CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 64 enrolled
Drug / intervention
BP22042013 +1 moredrug
Likely dose
BP22042013 60 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01856686
NCT01856686Early Ph 1Completed
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Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein

Spanish Foundation for Neurometrics Development·interventional·Posted May 17, 2013·Updated May 8, 2024

In Brief

A Early Phase 1 clinical trial evaluating BP22042013 and Low carbohydrate diet for ADD and ADHD. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADD, ADHD
CountriesUnited Kingdom
CollaboratorsPronoKal Foundation, Child Health Foundation

Timeline

Early Ph 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 17, 2013
Enrollment StartDec 1, 2013
Primary CompletionJun 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.1 years ago

Interventions

BP22042013drug

This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.

Low carbohydrate dietdietary

the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements