Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05221905
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2021-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This is a double-blind study, where neither the investigators nor the subjects will know whether the participants are receiving the active supplement or placebo supplement until study conclusion.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subject are stratified randomized to consume either beetroot juice with, or without, inorganic nitrate and will consume this same supplement throughout all testing'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2021-10-14', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline Flow-Mediated Dilation', 'timeFrame': 'Baseline (minute 0).', 'description': 'Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.'}, {'measure': 'Post-Exercise/Control Flow-Mediated Dilation (60 minutes)', 'timeFrame': '60 minutes post-baseline.', 'description': 'Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.'}, {'measure': 'Post-Exercise/Control Flow-Mediated Dilation (90 minutes)', 'timeFrame': '90 minutes post-baseline.', 'description': 'Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.'}, {'measure': 'Post-Exercise/Control Flow-Mediated Dilation (120 minutes)', 'timeFrame': '120 minutes post-baseline.', 'description': 'Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.'}, {'measure': 'Post-Exercise/Control Flow-Mediated Dilation (150 min)', 'timeFrame': '150 minutes post-baseline.', 'description': 'Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.'}, {'measure': 'Post-Exercise/Control Flow-Mediated Dilation (180 min)', 'timeFrame': '180 minutes post-baseline.', 'description': 'Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.'}], 'secondaryOutcomes': [{'measure': 'Baseline Pulse Wave Velocity', 'timeFrame': 'Baseline (minute 0).', 'description': 'Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.'}, {'measure': 'Post-Exercise/Control Pulse Wave Velocity (60 min)', 'timeFrame': '60 minutes post-baseline.', 'description': 'Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.'}, {'measure': 'Post-Exercise/Control Pulse Wave Velocity (90 min)', 'timeFrame': '90 minutes post-baseline.', 'description': 'Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.'}, {'measure': 'Post-Exercise/Control Pulse Wave Velocity (120 min)', 'timeFrame': '120 minutes post-baseline.', 'description': 'Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.'}, {'measure': 'Post-Exercise/Control Pulse Wave Velocity (150 min)', 'timeFrame': '150 minutes post-baseline.', 'description': 'Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.'}, {'measure': 'Post-Exercise/Control Pulse Wave Velocity (180 min)', 'timeFrame': '180 minutes post-baseline.', 'description': 'Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flow-mediated dilation', 'Pulse wave velocity', 'Exercise intensity', 'Vascular function'], 'conditions': ['Vascular Dilation', 'Arterial Stiffness']}, 'descriptionModule': {'briefSummary': 'Post-menopausal females experience elevated cardiovascular disease risk (CVD), compared to premenopausal females and age-matched males. Current exercise guidelines appear inadequate to ameliorate this increased risk and higher intensity exercise may be necessary. Oral inorganic nitrate supplementation enhances both exercise performance and CVD risk profile in several clinical conditions. However, the effects of this intervention in post-menopausal females is unexplored.', 'detailedDescription': 'The purpose of this study is to determine whether acute inorganic nitrate supplementation and exercising at different exercise intensities (high vs moderate) improve vascular health in post-menopausal females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'All subjects are post-menopausal females.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal female, defined as having not had a menstrual cycle for at least 1 year\n* Greater than age 45 but less than age 75\n* Sedentary (does not exercise regularly)\n* No major changes in medication in the last 3 months\n\nExclusion Criteria:\n\n* Smokers within last 5 years\n* Weight unstable (loss/gain of more than 3kg in the past 3 months)\n* Any medical condition that prevents the subject from exercising safely\n* Hormone replacement therapy (current or within last 3 months)\n* Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)\n* Hysterectomy or oophorectomy'}, 'identificationModule': {'nctId': 'NCT05221905', 'briefTitle': 'Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females', 'orgStudyIdInfo': {'id': 'HSR210326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acute High-Intensity Exercise', 'description': 'Subjects will exercise at an intensity of 75% of the difference between the lactate threshold and VO2peak until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.', 'interventionNames': ['Drug: BEET IT - Concentrate Beet root juice', 'Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acute Moderate-Intensity Exercise', 'description': 'Subjects will exercise at an intensity at the lactate threshold until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.', 'interventionNames': ['Drug: BEET IT - Concentrate Beet root juice', 'Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Exercise Control', 'description': 'Measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, without exercise taking place during time points 0-60 min.', 'interventionNames': ['Drug: BEET IT - Concentrate Beet root juice', 'Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)']}], 'interventions': [{'name': 'BEET IT - Concentrate Beet root juice', 'type': 'DRUG', 'otherNames': ['Dietary Nitrate supplementation (nitrate rich)'], 'description': 'Beet It Sport (James White Drinks, Ltd.) each containing 400mg of inorganic nitrate (\\~6.5 mmol) will be consumed twice daily (totalling \\~13 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits.', 'armGroupLabels': ['Acute High-Intensity Exercise', 'Acute Moderate-Intensity Exercise', 'Non-Exercise Control']}, {'name': 'BEET IT - Concentrate Beet root juice (nitrate depleted)', 'type': 'DRUG', 'otherNames': ['Dietary Nitrate supplementation (nitrate depleted)'], 'description': 'Beet It Sport (James White Drinks, Ltd.) each containing 0mg of inorganic nitrate (\\~0 mmol) will be consumed twice daily (totalling \\~0 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. It is provided by the same company that produces the concentrated beet root juice shots (James White Drinks) but the placebo version is nitrate-depleted.', 'armGroupLabels': ['Acute High-Intensity Exercise', 'Acute Moderate-Intensity Exercise', 'Non-Exercise Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Student Health and Wellness Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Arthur Weltman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Kinesiology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'De-identified data will be shared upon reasonable request for 3 years after study completion', 'ipdSharing': 'YES', 'description': 'Microsoft excel sheets, Graphpad Prism files, Informed Consent, and Study Protocol forms will be available upon reasonable request. All identifiable data de-identified on 24 participants will be available.', 'accessCriteria': 'Email Austin Hogwood at ach2jb@virginia.edu for any requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Arthur L Weltman', 'investigatorAffiliation': 'University of Virginia'}}}}