Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

What this trial studies

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.

Conditions in scope

• Menopause

Interventions

• Nitrate-Rich Beetroot Juice (Dietary Supplement) — subjects will consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day
• High Intensity Exercise (Behavioral) — exercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of \~ 15-17
• Moderate Intensity Exercise (Behavioral) — exercise at the RPE at LT associated an \~ RPE of 10-12
• Nitrate-Depleted Placebo Beetroot Juice (Dietary Supplement) — Subjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day

Who can join

Women only · Ages 45 Years to 75 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-07-01
• Primary completion: 2026-12-31
• Last update posted: 2025-07-28
• First posted: 2024-06-28

Sponsor & contact

Lead sponsor: University of Virginia (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Vascular Endothelial Function (Flow-Mediated Dilation [FMD]) (Baseline and after 1-month of exercise training)
  Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The arteries will be imaged using a high-resolution 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 3 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of…
• Cardiorespiratory Fitness (Baseline and after 1-month of exercise training)
  Peak aerobic capacity (VO2peak) will be assessed using a symptom-limited graded exercise test on a treadmill. An IV will be placed and lactate measured during rest and after the completion of every 3-minute stage to determine lactate threshold at VO2peak.

Related ClearedRx care

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