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Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

NCT06480695 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Jason Allen, PhD · UVA

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06480695 on ClinicalTrials.gov