Recruiting

Nitrate & Exercise

Sponsor:

University of Virginia

Code:

NCT06480695

Conditions

Menopause

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Nitrate-Rich Beetroot Juice

High Intensity Exercise

Moderate Intensity Exercise

Nitrate-Depleted Placebo Beetroot Juice

Study Details

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 beetroot juice, or beetroot juice 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.

Conditions

Menopause

Study ID

NCT06480695

Start date

Jul 1, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nitrate-Rich Beetroot Juice + High Intensity Exercise (HIE)

Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test.

placebo comparator: Nitrate-Depleted Placebo Beetroot Juice + High Intensity Exercise (HIE)

Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test.

active comparator: Nitrate-Rich Beetroot Juice + Moderate Intensity Exercise (MIE)

Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test.

placebo comparator: Nitrate-Depleted Placebo Beetroot Juice + Moderate Intensity Exercise (MIE)

Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test.

Interventions

Nitrate-Rich Beetroot Juice

subjects will consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day

High Intensity Exercise

exercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of \~ 15-17

Moderate Intensity Exercise

exercise at the RPE at LT associated an \~ RPE of 10-12

Nitrate-Depleted Placebo Beetroot Juice

Subjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day

Primary outcome measure

  • Vascular Endothelial Function (Flow-Mediated Dilation [FMD]) [ Time Frame: Baseline and after 1-month of exercise training ]
  • Cardiorespiratory Fitness [ Time Frame: Baseline and after 1-month of exercise training ]

Central Contacts and Locations

Central contacts

Locations

Student Health and Wellness Building - Department of Kinesiology

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

More Information

Sponsor

University of Virginia

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • Inorganic Nitrate
  • Menopause
  • High Intensity Exercise
  • Vascular Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-07-17.