RECRUITING

Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06480695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Post-menopausal female (greater than age 45 but less than age 75)
  2. * Sedentary (does not exercise regularly or less than 2 bouts of exercise per week)
  3. * No major changes in medication in the last 3 months
  1. * Smokers within last 5 years
  2. * Weight unstable (loss/gain of more than 3kg in the past 3 months)
  3. * Any medical condition that prevents the subject from exercising safely
  4. * Hormone replacement therapy (current or within last 3 months)
  5. * Diabetes
  6. * 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.)
  7. * Oral antibiotic use within previous four weeks
  8. * Oral disease or poor oral health as determined by the Oral Health Questionnaire
  9. * Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use

Contacts and Locations

Study Contact

Casey Derella, PhD
CONTACT
434-924-1655
bxg7vn@uvahealth.org

Principal Investigator

Jason Allen, PhD
PRINCIPAL_INVESTIGATOR
UVA

Study Locations (Sites)

Student Health and Wellness Building - Department of Kinesiology
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Jason Allen, PhD, PRINCIPAL_INVESTIGATOR, UVA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Menopause