Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-27 @ 1:00 AM
Study NCT ID:
NCT03806868
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intervention Increasing Omega-3 Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum omega 3 levels', 'timeFrame': 'Baseline, 2 weeks and 4 weeks', 'description': 'Omega 3 levels in serum (mg) will be measured at each study visit.'}, {'measure': 'Change in omega 3 intake', 'timeFrame': 'Baseline and 4 weeks', 'description': 'A food frequency questionnaire will be administered at baseline and 4 weeks after randomization to estimate omega 3 intake (mg) at each study visit'}], 'secondaryOutcomes': [{'measure': 'Change in health status as assessed by the Clinical COPD Questionnaire (CCQ)', 'timeFrame': 'Baseline, 2 weeks and 4 weeks', 'description': 'The CCQ is a validated score to assess health status in COPD subjects. Score ranges from 0 to 6. The higher the score indicates lower health status.'}, {'measure': 'Change in the Cough and Sputum Assessment Questionnaire (CASA-Q) Score', 'timeFrame': 'Baseline, 2 weeks and 4 weeks', 'description': 'The CASA-Q will be administered at each study visit. Total score ranges from 0 to 100, with higher scores associated with fewer symptoms/less impact due to cough or sputum.'}, {'measure': 'Change in Functional status (CAT)', 'timeFrame': 'Baseline, 2 weeks and 4 weeks', 'description': 'Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control'}, {'measure': 'Change in FEV1 percentage predicted', 'timeFrame': 'Baseline, 2 weeks and 4 weeks', 'description': 'Pulmonary function testing will be assessed as FEV1 percentage predicted, that is FEV1, adjusted for age, height, race and sex.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This Dietary Intervention is being done to evaluate the feasibility of a food voucher program and dietary counseling to increase consumption of healthy fatty acids (omega-3) in individuals with Chronic Obstructive Pulmonary Disease (COPD).', 'detailedDescription': "The goal of this pilot intervention is to evaluate the feasibility of a food voucher program and dietary counseling to increase dietary intake of omega-3 fatty acid in individuals with COPD.\n\nThis hypothesis is based on a number of recent observations. Studies have investigated the impact of omega-3 fatty acids, especially Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA), alfa-linolenic acid (ALA) intake in chronic diseases and show a link with decreased systemic inflammation measured by cytokines including interleukin 1 (IL-1B), interleukin 6 (IL-6), interleukin 10 (IL-10), tumoral necrosis factor alfa (TNF-α) and eicosanoids; and improved outcomes. In a large cross-sectional study of individuals with COPD, a diet rich in the omega-3 ALA was associated with lower serum TNF-α levels while a diet rich in the omega-6's LA and arachidonic acid (AA) had higher systemic inflammatory markers IL-6 and c-reactive protein (CRP). Other recent nutritional epidemiological study showed the association of greater intakes of omega-3 fatty acids with better lung function profile, but also a slower forced expiratory volume at the 1 second (FEV1) decline in the same smoker cohort.\n\nPreliminary cross-sectional data (n=59), from the CLEAN Air study, reported that at baseline, a higher omega 3 dietary intake was linked with reduced systemic inflammation (IL-1B) and improved respiratory outcomes (a 28% decrease in the odds of COPD symptoms in moderate-severe COPD and conversely, higher omega-6 levels associated with worse outcomes, including increased dyspnea and lower lung function. These findings support the importance of implementing an intervention program to confirm there is a beneficial association between fatty acid dietary intake and reduced COPD symptoms.\n\nTo this end, the investigators propose a pilot intervention study in 20 subjects to see if the investigators can increase omega-3 dietary intake over a 4 week period. The investigators will measure self-report dietary intake of omega 3 and 6 fatty acids, as well as measure, fasting plasma fatty acid levels, before and after the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 40 years,\n* Physician diagnosis of COPD, Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced -Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) \\<70% and FEV1 (% predicted) \\<80%,\n* Tobacco exposure ≥ 10 pack-years\n* Former smoker with an exhaled Carbon Monoxide (eCO)\\<=6 ppm to confirm smoking status\n* No home smoking ban.\n* Subjects with low omega-3 intake (EPA+DHA levels \\<500mg) based on data extracted from a food frequency questionnaire (FFQ) completed before the randomization.\n\nExclusion Criteria:\n\n* Chronic systemic corticosteroids,\n* Other chronic lung disease including asthma,\n* Living in location other than home (e.g., long term care facility)\n* Homeowner or occupant planning to move or change residence within study period.'}, 'identificationModule': {'nctId': 'NCT03806868', 'briefTitle': 'Dietary Intervention Increasing Omega-3 Intake', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Dietary Intervention Increasing Omega-3 Intake- Feasibility Trial', 'orgStudyIdInfo': {'id': 'IRB00069904'}, 'secondaryIdInfos': [{'id': 'P50MD010431', 'link': 'https://reporter.nih.gov/quickSearch/P50MD010431', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'The Intervention group will receive a voucher for ordering foods (ONLY omega-3 rich foods) weekly (4 times).', 'interventionNames': ['Other: voucher for ordering foods (ONLY omega-3 rich foods)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'The Control group will receive a voucher for ordering foods in general (any type of foods) weekly (4 times). Participants will NOT be limited to purchasing foods rich in omega-3.', 'interventionNames': ['Other: voucher for ordering foods in general (any type of foods)']}], 'interventions': [{'name': 'voucher for ordering foods (ONLY omega-3 rich foods)', 'type': 'OTHER', 'description': "A voucher will be provided weekly (4 times) for ordering only omega-3 rich foods. Groceries will be delivered to participants' home weekly.", 'armGroupLabels': ['Intervention group']}, {'name': 'voucher for ordering foods in general (any type of foods)', 'type': 'OTHER', 'description': "A voucher will be provided weekly (4 times) for ordering any type of food. Groceries will be delivered to participants' home weekly.", 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Campus', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'NADIA NATHALIE HANSEL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}