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Clinical Trial Summary

In this study the investigators aim to investigate the relationship between environmental factors, lifestyle and symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Initially the investigators intend to measure the relationship between nutritional quality, exercise and sleep and ADHD symptoms. And then measure whether a change made in the diet can improve the symptoms of ADHD.

Clinical Trial Description

The Attention Deficit Hyperactivity Disorder is a neurobiological chronic disorder, symptomatically evolutionary and of probable genetic transmission that affects between 5 and 10% of the child population.

The current opinion on the etiology of the disorder focuses on a failure in the development of brain circuits in which inhibition and self-control, critical functions to perform any task, gets supported. In addition, there is greater evidence of knowledge of the genetic influence as a major part of the etiology of ADHD. Studies suggest that ADHD is familiar and that genetic influences may contribute to its etiology from moderate to high phenotypic expression. Current studies have identified significant associations with several candidate genes for this disorder, including DAT1, DRD4, DRD5, 5HTT, HTR1B or SNAP25.

Meta-analytical studies are needed to develop a more personalized treatment for ADHD. Other factors associated with ADHD are inadequate lifestyles by parents, especially during the gestation period in the case of the mother. ADHD treatment includes the use of medication and psychosocial and educational support


Despite the above, with the use of internet many hypotheses have emerged, not yet proven, many in relation to food of patients with ADHD, in which a single focus is exposed as the determinant factor: heavy metals; gluten and dairy; additives; or intake of certain supplements.

The truth is that, neuronal function is strongly influenced by substances in the diet, which are very important for its functioning. Many micronutrients have been evaluated, including mainly vitamins B6, B12, B9, D and E along with some minerals like magnesium, selenium and zinc. Their actions are related to memory, neurotransmitter synthesis and neurological protection.

Multiple studies have found magnesium deficiency in patients with ADHD, as reported in relation to other nutrients. What has also led to study specifically the use of supplementation, in patients with ADHD, with zinc, magnesium, phytochemicals, omega-3 traditional herbs or mixtures of these elements.


- Main objective:

- Rating, by analysis of results, environmental, nutritional and body composition factors, which may affect the pathogenesis and symptoms of ADHD patients.

- Specific objectives (project sub-lines):

- Heritage and programming: assessing the hereditary role, as the main factor for the development of ADHD: genetics, nursing, toxic habits in parents and birth characteristics.

- Diet and physical activity: assessing the role of specific nutrients, eating patterns, exercise, sedentary lifestyle, leisure type and cognitive entertainment, in the development of ADHD.

- Body Composition: assessing body fat accumulation and muscle mass, aspects involved in the metabolism of people with ADHD.


Cross-sectional study of observational, descriptive and comparative cohort. It consists of volunteer participants, divided into two study groups:

1. cases (ADHD) and

2. controls (healthy, with no ADHD).

For the initial design and protocols main databases have been revised (Scielo, PubMed, ENBASE...).

Development: An observational retrospective cohort study.

Incidental sample: n = 70-100 (approximately 35-50 subjects per group, of the same age range).

Inclusion criteria: both genders, ages 8-16 years.

Intervention trial. A personalized diet for patients will be performed. After completion of the diet, the effect of the intervention on ADHD symptomatology will be measured. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

NCT number NCT02999503
Study type Interventional
Source Hospital El Escorial
Contact Javier Andrés Blumenfeld Olivares, MD
Phone +34625284294
Email [email protected]
Status Recruiting
Phase N/A
Start date November 2016
Completion date June 2017

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