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Attention Deficit Hyperactivity Disorder: Nutrition and Environment

Primary Purpose

ADHD, Lifestyle-Related Condition, Food Habits

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nutritional education
Sponsored by
Hospital El Escorial
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ADHD focused on measuring adhd treatment, nutrition

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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...

Sites / Locations

  • Hospital EL EscorialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutritional intervention

No intervention

Arm Description

Patients subject to nutritional education by CINUSA group protocol

Patients not subject to nutritional education

Outcomes

Primary Outcome Measures

Change in Conners
Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type.

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2016
Last Updated
December 20, 2016
Sponsor
Hospital El Escorial
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1. Study Identification

Unique Protocol Identification Number
NCT02999503
Brief Title
Attention Deficit Hyperactivity Disorder: Nutrition and Environment
Official Title
Nutritional and Environmental Conditions in Attention Deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital El Escorial

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: cases (ADHD) and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Lifestyle-Related Condition, Food Habits
Keywords
adhd treatment, nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional intervention
Arm Type
Experimental
Arm Description
Patients subject to nutritional education by CINUSA group protocol
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Patients not subject to nutritional education
Intervention Type
Behavioral
Intervention Name(s)
Nutritional education
Intervention Description
Nutritional education trough a personal online nutritional consultant
Primary Outcome Measure Information:
Title
Change in Conners
Description
Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type.
Time Frame
At 3 and 6 months
Secondary Outcome Measure Information:
Title
Change in sleep
Description
Markers related to sleep: adapted Short Form Health Survey-36 for sleep quality.
Time Frame
At 3 and 6 months
Title
Change in exercise markers
Description
Markers related to activity: Ipad-Minnesota questionnaire for physical activity.
Time Frame
At 3 and 6 months
Title
Change in Anthropometry I
Description
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.
Time Frame
At 3 and 6 months
Title
Change in Anthropometry II
Description
BMI, calculated using height and weight.
Time Frame
At 3 and 6 months
Title
Change in Anthropometry III
Description
% 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.
Time Frame
At 3 and 6 months
Title
Change in Anthropometry IV
Description
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.
Time Frame
At 3 and 6 months
Title
Change in nutritional habits
Description
Kidmed ( mediterranean diet adherence) questionnaire at baseline, 3 and 6 month
Time Frame
At 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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...
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Andrés Blumenfeld Olivares, MD
Phone
+34625284294
Email
javierandres.blumenfeld@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ismael San Mauro Martin, PhD
Email
isma182@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Andres Blumenfeld Olivares, MD
Organizational Affiliation
Hospital El Escoral
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital EL Escorial
City
San Lorenzo de El Escorial
State/Province
Madrid
ZIP/Postal Code
28200
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
javier andres BLumenfeld Olivares
Email
javierandres.blumenfeld@salud.madrid.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Attention Deficit Hyperactivity Disorder: Nutrition and Environment

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