Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-04-11 @ 5:14 AM
Study NCT ID:
NCT02999503
Status:
UNKNOWN
Last Update Posted:
2016-12-21
First Post:
2016-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attention Deficit Hyperactivity Disorder: Nutrition and Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-20', 'lastUpdatePostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Conners', 'timeFrame': 'At 3 and 6 months', 'description': 'Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type.'}], 'secondaryOutcomes': [{'measure': 'Change in sleep', 'timeFrame': 'At 3 and 6 months', 'description': 'Markers related to sleep: adapted Short Form Health Survey-36 for sleep quality.'}, {'measure': 'Change in exercise markers', 'timeFrame': 'At 3 and 6 months', 'description': 'Markers related to activity: Ipad-Minnesota questionnaire for physical activity.'}, {'measure': 'Change in Anthropometry I', 'timeFrame': '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', 'timeFrame': 'At 3 and 6 months', 'description': 'BMI, calculated using height and weight.'}, {'measure': 'Change in Anthropometry III', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': 'At 3 and 6 months', 'description': 'Kidmed ( mediterranean diet adherence) questionnaire at baseline, 3 and 6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adhd treatment', 'nutrition'], 'conditions': ['ADHD', 'Lifestyle-Related Condition', 'Food Habits']}, 'referencesModule': {'references': [{'pmid': '37058600', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nMeta-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\n\nFOOD, NUTRITION AND ADHD: A NEW PARADIGM OF THERAPY?\n\nDespite 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.\n\nThe 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.\n\nMultiple 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.\n\nOBJECTIVES\n\n* Main objective:\n\n * Rating, by analysis of results, environmental, nutritional and body composition factors, which may affect the pathogenesis and symptoms of ADHD patients.\n* Specific objectives (project sub-lines):\n\n * 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.\n * 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.\n * Body Composition: assessing body fat accumulation and muscle mass, aspects involved in the metabolism of people with ADHD.\n\nDESIGN\n\nCross-sectional study of observational, descriptive and comparative cohort. It consists of volunteer participants, divided into two study groups:\n\n1. cases (ADHD) and\n2. controls (healthy, with no ADHD).\n\nFor the initial design and protocols main databases have been revised (Scielo, PubMed, ENBASE...).\n\nDevelopment: An observational retrospective cohort study.\n\nIncidental sample: n = 70-100 (approximately 35-50 subjects per group, of the same age range).\n\nInclusion criteria: both genders, ages 8-16 years.\n\nIntervention 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* Ages 8-16 years\n* ADHD proved\n\nExclusion Criteria:\n\n* Presence of serious or chronic illnesses: leukemia, spinal cord injury, celiac disease, pancreatitis, hepatitis, HIV...'}, 'identificationModule': {'nctId': 'NCT02999503', 'briefTitle': 'Attention Deficit Hyperactivity Disorder: Nutrition and Environment', 'organization': {'class': 'OTHER', 'fullName': 'Hospital El Escorial'}, 'officialTitle': 'Nutritional and Environmental Conditions in Attention Deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'CINUSA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional intervention', 'description': 'Patients subject to nutritional education by CINUSA group protocol', 'interventionNames': ['Behavioral: Nutritional education']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Patients not subject to nutritional education'}], 'interventions': [{'name': 'Nutritional education', 'type': 'BEHAVIORAL', 'description': 'Nutritional education trough a personal online nutritional consultant', 'armGroupLabels': ['Nutritional intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28200', 'city': 'El Escorial', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'javier andres BLumenfeld Olivares', 'role': 'CONTACT', 'email': 'javierandres.blumenfeld@salud.madrid.org'}], 'facility': 'Hospital EL Escorial', 'geoPoint': {'lat': 40.59144, 'lon': -4.14738}}], 'centralContacts': [{'name': 'Javier Andrés Blumenfeld Olivares, MD', 'role': 'CONTACT', 'email': 'javierandres.blumenfeld@salud.madrid.org', 'phone': '+34625284294'}, {'name': 'Ismael San Mauro Martin, PhD', 'role': 'CONTACT', 'email': 'isma182@hotmail.com'}], 'overallOfficials': [{'name': 'Javier Andres Blumenfeld Olivares, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital El Escoral'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital El Escorial', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatrician, Responsible of Pediatric Endocrinology. Principal Investigator.', 'investigatorFullName': 'Blumenfeld Olivares JA', 'investigatorAffiliation': 'Hospital El Escorial'}}}}