Actively Recruiting

Phase Not Applicable
Age: 45Years - 75Years
FEMALE
Healthy Volunteers
NCT06480695

Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

Led by University of Virginia · Updated on 2025-07-28

40

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

Who Can Participate

Age: 45Years - 75Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Post-menopausal female aged greater than 45 but less than 75 years
  • Sedentary lifestyle with less than 2 bouts of exercise per week
  • No major changes in medication in the last 3 months
Not Eligible

You will not qualify if you...

  • Smoking within the last 5 years
  • Weight unstable with loss or gain of more than 3kg in the past 3 months
  • Any medical condition preventing safe exercise
  • Current or recent hormone replacement therapy within last 3 months
  • Diagnosis of diabetes
  • Current or recent use of vasoactive medications such as calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, or proton pump inhibitors
  • Oral antibiotic use within the previous four weeks
  • Oral disease or poor oral health as determined by questionnaire
  • Use of antibacterial or chlorhexidine-containing mouthwash without willingness to discontinue

AI-Screening

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Trial Site Locations

Total: 1 location

1

Student Health and Wellness Building - Department of Kinesiology

Charlottesville, Virginia, United States, 22903

Actively Recruiting

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Research Team

C

Casey Derella, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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