Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-03-05 @ 12:22 PM
Study NCT ID:
NCT03189251
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2017-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HFCS, Apple Juice, Excess Free Fructose & asthma-the FHS-OS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004435', 'term': 'Eating'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2657}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1971-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'lastUpdateSubmitDate': '2017-06-14', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma', 'timeFrame': 'Exams 3 - 7, 17 years of follow-up', 'description': 'Incident asthma defined as self-reported asthma (at each exam), including wheezing or asthma (have you had asthma/ wheeze since the last exam of short duration, long duration or with respiratory infections)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Perform an exploratory analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice) and Chronic Bronchitis (CB)/history of CB, and asthma/ history of asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in the Framingham Heart Study (Offspring) cohort', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants in the FHS Offspring who answered questions in the FFQ about soft drinks, fruit drinks and fruit juice consumption; Participants with non-missing data for the exposures and potentially confounding variables of interest.\n\nExclusion Criteria:\n\n* Extreme energy intake on food frequency questionnaire (defined as ≤600 kcal/day or ≥4800 kcal/day)'}, 'identificationModule': {'nctId': 'NCT03189251', 'briefTitle': 'HFCS, Apple Juice, Excess Free Fructose & asthma-the FHS-OS', 'organization': {'class': 'INDIV', 'fullName': 'DeChristopher, Luanne R.'}, 'officialTitle': 'Moderate Intake of High Fructose Corn Syrup Sweetened Soft Drinks, Fruit Drinks and Apple Juice Increases Asthma Risk - the Framingham Offspring Cohort', 'orgStudyIdInfo': {'id': 'EFF, HFCS, asthma-the FHS-OS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dietary intakes', 'type': 'OTHER', 'description': 'Analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luanne R DeChristopher', 'class': 'INDIV'}, 'collaborators': [{'name': 'Jaime Uribarri, M.D.', 'class': 'UNKNOWN'}, {'name': 'Katherine L. Tucker, Ph.D.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Independent Researcher', 'investigatorFullName': 'Luanne R DeChristopher', 'investigatorAffiliation': 'DeChristopher, Luanne R.'}}}}