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Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females

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University of Virginia

Status and phase

Completed
Phase 1

Conditions

Vascular Dilation
Arterial Stiffness

Treatments

Drug: BEET IT - Concentrate Beet root juice
Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)

Study type

Interventional

Funder types

Other

Identifiers

NCT05221905
HSR210326

Details and patient eligibility

About

Post-menopausal females experience elevated cardiovascular disease risk (CVD), compared to premenopausal females and age-matched males. Current exercise guidelines appear inadequate to ameliorate this increased risk and higher intensity exercise may be necessary. Oral inorganic nitrate supplementation enhances both exercise performance and CVD risk profile in several clinical conditions. However, the effects of this intervention in post-menopausal females is unexplored.

Full description

The purpose of this study is to determine whether acute inorganic nitrate supplementation and exercising at different exercise intensities (high vs moderate) improve vascular health in post-menopausal females.

Enrollment

24 patients

Sex

Female

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Post-menopausal female, defined as having not had a menstrual cycle for at least 1 year
  • Greater than age 45 but less than age 75
  • Sedentary (does not exercise regularly)
  • 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)
  • 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.)
  • Hysterectomy or oophorectomy

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 3 patient groups, including a placebo group

Acute High-Intensity Exercise
Active Comparator group
Description:
Subjects will exercise at an intensity of 75% of the difference between the lactate threshold and VO2peak until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.
Treatment:
Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)
Drug: BEET IT - Concentrate Beet root juice
Acute Moderate-Intensity Exercise
Active Comparator group
Description:
Subjects will exercise at an intensity at the lactate threshold until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.
Treatment:
Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)
Drug: BEET IT - Concentrate Beet root juice
Non-Exercise Control
Placebo Comparator group
Description:
Measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, without exercise taking place during time points 0-60 min.
Treatment:
Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)
Drug: BEET IT - Concentrate Beet root juice

Trial contacts and locations

1

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Central trial contact

Arthur Weltman, PhD; Austin C Hogwood, MS

Data sourced from clinicaltrials.gov

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