Attention Deficit Hyperactivity Disorder: Nutrition and Environment

ADHD Clinical Trial

Official title:

Nutritional and Environmental Conditions in Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02999503
• Other study ID #: CINUSA1
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2016
• Last updated: December 20, 2016
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Hospital El Escorial
• Contact: Javier Andrés Blumenfeld Olivares, MD
• Phone: +34625284294
• Email: javierandres.blumenfeld[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

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...

Study Design

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Disease
• Food Habits
• Lifestyle-Related Condition

Intervention

Behavioral:
• Nutritional education
Nutritional education trough a personal online nutritional consultant

Locations

Country	Name	City	State
Spain	Hospital EL Escorial	San Lorenzo de El Escorial	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital El Escorial

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Conners	Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type.	At 3 and 6 months	Yes
Secondary	Change in sleep	Markers related to sleep: adapted Short Form Health Survey-36 for sleep quality.	At 3 and 6 months	Yes
Secondary	Change in exercise markers	Markers related to activity: Ipad-Minnesota questionnaire for physical activity.	At 3 and 6 months	Yes
Secondary	Change in Anthropometry I	Arm circumference and triceps skinfold, muscle area and arm fat area using the manual for evaluation of body composition in humans of the Spanish population.	At 3 and 6 months	Yes
Secondary	Change in Anthropometry II	BMI, calculated using height and weight.	At 3 and 6 months	Yes
Secondary	Change in Anthropometry III	% total body fat,% visceral fat,% muscle. Measured by electrical bioimpedance, apparatus for medical use which analyzes the opposition of a biological tissue (fat) to the passage of an electric current through it. It is a noninvasive, painless study based on the application of an electrical current through the body and the record of physical parameters that depend on body's water content. The investigators will use a M230 InBody bioimpedance, multi-frequency (20 to 100 Hz), tetra-pole or similar.	At 3 and 6 months	Yes
Secondary	Change in Anthropometry IV	Arm circumference and triceps skinfold, muscle area and arm fat area using the manual for evaluation of body composition in humans of the Spanish population.	At 3 and 6 months	Yes
Secondary	Change in nutritional habits	Kidmed ( mediterranean diet adherence) questionnaire at baseline, 3 and 6 month	At 3 and 6 months