Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT05380167
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2022-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A third party not involved with the conduct of the study provided research staff with the beetroot juice in participant specific coded bottles. The research staff then distributed these coded bottles to the participant. At the end of the trial, the code was revealed for intervention assignment.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into one of two groups. The first group will consume daily beetroot juice containing 380 mg of nitrate and the second group will consume daily beetroot juice with nitrate removed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2022-05-12', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Plasma Nitrate', 'timeFrame': 'Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12', 'description': 'Concentration of nitrate in the plasma obtained at the start of each testing visit'}, {'measure': 'Fasting Plasma Nitrite', 'timeFrame': 'Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12', 'description': 'Concentration of nitrite in the plasma obtained at the start of each testing visit'}, {'measure': '90 minute plasma Nitrate', 'timeFrame': 'Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12', 'description': "Concentration of nitrate in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage"}, {'measure': '90 minute plasma Nitrite', 'timeFrame': 'Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12', 'description': "Concentration of nitrite in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['beetroot juice', 'dietary nitrate', 'plasma nitrite'], 'conditions': ['Cardiovascular Diseases in Old Age']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to determine the chronic effects of beetroot juice supplementation on the acute (90-minute post nitrate consumption) efficacy of converting dietary nitrate to plasma nitrate and plasma nitrite in healthy middle-to-older aged adults. the investigators were also interested in determining the effect of this intervention on fasting levels of plasma nitrate and nitrite over time. Furthermore, the number of participants classified as "non-responders" was determined based on increases in plasma nitrite achieved using tolerable volumes of beetroot juice by other studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Middle and Older (40-80 year-old) men and women\n* Body mass index between 18.5 - 30.0 kg/m2\n* Able to provide own transportation to study testing visits\n* Able to consume study beverages\n* Able to speak and read English\n\nExclusion Criteria:\n\n* Tobacco user (smoke or chew), including e-cigarettes\n* Known conditions of: diabetes mellitus (type 1 or 2), atrophic gastritis, hypo- or hyperthyroidism, gout, history of kidney stones, history of hypotension, cardiovascular disease, chronic obstructive pulmonary disease, inflammatory bowel diseases, impaired liver or kidney function\n* Current or recent (last 3 months) treatment for cancer\n* Current use of the following medications: Phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, medication for hypothyroidism, antacid and heartburn medications'}, 'identificationModule': {'nctId': 'NCT05380167', 'briefTitle': 'Efficacy Long-term Dietary Nitrate Consumption to Plasma Nitrite Conversion', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University'}, 'officialTitle': 'Efficacy and Variability in Plasma Nitrite Levels During Long-term Supplementation With Nitrate Containing Beetroot Juice', 'orgStudyIdInfo': {'id': 'IRB000022922'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BRJ Nitrate', 'description': 'This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 380 mg of nitrate.', 'interventionNames': ['Dietary Supplement: BRJ Nitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'BRJ Placebo', 'description': 'This arm consumed daily for 12 weeks a 70 mL bottle of beetroot juice containing 0 mg of nitrate.', 'interventionNames': ['Dietary Supplement: BRJ Placebo']}], 'interventions': [{'name': 'BRJ Nitrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink with nitrate.', 'armGroupLabels': ['BRJ Nitrate']}, {'name': 'BRJ Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in this group drank daily for 12 weeks a 70 mL bottle of Beet It Sport drink without nitrate', 'armGroupLabels': ['BRJ Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27109', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gary Miller', 'investigatorAffiliation': 'Wake Forest University'}}}}