Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-20 @ 11:12 AM
Study NCT ID:
NCT03251157
Status:
COMPLETED
Last Update Posted:
2017-08-16
First Post:
2017-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intake in Adults From the GA2LEN Folow-up Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Participants had serum taken which was stored frozen and subsequently analysed in a central laboratory to estimate concentration of several biomarkers including hormones (e.g. leptin), markers of inflammation (cytokines CRP, Interleukin 6 (IL-6), Interleukin 8 (IL-8), Tumour Necrosis Factor alpha (TNF-α) Transforming Growth Factor beta (TGF-β) and Myeloperoxidase (MPO)), and serum levels of total and allergen-specific IgEs.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-15', 'studyFirstSubmitDate': '2017-08-12', 'studyFirstSubmitQcDate': '2017-08-15', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Asthma', 'timeFrame': 'Last 12 months', 'description': 'Asthma was defined as a history of ever having asthma and reporting at least one of the following symptoms in the last 12 months: wheeze or whistling in the chest, waking with chest tightness, waking with shortness of breath, and waking with an attack of coughing'}, {'measure': 'IgE sensitisation', 'timeFrame': '1 day', 'description': 'Serum concentrations of total IgE (geometric mean) were estimated'}], 'primaryOutcomes': [{'measure': 'Asthma score', 'timeFrame': 'Last 12 months', 'description': 'Five questions on symptoms in the last 12 months (breathless when wheezing, woken with tightness in chest, shortness of breath while at rest, shortness of breath after exercise, woken by shortness of breath) were used to construct an asthma symptom score on a five-point scale'}, {'measure': 'Chronic rhinosinusitis (CRS)', 'timeFrame': 'Last 12 weeks', 'description': 'defined following the EP3OS criteria, that is, the presence of at least two of the following symptoms for at least 12 weeks in the past year: (i) nasal blockage, (ii) nasal discharge, (iii) facial pain or pressure or (iv) reduction in sense of smell with at least one of the symptoms being nasal blockage or nasal discharge'}, {'measure': 'Lung function', 'timeFrame': 'Day', 'description': 'Spirometric lung function (Forced Expiratory Volume in one second (FEV1), and Forced Vital Capacity (FVC)) were measured pre- and post- administration of bronchodilator (salbutamol 200 mg). Spirometric restriction was defined by an FVC below the limit of normal, chronic obstruction by an FEV1/FVC below the limit of normal. All spirometries were checked centrally for quality. Only spirometry that met the ERS/ATS criteria was accepted'}, {'measure': 'Atopy', 'timeFrame': '1 day', 'description': 'Skin prick tests (SPTs) to grass pollen, grass mix, Dermatophagoides pteronyssinus, Dermatophagoides farinae, cockroach (Blatella), olive, Alternaria, dog, Artemisia, birch, cat and Parietaria were conducted. A SPT was regarded as positive where the allergen weal was \\>1 mm more than the diluent control. Atopy was defined as any positive response to any of the allergens tested'}, {'measure': 'Allergic rhinitis', 'timeFrame': 'Last month', 'description': "Defined based on a positive answer to the question 'Do you have any nasal allergies or hay fever'?"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Adults', 'Europe', 'Lung function', 'Allergy', 'Atopy', 'IgE', 'Sensitisation', 'Diet', 'Dietary patterns', 'Dietary antioxidants', 'Flavonoids', 'Fruits and vegetables', 'Food frequency questionnaire (FFQ)', 'Fatty acids'], 'conditions': ['Asthma', 'Lung Function Decreased', 'Food Allergy', 'Allergic Sensitisation', 'Allergic Rhinitis', 'COPD', 'Atopy']}, 'referencesModule': {'references': [{'pmid': '19392994', 'type': 'BACKGROUND', 'citation': "Bousquet J, Burney PG, Zuberbier T, Cauwenberge PV, Akdis CA, Bindslev-Jensen C, Bonini S, Fokkens WJ, Kauffmann F, Kowalski ML, Lodrup-Carlsen K, Mullol J, Nizankowska-Mogilnicka E, Papadopoulos N, Toskala E, Wickman M, Anto J, Auvergne N, Bachert C, Bousquet PJ, Brunekreef B, Canonica GW, Carlsen KH, Gjomarkaj M, Haahtela T, Howarth P, Lenzen G, Lotvall J, Radon K, Ring J, Salapatas M, Schunemann HJ, Szczecklik A, Todo-Bom A, Valovirta E, von Mutius E, Zock JP. GA2LEN (Global Allergy and Asthma European Network) addresses the allergy and asthma 'epidemic'. Allergy. 2009 Jul;64(7):969-77. doi: 10.1111/j.1398-9995.2009.02059.x. Epub 2009 Apr 7."}, {'pmid': '28149501', 'type': 'BACKGROUND', 'citation': 'Garcia-Larsen V, Arthur R, Potts JF, Howarth PH, Ahlstrom M, Haahtela T, Loureiro C, Bom AT, Brozek G, Makowska J, Kowalski ML, Thilsing T, Keil T, Matricardi PM, Toren K, van Zele T, Bachert C, Rymarczyk B, Janson C, Forsberg B, Nizankowska-Mogilnicka E, Burney PGJ. Is fruit and vegetable intake associated with asthma or chronic rhino-sinusitis in European adults? Results from the Global Allergy and Asthma Network of Excellence (GA2LEN) Survey. Clin Transl Allergy. 2017 Jan 27;7:3. doi: 10.1186/s13601-016-0140-9. eCollection 2017.'}, {'pmid': '21427744', 'type': 'BACKGROUND', 'citation': "Garcia-Larsen V, Luczynska M, Kowalski ML, Voutilainen H, Ahlstrom M, Haahtela T, Toskala E, Bockelbrink A, Lee HH, Vassilopoulou E, Papadopoulos NG, Ramalho R, Moreira A, Delgado L, Castel-Branco MG, Calder PC, Childs CE, Bakolis I, Hooper R, Burney PG; GA2LEN-WP 1.2 'Epidemiological and Clinical Studies'. Use of a common food frequency questionnaire (FFQ) to assess dietary patterns and their relation to allergy and asthma in Europe: pilot study of the GA2LEN FFQ. Eur J Clin Nutr. 2011 Jun;65(6):750-6. doi: 10.1038/ejcn.2011.15. Epub 2011 Mar 23."}]}, 'descriptionModule': {'briefSummary': 'The Nutrition Study of the GA2LEN Follow-Survey was designed to investigate the association between usual dietary intake and allergic and respiratory outcomes in adults across Europe. Within this framework, a food frequency questionnaire (FFQ) was designed to ascertain usual dietary intake of 250 food items, which was translated into the languages of the participant centres. Information on daily intake of foods, nutrients, and flavonoids was derived.', 'detailedDescription': "Within the GA2LEN Follow-up Survey, the Nutrition Survey was aimed at assessing dietary intake in adults across European countries and its association with various outcomes of allergy and respiratory health. In absence of an internationally comparable dietary questionnaire to ascertain usual dietary intake, a single and standardized food frequency questionnaire (FFQ) was design to be used as a common instrument in all participant countries. The FFQ is comprised of 32 food sections and 250 food items. The FFQ sections were designed following the recommendations by the EFCOSUM Group, which facilitate international comparisons of dietary intake. It also included several staple foods to capture locally representative dietary intake.\n\nParticipants reported how often they had consumed each of the foods over the previous month, using eight predefined options (rarely or never, 1-3 times per month, once, 2-4, or 5-6 times per week, once, 2-3 times per day). Standard food portion sizes were used to quantify the intake following the recommendations from the UK's Food Standards Agency. Daily intake of foods (g) were estimated and macro- and micronutrient and flavonoid intakes were derived. The GA2LEN FFQ was validated in five EU countries, namely Finland, UK, Portugal, Germany, Poland, and Greece, and demonstrated to be a good tool to assess mid-term intake of foods, specifically essential polyunsaturated fatty acids (PUFAs). The instrument has also been demonstrated to be an accurate tool to assess dietary sources of flavonoids.\n\nVarious approaches were planned to derive dietary exposures and to examine their association with respiratory and allergic outcomes. These included the use of dietary patterns derived from Principal Component Analysis (PCA), a dietary inflammatory index (DII), as well as single antioxidants, and individual food items."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The GA2LEN follow-up study was a multi-center case-control study with participants selected from the respondents to an initial cross-sectional survey of a general population of adults aged 15-74 years living in 17 European cities and completed between June 2007 and May 2009. A random sample of eligible participants who indicated a willingness to be re-contacted was selected based on their responses to the initial postal survey. The cases were participants who either had asthma, sinusitis or both and the controls (who lived in the same areas) were those who reported having neither. Each center recruited up to 120 cases each of patients with asthma only, CRS only, controls and 40 patients with both asthma and CRS based on the responses to the initial cross-sectional survey.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants aged 15-75 years old, who had responded to the GA2LEN Baseline survey and who met the definition of cases or controls (as described below)\n\nExclusion Criteria:\n\nParticipants who did not answer the baseline survey'}, 'identificationModule': {'nctId': 'NCT03251157', 'briefTitle': 'Dietary Intake in Adults From the GA2LEN Folow-up Survey', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Dietary Intake, Allergy and Respiratory Diseases in European Adults From the GA2LEN Follow-up Survey', 'orgStudyIdInfo': {'id': 'GA2LEN Nutrition Survey'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dietary intake of various nutrients, foods and biocompounds', 'type': 'OTHER', 'description': 'Participants answered a self-administered FFQ, in which they reported the usual frequency of intake of a list of 250 food items'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bloomberg School of Public Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Peter GJ Burney, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Queries on IPD from the GA2LEN Nutrition Survey may be sent to the study Principal Investigator Dr Vanessa Garcia Larsen (vgla@jhu.edu) or to the study Chair Professor Peter GJ Burney (p.burney@imperial.ac.uk)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}, {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Medical University of Lodz', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'University Ghent', 'class': 'OTHER'}, {'name': 'University of Wuerzburg', 'class': 'OTHER'}, {'name': 'Medical University of Silesia', 'class': 'OTHER'}, {'name': 'University of Coimbra', 'class': 'OTHER'}, {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'Uppsala University', 'class': 'OTHER'}, {'name': 'Umeå University', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'University of Southampton', 'class': 'OTHER'}, {'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'Jagiellonian University', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Human Nutrition', 'investigatorFullName': 'Vanessa Larsen', 'investigatorAffiliation': 'Johns Hopkins Bloomberg School of Public Health'}}}}