Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-04-17 @ 12:35 AM
Study NCT ID:
NCT02223403
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2014-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'steady state exercise oxygen consumption', 'timeFrame': '10 minutes', 'description': 'Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.'}, {'measure': 'six minute walk distance', 'timeFrame': 'six minutes', 'description': 'subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nitrate-rich beetroot juice', 'heart failure', 'exercise performance', 'oxygen consumption'], 'conditions': ['Systolic Heart Failure']}, 'descriptionModule': {'briefSummary': 'Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and submaximal exercise performance in healthy adults. Investigation for similar effects in patients with heart failure has not previously been conducted.\n\nThis was a randomized, double-blind, placebo controlled trial. Following ingestion of the active agent or placebo, subjects with systolic heart failure underwent submaximal steady state exercise with gas exchange analysis followed thirty minutes later by a six minute walk test. Second testing sessions were performed ten days.\n\nThere were no significant differences in the treatment and placebo arms in average oxygen consumption or six minute walk distance.\n\nIn conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich beetroot juice concentrate, there is no significant difference with regard to oxygen consumption during submaximal steady state exercise or six minute walk testing distance.\n\nFurther study is warranted to determine the true efficacy of nitrate consumption in this population with adjustments in acute or chronic dosing, exercise duration, or intensity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Local institutional beneficiaries between the ages of 18 and 80\n* Documentation of left ventricular systolic dysfunction with ejection fraction \\< 40% by any modality within the past six months\n* Documentation of New York Heart Association class II or III status.\n\nExclusion Criteria:\n\n* \\> 80 years of age\n* Unable to adequately or safely perform treadmill exercise\n* Pulmonary disease deemed significant enough to be a limitation to exercise\n* Greater than moderate stenotic or regurgitant valvular heart disease\n* Presence of atrial fibrillation or other uncontrolled arrhythmias\n* Uncompensated heart failure\n* Continuously paced rhythms\n* Pregnant females\n* Chronic nitroglycerine use (oral isosorbide di or mono-nitrate, or topical nitroglycerine)\n* Phosphodiesterase inhibitor (sildenafil or tadalafil) use within a week'}, 'identificationModule': {'nctId': 'NCT02223403', 'briefTitle': 'Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients', 'organization': {'class': 'FED', 'fullName': 'Brooke Army Medical Center'}, 'officialTitle': 'Single Dose of Nitrate-rich Beetroot Juice Does Not Improve Steady State Oxygen Consumption or Six-minute Walk Distance in Patients With Systolic Heart Failure.', 'orgStudyIdInfo': {'id': '383967-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'submaximal steady state exercise', 'description': '90 minutes after respective beetroot juice ingestion, subjects walked on treadmill at a pre-determined steady state workload for a total of 15 minutes with oxygen consumption recorded for the last 10 minutes', 'interventionNames': ['Dietary Supplement: nitrate-rich beetroot juice', 'Dietary Supplement: nitrate-deplete beetroot juice']}, {'type': 'EXPERIMENTAL', 'label': 'six minute walk test', 'description': 'subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed', 'interventionNames': ['Dietary Supplement: nitrate-rich beetroot juice', 'Dietary Supplement: nitrate-deplete beetroot juice']}], 'interventions': [{'name': 'nitrate-rich beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beet It Sport Stamina Shot'], 'description': '3 ounces of nitrate-rich beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk', 'armGroupLabels': ['six minute walk test', 'submaximal steady state exercise']}, {'name': 'nitrate-deplete beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beet It Sport Stamina Shot'], 'description': '3 ounces of nitrate-deplete beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk', 'armGroupLabels': ['six minute walk test', 'submaximal steady state exercise']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kenneth M Leclerc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brooke Army Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brooke Army Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Kenneth M Leclerc', 'investigatorAffiliation': 'Brooke Army Medical Center'}}}}