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ADHDNCT02999503

Attention Deficit Hyperactivity Disorder: Nutrition and Environment

A study testing Nutritional education in people with ADHD and Lifestyle-Related Condition, run by Hospital El Escorial at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 8 to 16 years
Conditions the study is for
ADHD, Lifestyle-Related Condition, Food Habits
What is being tested?
Nutritional education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSpain
Study dates
Nov 2016to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Javier Andrés Blumenfeld Olivares, MD contact

+34625284294

javierandres.blumenfeld@salud.madrid.org

Ismael San Mauro Martin, PhD contact

isma182@hotmail.com

Spain1 site, 1 recruiting
  • Hospital EL Escorial

    El Escorial, Madrid, 28200

    javier andres BLumenfeld Olivares, javierandres.blumenfeld@salud.madrid.org

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Nutritional education
Keywords
adhd treatment, nutrition
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Mental Disorders, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional educationBehavioural

    Nutritional education trough a personal online nutritional consultant

Study groups in NCT02999503
Study groupRoleWhat they receive
Nutritional interventionExperimentalPatients subject to nutritional education by CINUSA group protocol
Receives: Behavioral: Nutritional education
No interventionNo interventionPatients not subject to nutritional education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Conners

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

    Measured: At 3 and 6 months

Secondary outcomes (7)
  1. Change in sleep

    Markers related to sleep: adapted Short Form Health Survey-36 for sleep quality.

    Measured: At 3 and 6 months

  2. Change in exercise markers

    Markers related to activity: Ipad-Minnesota questionnaire for physical activity.

    Measured: At 3 and 6 months

  3. 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.

    Measured: At 3 and 6 months

  4. Change in Anthropometry II

    BMI, calculated using height and weight.

    Measured: At 3 and 6 months

  5. 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.

    Measured: At 3 and 6 months

  6. 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.

    Measured: At 3 and 6 months

  7. Change in nutritional habits

    Kidmed ( mediterranean diet adherence) questionnaire at baseline, 3 and 6 month

    Measured: At 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionMay 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999503
Sponsor's protocol ID
CINUSA1
Status last verified
Dec 2016
First submitted
1 Dec 2016
Last updated
21 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

    PubMed 37058600

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional education in people with ADHD and Lifestyle-Related Condition, run by Hospital El Escorial at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Javier Andrés Blumenfeld Olivares, MD (+34625284294, javierandres.blumenfeld@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Conners (time frame: At 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02999503, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.

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