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RecruitingNCT06480695

Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

Effects of Exercise Training Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
University of Virginia · Academic / Other
Sex
Female
Age
45 Years – 75 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTNitrate-Rich Beetroot Juicesubjects will consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day
BEHAVIORALHigh Intensity Exerciseexercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of \~ 15-17
BEHAVIORALModerate Intensity Exerciseexercise at the RPE at LT associated an \~ RPE of 10-12
DIETARY_SUPPLEMENTNitrate-Depleted Placebo Beetroot JuiceSubjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day

Timeline

Start date
2025-07-01
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2024-06-28
Last updated
2025-07-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06480695. Inclusion in this directory is not an endorsement.