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Completed

NCT Number: NCT05221905

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

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.

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Key information

Conditions

Vascular Dilation Arterial Stiffness

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Student Health and Wellness Center

Charlottesville, Virginia, 22902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BEET IT - Concentrate Beet root juice

Drug

Beet It Sport (James White Drinks, Ltd.) each containing 400mg of inorganic nitrate (~6.5 mmol) will be consumed twice daily (totalling ~13 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits.

Other names: Dietary Nitrate supplementation (nitrate rich)

BEET IT - Concentrate Beet root juice (nitrate depleted)

Drug

Beet It Sport (James White Drinks, Ltd.) each containing 0mg of inorganic nitrate (~0 mmol) will be consumed twice daily (totalling ~0 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. It is provided by the same company that produces the concentrated beet root juice shots (James White Drinks) but the placebo version is nitrate-depleted.

Other names: Dietary Nitrate supplementation (nitrate depleted)

Primary outcomes

  1. Baseline Flow-Mediated Dilation

    Time frame: Baseline (minute 0).

    Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.

  2. Post-Exercise/Control Flow-Mediated Dilation (60 minutes)

    Time frame: 60 minutes post-baseline.

    Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.

  3. Post-Exercise/Control Flow-Mediated Dilation (90 minutes)

    Time frame: 90 minutes post-baseline.

    Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.

  4. Post-Exercise/Control Flow-Mediated Dilation (120 minutes)

    Time frame: 120 minutes post-baseline.

    Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.

  5. Post-Exercise/Control Flow-Mediated Dilation (150 min)

    Time frame: 150 minutes post-baseline.

    Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.

  6. Post-Exercise/Control Flow-Mediated Dilation (180 min)

    Time frame: 180 minutes post-baseline.

    Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.

Secondary outcomes

  1. Baseline Pulse Wave Velocity

    Time frame: Baseline (minute 0).

    Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.

  2. Post-Exercise/Control Pulse Wave Velocity (60 min)

    Time frame: 60 minutes post-baseline.

    Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.

  3. Post-Exercise/Control Pulse Wave Velocity (90 min)

    Time frame: 90 minutes post-baseline.

    Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.

  4. Post-Exercise/Control Pulse Wave Velocity (120 min)

    Time frame: 120 minutes post-baseline.

    Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.

  5. Post-Exercise/Control Pulse Wave Velocity (150 min)

    Time frame: 150 minutes post-baseline.

    Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.

  6. Post-Exercise/Control Pulse Wave Velocity (180 min)

    Time frame: 180 minutes post-baseline.

    Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2022
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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