (Conners CI) - Parent-report
Parental report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms) 1. Disruptive Behavior Indicator 2. Learning and Language Disorder Indicator 3. Mood Disorder Indicator 4. Anxiety Disorder Indicator 5. ADHD Indicator
Time frame: Baseline and week 6 of diet
The Conners Clinical Index (Conners CI) - Teacher-report
Teacher report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms) 1. Disruptive Behavior Indicator 2. Learning and Language Disorder Indicator 3. Mood Disorder Indicator 4. Anxiety Disorder Indicator 5. ADHD Indicator
Time frame: Baseline and week 6 of diet
The Conners Clinical Index (Conners CI) - Self-report
Child self-report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms) 1. Disruptive Behavior Indicator 2. Learning and Language Disorder Indicator 3. Mood Disorder Indicator 4. Anxiety Disorder Indicator 5. ADHD Indicator
Time frame: Baseline and week 6 of diet
Delayed Match to Sample test (Cambridge Neuropsychological Test Automated Battery - CANTAB) Latency (response time) Accuracy (correct patterns selected).
Computerised test of visual working memory * DMS Percent Correct (overall, for all delays, simultaneous, 0 sec delay, 4 sec delay, 12 sec delay). Range 0-100% - higher score reflects greater accuracy. * DMS Mean \& Median Correct Latency (overall, for all delays, simultaneous, 0 sec delay, 4 sec delay, 12 sec delay). Range 0-∞ ms - higher score reflects worse performance. * DMS Correct Latency Standard Deviation. Range 0-∞ ms - higher score reflects worse performance. * DMS Mean Choices to Correct response. Range 0-4 - higher score reflects worse performance. * DMS Probability of Error Given Error. Range 0-1 - higher score reflects worse performance.
Time frame: Baseline and week 6 of diet
The Consensus Sleep Diary
Record of sleep - used qualitatively to detect and remove artefacts from the data.
Time frame: Baseline and week 6 of diet
Children's Sleep Habits Questionnaire
Parental report of child's sleep A Total Sleep Disturbances score is calculated as the sum of all CSHQ scored questions, and can range from 33 to 99. A higher score indicates more problematic sleep.
Time frame: Baseline and week 6 of diet
Sleep self-report questionnaire
Week long retrospective sleep survey (Scores range from 13-39 with a higher score indicating more/more severe sleep difficulties).
Time frame: Baseline and week 6 of diet
Actigraphy recordings
Objective measure of sleep quality and daytime activity * Mean activity during sleep. Range 0-∞. A higher score = less sound sleep (worse). * Minutes spent awake during the down period. Range 0-∞. A higher score = less sound sleep (worse). * Sleep latency (time taken to fall asleep). Range 0-∞. A higher score = more time taken to fall asleep (worse). * Sleep efficiency (% down period spent asleep, after removing sleep latency). A higher score = better. * Wake after sleep onset (minutes spent awake during the down period after removing sleep latency). Range 0-∞. A higher score = less sound sleep (worse). * Sleep fragmentation (number of awakenings/ total minutes of sleep x 100) - Higher score = more fragmented sleep (worse). * Mean daytime activity (0-∞) not necessarily worse or better.
Time frame: Baseline and week 6 of diet
The Gastrointestinal Symptom Rating
Questionnaire to evaluate common gastrointestinal symptoms Total scores range from 15-105 (with higher scores reflecting more/more severe gastrointestinal symptoms). Subscales: 1. Abdominal pain (abdominal pain, hunger pains and nausea). Range 3-21 - a high score reflects worse symptoms. 2. Reflux syndrome (heartburn and acid regurgitation). Range 3-21 - a high score reflects worse symptoms. 3. Diarrhoea syndrome (diarrhoea, loose stools and urgent need for defecation). Range 3-21 - a high score reflects worse symptoms. 4. Indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus). Range 3-21 - a high score reflects worse symptoms. Range 3-21 - a high score reflects worse symptoms. 5. Constipation syndrome (constipation, hard stools and feeling of incomplete evacuation). Range 3-21 - a high score reflects worse symptoms.
Time frame: Baseline and week 6 of diet
Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing
Analysis of bacterial strains and diversity within stool sample
Time frame: Baseline and week 6 of diet
Treatment Acceptability Scale
Questionnaire to assess the acceptability of the diet to parents of the children taking part in the study Score range 6-42 (High score reflects more positive attitude to treatment)
Time frame: Baseline and week 6 of diet
Plan to share: Undecided — At the request of individual researchers.
Started May 2019 (actual). Primary completion is estimated for Jul 2019, 2 months after the start.
Of 393 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 2 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Attention Deficit Disorder with Hyperactivity →
St Mary's University College