Early Phase 1 Completed N=64 Randomized Single-blind Supportive Care

Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein

ADD · ADHD

Source: ClinicalTrials.gov NCT01856686 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcomePrimary: Reaction Time at 3 Months — 506.58; 510.59 milliseconds — p=0.56593

Summary

Multicenter, Prospective, randomized, comparative and controlled study about the beneficial effects in behavior and brain connectivity of different dietary patterns in 100 children with ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.

Outcome Measures

Outcome	Result	p-value
PRIMARY Reaction Time at 3 Months	506.58; 510.59	0.56593
PRIMARY Omission Errors at 3 Months	17.15; 14.95	0.71152
PRIMARY Comission Errors at 3 Months	2.19; 2.82	0.10036
PRIMARY Occipital Alpha Brainwaves Amplitudes at 3 Months	12.25; 11.99	0.08946
PRIMARY Mu Waves-amplitude at 3 Months	6.32; 6.05	0.05158
PRIMARY Frontal Midline Theta Activity- Amplitude at 3 Months	6.81; 9.13	0.39707
SECONDARY Occipital Alpha Waves-frequency at 3 Months	9.71; 9.60	0.92193
SECONDARY Parietal Alpha Waves-frequency at 3 Months	8.96; 9.21	0.73209
SECONDARY Mu Wave Frequency at 3 Months	9.06; 9.07	0.94449
SECONDARY Frontal Midline Theta Activity- Frequency at 3 Months	4.70; 4.76	0.83929
SECONDARY Monastra Ratio at 3 Months	16.88; 22.36	0.17383
SECONDARY Behavior	13.08; 12.45	0.50964
SECONDARY Hyperactivity Score	3.04; 2.68	0.45013
SECONDARY Impulsivity Score	3.96; 3.55	0.23226
SECONDARY Inattention Score	6.08; 6.23	0.90843

Eligibility Criteria

Inclusion Criteria

ADHD diagnosed 12 months before
no take medication
BMI above the 25th percentile
Wiesel score between 80 and 100 (about 120)
Patients who agree to participate and whose guardians signed the informed consent form

Exclusion Criteria

eating disorders
psychosis, bipolar disorder or depression
kidney or liver failure
diabetes
diuretic or cortisone treatment
haematological problems
suprarenal diseases
cancer
Brain injury
Cardiovascular or arrhythmia problems

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01856686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.