Clinical trial NCT02999503: Attention Deficit Hyperactivity Disorder: Nutrition and Environment
Official title: Nutritional and Environmental Conditions in Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Lifestyle-Related Condition
Food Habits
Keywords: adhd treatment
nutrition
Lead sponsor: Hospital El Escorial
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

FOOD, NUTRITION AND ADHD: A NEW PARADIGM OF THERAPY?

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.

OBJECTIVES

* 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.

DESIGN

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.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Ages 8-16 years
* ADHD proved

Exclusion Criteria:

* Presence of serious or chronic illnesses: leukemia, spinal cord injury, celiac disease, pancreatitis, hepatitis, HIV...

Primary outcomes:
measure: Change in Conners
timeFrame: At 3 and 6 months
Secondary outcomes:
measure: Change in sleep
timeFrame: At 3 and 6 months
measure: Change in exercise markers
timeFrame: At 3 and 6 months
measure: Change in Anthropometry I
timeFrame: At 3 and 6 months
measure: Change in Anthropometry II
timeFrame: At 3 and 6 months
measure: Change in Anthropometry III
timeFrame: At 3 and 6 months
measure: Change in Anthropometry IV
timeFrame: At 3 and 6 months
measure: Change in nutritional habits
timeFrame: At 3 and 6 months
Other outcomes:
Locations:
city: San Lorenzo de El Escorial
country: Spain
facility: Hospital EL Escorial
state: Madrid
Study officials:
affiliation: Hospital El Escoral
name: Javier Andres Blumenfeld Olivares, MD
role: PRINCIPAL_INVESTIGATOR
References: