Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-19 @ 7:49 PM
Study NCT ID:
NCT02084758
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2014-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2014-02-17', 'studyFirstSubmitQcDate': '2014-03-10', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'VO2max and Wmax', 'timeFrame': 'Baseline'}, {'measure': 'height, body weight and body mass index (BMI)', 'timeFrame': 'Baseline'}, {'measure': 'Fat free mass and fat mass', 'timeFrame': 'Baseline', 'description': 'Fat free mass and fat mass determined by DEXA-scan'}, {'measure': 'Lung function', 'timeFrame': 'Baseline'}, {'measure': 'Physical activity', 'timeFrame': 'During the two supplementation periods'}], 'primaryOutcomes': [{'measure': 'Change in metabolic efficiency during exercise', 'timeFrame': 'Baseline, day 7, day 14 and day 21.', 'description': 'Metabolic efficiency (degree of efficiently used energy during exercise) will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change in blood pressure during exercise', 'timeFrame': 'Baseline, day 7, day 14 and day 21.', 'description': 'Change in blood pressure will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.'}, {'measure': 'Change in dyspnea during exercise', 'timeFrame': 'Baseline, day 7, day 14 and day 21.', 'description': 'Change in dyspnea will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.'}, {'measure': 'Change in cycle endurance time during exercise.', 'timeFrame': 'Baseline, day 7, day 14 and day 21.', 'description': 'Change in cycle endurance time will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.'}, {'measure': 'Change in oxygen uptake (VO2 mL/min) during exercise', 'timeFrame': 'Baseline, day 7, day 14 and day 21', 'description': 'Change in oxygen uptake will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.'}, {'measure': 'Change in Resting Energy Expenditure (REE)', 'timeFrame': 'Baseline, day 7, day 14 and day 21', 'description': 'Change in REE will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.'}, {'measure': 'Change in plasma concentrations of nitrate and nitrite, glucose, insulin, lactate and free fatty acids, IFABP and cardiac troponin', 'timeFrame': 'Baseline, day 7, day 14 and day 21', 'description': 'Change in these plasma concentrations will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'nitrate supplementation', 'metabolic efficiency'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate solution) and the placebo, separated by a 1 wk washout period. The investigators will test the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic efficiency in patients with COPD compared to the placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD\n* Indication metabolic inefficiency\n\nExclusion Criteria:\n\n* Sodium intake limitation\n* Long-term oxygen therapy\n* Severe renal impairment\n* Use of medications that may interact with nitrate\n* Contra-indications for performing (sub)maximal cycle ergometry'}, 'identificationModule': {'nctId': 'NCT02084758', 'briefTitle': 'Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD', 'orgStudyIdInfo': {'id': 'ABR-47701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nitrate supplementation', 'description': 'Sodium nitrate solution', 'interventionNames': ['Dietary Supplement: Nitrate supplementation', 'Dietary Supplement: Placebo supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo supplementation', 'description': 'Sodium chloride solution', 'interventionNames': ['Dietary Supplement: Nitrate supplementation', 'Dietary Supplement: Placebo supplementation']}], 'interventions': [{'name': 'Nitrate supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': '7 days of supplementation with sodium nitrate solution', 'armGroupLabels': ['Nitrate supplementation', 'Placebo supplementation']}, {'name': 'Placebo supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': '7 days of supplementation with sodium chloride solution', 'armGroupLabels': ['Nitrate supplementation', 'Placebo supplementation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Annemie Schols, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}