Clinical trial NCT06480695: Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females
Official title: Effects of Exercise Training Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menopause
Keywords: Inorganic Nitrate
Menopause
High Intensity Exercise
Vascular Health
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 40
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: Subjects will be randomized to one-month of either high or moderate aerobic exercise training and then further randomized to nitrate or placebo.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Menopause greatly increases cardiovascular disease risk (CVD). Current exercise guidelines are inadequate to ameliorate this risk and higher intensity exercise may be necessary for cardiovascular benefits in postmenopausal females. Oral nitrate supplementation enhances exercise performance and CVD risk profile in several clinical conditions. The investigators recently reported that 3-days of nitrate supplementation in postmenopausal females enhances acute post-exercise vascular function, in an intensity dependent manner. The effects of nitrate supplementation and exercise training over a longer training program remains unexplored. This investigation will examine the impact of exercise training intensity with and without inorganic nitrate supplementation, on CVD and fitness outcomes. Postmenopausal females will be tested for maximal oxygen uptake and lactate threshold before randomization to one of four groups: that inorganic nitrate-rich tablets, or tablets with nitrate extracted; and assigned to one-month of calorie matched high-intensity or moderate-intensity exercise training. Vascular function and fitness will be evaluated before and after training.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal female (greater than age 45 but less than age 75)
* Sedentary (does not exercise regularly or less than 2 bouts of exercise per week)
* 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)
* Diabetes
* 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.)
* Oral antibiotic use within previous four weeks
* Oral disease or poor oral health as determined by the Oral Health Questionnaire
* Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use

Primary outcomes:
measure: Vascular Endothelial Function (Flow-Mediated Dilation [FMD])
timeFrame: Baseline and after 1-month of exercise training
measure: Cardiorespiratory Fitness
timeFrame: Baseline and after 1-month of exercise training
Secondary outcomes:
measure: Oral Nitrate Reducing Capacity
timeFrame: Baseline and after 1-month of exercise training
measure: Skeletal muscle perfusion
timeFrame: Baseline and after 1-month of exercise training
measure: Peripheral and Central Blood Pressures
timeFrame: Baseline and after 1-month of exercise training
measure: 24-hour ambulatory blood pressure
timeFrame: Baseline and after 1-month of exercise training
measure: Skeletal muscle microvascular perfusion (near-infra-red- spectroscopy)
timeFrame: Baseline and after 1-month of exercise training
measure: Lipids
timeFrame: Baseline and after 1-month of exercise training
measure: Hemoglobin
timeFrame: Baseline and after 1-month of exercise training
measure: Plasma Nitrate
timeFrame: Baseline and after 1-month of exercise training
measure: Plasma Nitrite
timeFrame: Baseline and after 1-month of exercise training
Other outcomes:
Locations:
Study officials:
affiliation: UVA
name: Jason Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References: