Menu
Recruiting NCT06480695

Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

No phase Interventional Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nitrate-Rich Beetroot Juice, High Intensity Exercise, Moderate Intensity Exercise, Nitrate-Depleted Placebo Beetroot Juice.
Who it may be relevant to
Registry conditions: Menopause. Basic parameters: 45 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Dietary supplement Nitrate-Rich Beetroot Juice
    subjects will consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day
  • Behavioral High Intensity Exercise
    exercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of \~ 15-17
  • Behavioral Moderate Intensity Exercise
    exercise at the RPE at LT associated an \~ RPE of 10-12
  • Dietary supplement Nitrate-Depleted Placebo Beetroot Juice
    Subjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day

Primary outcome measures

  • 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]
Secondary outcome measures (9)
  • Oral Nitrate Reducing Capacity [Time frame: Baseline and after 1-month of exercise training]
  • Skeletal muscle perfusion [Time frame: Baseline and after 1-month of exercise training]
  • Peripheral and Central Blood Pressures [Time frame: Baseline and after 1-month of exercise training]
  • 24-hour ambulatory blood pressure [Time frame: Baseline and after 1-month of exercise training]
  • Skeletal muscle microvascular perfusion (near-infra-red- spectroscopy) [Time frame: Baseline and after 1-month of exercise training]
  • Lipids [Time frame: Baseline]
  • Hemoglobin [Time frame: Baseline and after 1-month of exercise training]
  • Plasma Nitrate [Time frame: Baseline and after 1-month of exercise training]
  • Plasma Nitrite [Time frame: Baseline and after 1-month of exercise training]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Student Health and Wellness Building - Department of Kinesiology — Charlottesville

Identifiers

NCT: NCT06480695 · HSR231665

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗