Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06480695
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 75 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Student Health and Wellness Building - Department of KinesiologyCharlottesvilleVirginia22903
Casey Derella, PhD
[email protected]
434-924-1655

Find similar trials in Charlottesville, VA

By condition
Menopause
By specialty
Women's healthFertility
By research site
Student Health and Wellness Building - Department of Kinesiology· Charlottesville, VA

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