<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02999503</url>
  </required_header>
  <id_info>
    <org_study_id>CINUSA1</org_study_id>
    <nct_id>NCT02999503</nct_id>
  </id_info>
  <brief_title>Attention Deficit Hyperactivity Disorder: Nutrition and Environment</brief_title>
  <official_title>Nutritional and Environmental Conditions in Attention Deficit Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital El Escorial</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital El Escorial</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators aim to investigate the relationship between environmental&#xD;
      factors, lifestyle and symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Initially&#xD;
      the investigators intend to measure the relationship between nutritional quality, exercise&#xD;
      and sleep and ADHD symptoms. And then measure whether a change made in the diet can improve&#xD;
      the symptoms of ADHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Attention Deficit Hyperactivity Disorder is a neurobiological chronic disorder,&#xD;
      symptomatically evolutionary and of probable genetic transmission that affects between 5 and&#xD;
      10% of the child population.&#xD;
&#xD;
      The current opinion on the etiology of the disorder focuses on a failure in the development&#xD;
      of brain circuits in which inhibition and self-control, critical functions to perform any&#xD;
      task, gets supported. In addition, there is greater evidence of knowledge of the genetic&#xD;
      influence as a major part of the etiology of ADHD. Studies suggest that ADHD is familiar and&#xD;
      that genetic influences may contribute to its etiology from moderate to high phenotypic&#xD;
      expression. Current studies have identified significant associations with several candidate&#xD;
      genes for this disorder, including DAT1, DRD4, DRD5, 5HTT, HTR1B or SNAP25.&#xD;
&#xD;
      Meta-analytical studies are needed to develop a more personalized treatment for ADHD. Other&#xD;
      factors associated with ADHD are inadequate lifestyles by parents, especially during the&#xD;
      gestation period in the case of the mother. ADHD treatment includes the use of medication and&#xD;
      psychosocial and educational support&#xD;
&#xD;
      FOOD, NUTRITION AND ADHD: A NEW PARADIGM OF THERAPY?&#xD;
&#xD;
      Despite the above, with the use of internet many hypotheses have emerged, not yet proven,&#xD;
      many in relation to food of patients with ADHD, in which a single focus is exposed as the&#xD;
      determinant factor: heavy metals; gluten and dairy; additives; or intake of certain&#xD;
      supplements.&#xD;
&#xD;
      The truth is that, neuronal function is strongly influenced by substances in the diet, which&#xD;
      are very important for its functioning. Many micronutrients have been evaluated, including&#xD;
      mainly vitamins B6, B12, B9, D and E along with some minerals like magnesium, selenium and&#xD;
      zinc. Their actions are related to memory, neurotransmitter synthesis and neurological&#xD;
      protection.&#xD;
&#xD;
      Multiple studies have found magnesium deficiency in patients with ADHD, as reported in&#xD;
      relation to other nutrients. What has also led to study specifically the use of&#xD;
      supplementation, in patients with ADHD, with zinc, magnesium, phytochemicals, omega-3&#xD;
      traditional herbs or mixtures of these elements.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
        -  Main objective:&#xD;
&#xD;
             -  Rating, by analysis of results, environmental, nutritional and body composition&#xD;
                factors, which may affect the pathogenesis and symptoms of ADHD patients.&#xD;
&#xD;
        -  Specific objectives (project sub-lines):&#xD;
&#xD;
             -  Heritage and programming: assessing the hereditary role, as the main factor for the&#xD;
                development of ADHD: genetics, nursing, toxic habits in parents and birth&#xD;
                characteristics.&#xD;
&#xD;
             -  Diet and physical activity: assessing the role of specific nutrients, eating&#xD;
                patterns, exercise, sedentary lifestyle, leisure type and cognitive entertainment,&#xD;
                in the development of ADHD.&#xD;
&#xD;
             -  Body Composition: assessing body fat accumulation and muscle mass, aspects involved&#xD;
                in the metabolism of people with ADHD.&#xD;
&#xD;
      DESIGN&#xD;
&#xD;
      Cross-sectional study of observational, descriptive and comparative cohort. It consists of&#xD;
      volunteer participants, divided into two study groups:&#xD;
&#xD;
        1. cases (ADHD) and&#xD;
&#xD;
        2. controls (healthy, with no ADHD).&#xD;
&#xD;
      For the initial design and protocols main databases have been revised (Scielo, PubMed,&#xD;
      ENBASE...).&#xD;
&#xD;
      Development: An observational retrospective cohort study.&#xD;
&#xD;
      Incidental sample: n = 70-100 (approximately 35-50 subjects per group, of the same age&#xD;
      range).&#xD;
&#xD;
      Inclusion criteria: both genders, ages 8-16 years.&#xD;
&#xD;
      Intervention trial. A personalized diet for patients will be performed. After completion of&#xD;
      the diet, the effect of the intervention on ADHD symptomatology will be measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Conners</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <description>Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in sleep</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <description>Markers related to sleep: adapted Short Form Health Survey-36 for sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in exercise markers</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <description>Markers related to activity: Ipad-Minnesota questionnaire for physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anthropometry I</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anthropometry II</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <description>BMI, calculated using height and weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anthropometry III</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anthropometry IV</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nutritional habits</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <description>Kidmed ( mediterranean diet adherence) questionnaire at baseline, 3 and 6 month</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>ADHD</condition>
  <condition>Lifestyle-Related Condition</condition>
  <condition>Food Habits</condition>
  <arm_group>
    <arm_group_label>Nutritional intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients subject to nutritional education by CINUSA group protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients not subject to nutritional education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional education</intervention_name>
    <description>Nutritional education trough a personal online nutritional consultant</description>
    <arm_group_label>Nutritional intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Ages 8-16 years&#xD;
&#xD;
          -  ADHD proved&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of serious or chronic illnesses: leukemia, spinal cord injury, celiac&#xD;
             disease, pancreatitis, hepatitis, HIV...&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Andres Blumenfeld Olivares, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital El Escoral</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Javier Andrés Blumenfeld Olivares, MD</last_name>
    <phone>+34625284294</phone>
    <email>javierandres.blumenfeld@salud.madrid.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ismael San Mauro Martin, PhD</last_name>
    <email>isma182@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital EL Escorial</name>
      <address>
        <city>San Lorenzo de El Escorial</city>
        <state>Madrid</state>
        <zip>28200</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>javier andres BLumenfeld Olivares</last_name>
      <email>javierandres.blumenfeld@salud.madrid.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital El Escorial</investigator_affiliation>
    <investigator_full_name>Blumenfeld Olivares JA</investigator_full_name>
    <investigator_title>Pediatrician, Responsible of Pediatric Endocrinology. Principal Investigator.</investigator_title>
  </responsible_party>
  <keyword>adhd treatment</keyword>
  <keyword>nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999503
org study id: CINUSA1
nct id: NCT02999503
lead sponsor: 
has dmc: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Conners
time frame: At 3 and 6 months
description: Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type.
measure: Change in sleep
time frame: At 3 and 6 months
description: Markers related to sleep: adapted Short Form Health Survey-36 for sleep quality.
measure: Change in exercise markers
time frame: At 3 and 6 months
description: Markers related to activity: Ipad-Minnesota questionnaire for physical activity.
measure: Change in Anthropometry I
time frame: At 3 and 6 months
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.
measure: Change in Anthropometry II
time frame: At 3 and 6 months
description: BMI, calculated using height and weight.
measure: Change in Anthropometry III
time frame: At 3 and 6 months
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.
measure: Change in Anthropometry IV
time frame: At 3 and 6 months
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.
measure: Change in nutritional habits
time frame: At 3 and 6 months
description: Kidmed ( mediterranean diet adherence) questionnaire at baseline, 3 and 6 month
arm group label: Nutritional intervention
arm group type: Experimental
description: Patients subject to nutritional education by CINUSA group protocol
arm group label: No intervention
arm group type: No Intervention
description: Patients not subject to nutritional education
intervention type: Behavioral
intervention name: Nutritional education
description: Nutritional education trough a personal online nutritional consultant
arm group label: Nutritional intervention
criteria: 
gender: All
minimum age: 8 Years
maximum age: 16 Years
healthy volunteers: No
last name: Javier Andres Blumenfeld Olivares, MD
role: Principal Investigator
affiliation: Hospital El Escoral
last name: Javier Andrés Blumenfeld Olivares, MD
phone: +34625284294
email: javierandres.blumenfeld@salud.madrid.org
last name: Ismael San Mauro Martin, PhD
email: isma182@hotmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital El Escorial
investigator full name: Blumenfeld Olivares JA
investigator title: Pediatrician, Responsible of Pediatric Endocrinology. Principal Investigator.
mesh term: Disease
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: Undecided