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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Ismael San Mauro Martin, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital EL Escorial
El Escorial, Madrid, 28200
javier andres BLumenfeld Olivares, javierandres.blumenfeld@salud.madrid.org
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:
- 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.
- Conditions
- ADHD, Lifestyle-Related Condition, Food Habits
- 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 group | Role | What they receive |
|---|---|---|
| Nutritional intervention | Experimental | Patients subject to nutritional education by CINUSA group protocol Receives: Behavioral: Nutritional education |
| No intervention | No intervention | Patients not subject to nutritional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Change in sleep
Markers related to sleep: adapted Short Form Health Survey-36 for sleep quality.
Measured: At 3 and 6 months
Change in exercise markers
Markers related to activity: Ipad-Minnesota questionnaire for physical activity.
Measured: 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.
Measured: At 3 and 6 months
Change in Anthropometry II
BMI, calculated using height and weight.
Measured: 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.
Measured: 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.
Measured: At 3 and 6 months
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.
- First posted21 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital El Escorial
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blumenfeld Olivares JA, Hospital El Escorial
- Investigators
- Javier Andres Blumenfeld Olivares, MD, Principal investigator, Hospital El Escoral
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Environmental Conditions in Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02999503
- Acronym / sponsor ID
- CINUSA1
- Conditions
- ADHD, Lifestyle-Related Condition, Food Habits
- Keywords
- adhd treatment, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital El EscorialUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention | Experimental | Behavioral: Nutritional educationPatients subject to nutritional education by CINUSA group protocol |
| No intervention | No intervention | –Patients not subject to nutritional education |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Both genders
- Ages 8-16 years
- ADHD proved
Key exclusion criteria (1 listed)
- Presence of serious or chronic illnesses: leukemia, spinal cord injury, celiac disease, pancreatitis, hepatitis, HIV...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional educationNutritional education trough a personal online nutritional consultant | Behavioural | Nutritional intervention |
Primary outcome
Change in Conners
Time frame: At 3 and 6 months
Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type.
7 secondary outcomes
Change in sleep
Time frame: At 3 and 6 months
Change in exercise markers
Time frame: At 3 and 6 months
Change in Anthropometry I
Time frame: At 3 and 6 months
Change in Anthropometry II
Time frame: At 3 and 6 months
Change in Anthropometry III
Time frame: At 3 and 6 months
Change in Anthropometry IV
Time frame: At 3 and 6 months
Change in nutritional habits
Time frame: At 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Derived from this study: PubMed 37058600Gillies 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismael San Mauro Martin, PhD contact
Javier Andres Blumenfeld Olivares, MD principal investigator
Hospital El Escoral
1 site in 1 country: see every site and its status.
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.