Attention Deficit Hyperactivity Disorder: Nutrition and Environment

Nutritional and Environmental Conditions in Attention Deficit Hyperactivity Disorder

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.

Study Overview

• Status: Unknown
• Conditions: ADHD; Food Habits; Lifestyle-Related Condition
• Intervention / Treatment: Behavioral: Nutritional education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • San Lorenzo de El Escorial, Madrid, Spain, 28200
      • Recruiting
      • Hospital El Escorial
      • Contact: javier andres BLumenfeld Olivares; Email: javierandres.blumenfeld@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nutritional intervention; Patients subject to nutritional education by CINUSA group protocol	Behavioral: Nutritional education; Nutritional education trough a personal online nutritional consultant
NO_INTERVENTION: No intervention; Patients not subject to nutritional education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Conners	Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type.	At 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep	Markers related to sleep: adapted Short Form Health Survey-36 for sleep quality.	At 3 and 6 months
Change in exercise markers	Markers related to activity: Ipad-Minnesota questionnaire for physical activity.	At 3 and 6 months
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
Change in Anthropometry II	BMI, calculated using height and weight.	At 3 and 6 months
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
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
Change in nutritional habits	Kidmed ( mediterranean diet adherence) questionnaire at baseline, 3 and 6 month	At 3 and 6 months

Collaborators and Investigators

• Sponsor: Hospital El Escorial
• Investigators: Principal Investigator: Javier Andres Blumenfeld Olivares, MD, Hospital El Escoral

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): May 1, 2017
• Study Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (ESTIMATE): December 21, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 21, 2016
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: nutrition; adhd treatment
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: CINUSA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED