Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT03371966
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2017-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitrate and Exercise Performance in Middle to Older Aged Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2017-12-08', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant Work Rate (CWR) Exercise Time', 'timeFrame': 'Seven days of treatment', 'description': 'Exercise duration measured as the length of the exercise period at a submaximal exercise work rate.'}], 'secondaryOutcomes': [{'measure': 'Isotime Oxygen Consumption (VO2)', 'timeFrame': 'Seven days of treatment', 'description': 'VO2 during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime).'}, {'measure': 'Isotime Borg Rating of Perceived Exertion (RPE)', 'timeFrame': 'Seven days of treatment', 'description': 'RPE during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime).'}, {'measure': 'Isotime Systolic Blood Pressure (Systolic BP)', 'timeFrame': 'Seven days of treatment', 'description': 'Systolic BP during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime).'}, {'measure': 'Isotime Diastolic Blood Pressure (Systolic BP)', 'timeFrame': 'Seven days of treatment', 'description': 'Diastolic BP during the constant work rate exercise test measured at the minimum exercise time from any of the tests (isotime).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Beetroot Juice', 'Older Adults', 'Nitrate', 'Nitrite', 'Nitric Oxide'], 'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '18167491', 'type': 'BACKGROUND', 'citation': 'Lundberg JO, Weitzberg E, Gladwin MT. The nitrate-nitrite-nitric oxide pathway in physiology and therapeutics. Nat Rev Drug Discov. 2008 Feb;7(2):156-67. doi: 10.1038/nrd2466.'}, {'pmid': '17089890', 'type': 'BACKGROUND', 'citation': 'Gladwin MT. Role of the red blood cell in nitric oxide homeostasis and hypoxic vasodilation. Adv Exp Med Biol. 2006;588:189-205. doi: 10.1007/978-0-387-34817-9_17.'}, {'pmid': '19219851', 'type': 'BACKGROUND', 'citation': 'van Faassen EE, Bahrami S, Feelisch M, Hogg N, Kelm M, Kim-Shapiro DB, Kozlov AV, Li H, Lundberg JO, Mason R, Nohl H, Rassaf T, Samouilov A, Slama-Schwok A, Shiva S, Vanin AF, Weitzberg E, Zweier J, Gladwin MT. Nitrite as regulator of hypoxic signaling in mammalian physiology. Med Res Rev. 2009 Sep;29(5):683-741. doi: 10.1002/med.20151.'}, {'pmid': '24791915', 'type': 'BACKGROUND', 'citation': 'Jones AM. Dietary nitrate supplementation and exercise performance. Sports Med. 2014 May;44 Suppl 1(Suppl 1):S35-45. doi: 10.1007/s40279-014-0149-y.'}, {'pmid': '19661447', 'type': 'BACKGROUND', 'citation': 'Bailey SJ, Winyard P, Vanhatalo A, Blackwell JR, Dimenna FJ, Wilkerson DP, Tarr J, Benjamin N, Jones AM. Dietary nitrate supplementation reduces the O2 cost of low-intensity exercise and enhances tolerance to high-intensity exercise in humans. J Appl Physiol (1985). 2009 Oct;107(4):1144-55. doi: 10.1152/japplphysiol.00722.2009. Epub 2009 Aug 6.'}, {'pmid': '21471821', 'type': 'BACKGROUND', 'citation': 'Lansley KE, Winyard PG, Bailey SJ, Vanhatalo A, Wilkerson DP, Blackwell JR, Gilchrist M, Benjamin N, Jones AM. Acute dietary nitrate supplementation improves cycling time trial performance. Med Sci Sports Exerc. 2011 Jun;43(6):1125-31. doi: 10.1249/MSS.0b013e31821597b4.'}, {'pmid': '22248502', 'type': 'BACKGROUND', 'citation': "Cermak NM, Gibala MJ, van Loon LJ. Nitrate supplementation's improvement of 10-km time-trial performance in trained cyclists. Int J Sport Nutr Exerc Metab. 2012 Feb;22(1):64-71. doi: 10.1123/ijsnem.22.1.64."}, {'pmid': '22464802', 'type': 'BACKGROUND', 'citation': 'Miller GD, Marsh AP, Dove RW, Beavers D, Presley T, Helms C, Bechtold E, King SB, Kim-Shapiro D. Plasma nitrate and nitrite are increased by a high-nitrate supplement but not by high-nitrate foods in older adults. Nutr Res. 2012 Mar;32(3):160-8. doi: 10.1016/j.nutres.2012.02.002.'}, {'pmid': '25445634', 'type': 'BACKGROUND', 'citation': 'Berry MJ, Justus NW, Hauser JI, Case AH, Helms CC, Basu S, Rogers Z, Lewis MT, Miller GD. Dietary nitrate supplementation improves exercise performance and decreases blood pressure in COPD patients. Nitric Oxide. 2015 Aug 1;48:22-30. doi: 10.1016/j.niox.2014.10.007. Epub 2014 Oct 27.'}, {'pmid': '26874390', 'type': 'BACKGROUND', 'citation': 'Eggebeen J, Kim-Shapiro DB, Haykowsky M, Morgan TM, Basu S, Brubaker P, Rejeski J, Kitzman DW. One Week of Daily Dosing With Beetroot Juice Improves Submaximal Endurance and Blood Pressure in Older Patients With Heart Failure and Preserved Ejection Fraction. JACC Heart Fail. 2016 Jun;4(6):428-37. doi: 10.1016/j.jchf.2015.12.013. Epub 2016 Feb 10.'}, {'pmid': '32574223', 'type': 'DERIVED', 'citation': 'Berry MJ, Miller GD, Kim-Shapiro DB, Fletcher MS, Jones CG, Gauthier ZD, Collins SL, Basu S, Heinrich TM. A randomized controlled trial of nitrate supplementation in well-trained middle and older-aged adults. PLoS One. 2020 Jun 23;15(6):e0235047. doi: 10.1371/journal.pone.0235047. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Research with young healthy individuals has shown that beetroot juice beverages that contain large amounts of nitrate can improve exercise performance. Currently, it is not know whether the consumption of beetroot juice beverages high in nitrate can improve exercise performance in higher functioning middle- to older-aged adults. Therefore, the purpose of this study is to compare the effect of two different beetroot juice beverages (one high in nitrate and one low in nitrate) on exercise performance in middle- to older-aged adults.', 'detailedDescription': 'Nitric oxide (NO) has been identified as an important biological messenger involved in a number of physiological processes and is produced from L-arginine and molecular oxygen by NO-synthases or the more recently identified nitrate to nitrite to NO pathway. Dietary nitrate can be found in green leafy vegetables and is particularly abundant in beetroot and has been shown to be a potential ergogenic agent. The nitrate to nitrite to NO pathway has been shown to be involved in a number of physiological processes that could account for the improved exercise response following nitrate ingestion. However, the benefits of nitrate as an ergogenic aid have been shown to be effected by numerous factors that can influence its efficacy. These include age, training level, dosage and the mode, duration and intensity of the exercise.\n\nResearch with healthy younger moderately trained adults has repeatedly shown that ingestion of dietary nitrate can reduce the oxygen cost of submaximal exercise and improve exercise performance during high intensity exercise; whereas research with younger more highly trained endurance athletes is equivocal, since some studies have failed to demonstrate an improvement in exercise performance following nitrate ingestion.\n\nThe effects of nitrate have also been shown to be influenced by age. It has been documented that there are alterations in NO metabolism in older adults thought to result from impairment of the NO-synthases pathway. The investigators have shown that consumption of a supplement high in nitrate, such as beetroot juice, leads to elevated plasma nitrite levels and may help restore NO metabolism in older adults; whereas a diet high in nitrate without supplementation was insufficient at increasing plasma nitrite levels. The investigators research, along with that of others has shown nitrate supplementation to have positive effects in older adults with chronic diseases. However, research examining the effects of dietary nitrate on exercise performance in healthy older adults is scarce. Presently, it is unclear as to whether nitrate supplementation is beneficial to exercise performance in older adults and there is no data examining the effect of nitrate supplementation on exercise performance in active older adults. Therefore, the purpose of this study is to examine the effect of chronic nitrate supplementation on exercise performance in active higher functioning older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Competitive runner or cyclist.\n* Able to pedal a stationary bike.\n* Engage in moderate physical activity for at least 150 minutes per week or engage in strenuous physical activity for at least 75 minutes per week.\n* Able to provide own transportation to study testing visits.\n* Able to provide own transportation to study testing visits.\n* Able to consume study beverages.\n* Willingness to provide informed consent and participate in the intervention.\n\nExclusion Criteria:\n\n* tobacco user (smoke or chew)\n* participating in another intervention research study\n* diabetes (type 1 or 2)\n* atrophic gastritis\n* hypo-or hyperthyroidism\n* gout\n* history of kidney stones\n* history of hypotension\n* aversion to the study-related testing procedures\n* allergy/sensitivity/aversion to beetroot beverages\n* medical conditions with contraindications for engaging in the vigorous aerobic exercise\n* current treatment for cancer\n* thyroid disorders,\n* cardiovascular disease,\n* chronic obstructive pulmonary disease,\n* inflammatory bowel diseases\n* impaired liver or kidney function\n* taking phosphodiesterase type 5 inhibitors\n* taking nitroglycerin or nitrate preparations\n* taking proton pump inhibitors\n* taking medication for hypothyroidism'}, 'identificationModule': {'nctId': 'NCT03371966', 'briefTitle': 'Nitrate and Exercise Performance in Middle to Older Aged Adults', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University'}, 'officialTitle': 'The Effects of Chronic Dietary Nitrate Supplementation on Constant Work Rate Exercise in High Functioning Middle Aged and Older Adults', 'orgStudyIdInfo': {'id': 'WFU-IRB00022914'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Nitrate Beetroot Juice', 'description': 'Beetroot juice high in nitrate will contain approximately 10.0 mmole nitrate per 120 ml.', 'interventionNames': ['Dietary Supplement: High Nitrate Beetroot Juice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low Nitrate Beetroot Juice', 'description': 'Beetroot juice low in nitrate will contain approximately 0.5 mmole nitrate per 120 ml.', 'interventionNames': ['Dietary Supplement: Low Nitrate Beetroot Juice']}], 'interventions': [{'name': 'High Nitrate Beetroot Juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High nitrate beetroot juice (120 ml) will be administered for 7 days consecutively followed by a 7 day washout period then 7 consecutive days of low nitrate beetroot juice.', 'armGroupLabels': ['High Nitrate Beetroot Juice']}, {'name': 'Low Nitrate Beetroot Juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low nitrate beetroot juice (120 ml) will be administered for 7 days consecutively followed by a 7 day washout period then 7 consecutive days of high nitrate beetroot juice..', 'armGroupLabels': ['Low Nitrate Beetroot Juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27109', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Michael H Berry, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Isagenix International LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}