Clinical trial NCT05221905: Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
Official title: Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vascular Dilation
Arterial Stiffness
Keywords: Flow-mediated dilation
Pulse wave velocity
Exercise intensity
Vascular function
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 24
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subject are stratified randomized to consume either beetroot juice with, or without, inorganic nitrate and will consume this same supplement throughout all testing
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Post-menopausal female, defined as having not had a menstrual cycle for at least 1 year
* Greater than age 45 but less than age 75
* Sedentary (does not exercise regularly)
* No major changes in medication in the last 3 months

Exclusion Criteria:

* Smokers within last 5 years
* Weight unstable (loss/gain of more than 3kg in the past 3 months)
* Any medical condition that prevents the subject from exercising safely
* Hormone replacement therapy (current or within last 3 months)
* 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.)
* Hysterectomy or oophorectomy

Primary outcomes:
measure: Baseline Flow-Mediated Dilation
timeFrame: Baseline (minute 0).
measure: Post-Exercise/Control Flow-Mediated Dilation (60 minutes)
timeFrame: 60 minutes post-baseline.
measure: Post-Exercise/Control Flow-Mediated Dilation (90 minutes)
timeFrame: 90 minutes post-baseline.
measure: Post-Exercise/Control Flow-Mediated Dilation (120 minutes)
timeFrame: 120 minutes post-baseline.
measure: Post-Exercise/Control Flow-Mediated Dilation (150 min)
timeFrame: 150 minutes post-baseline.
measure: Post-Exercise/Control Flow-Mediated Dilation (180 min)
timeFrame: 180 minutes post-baseline.
Secondary outcomes:
measure: Baseline Pulse Wave Velocity
timeFrame: Baseline (minute 0).
measure: Post-Exercise/Control Pulse Wave Velocity (60 min)
timeFrame: 60 minutes post-baseline.
measure: Post-Exercise/Control Pulse Wave Velocity (90 min)
timeFrame: 90 minutes post-baseline.
measure: Post-Exercise/Control Pulse Wave Velocity (120 min)
timeFrame: 120 minutes post-baseline.
measure: Post-Exercise/Control Pulse Wave Velocity (150 min)
timeFrame: 150 minutes post-baseline.
measure: Post-Exercise/Control Pulse Wave Velocity (180 min)
timeFrame: 180 minutes post-baseline.
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: Student Health and Wellness Center
state: Virginia
Study officials:
affiliation: Professor of Kinesiology
name: Arthur Weltman, PhD
role: PRINCIPAL_INVESTIGATOR
References: