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

Primary Purpose

Vascular Dilation, Arterial Stiffness

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BEET IT - Concentrate Beet root juice
BEET IT - Concentrate Beet root juice (nitrate depleted)
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vascular Dilation focused on measuring Flow-mediated dilation, Pulse wave velocity, Exercise intensity, Vascular function

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Student Health and Wellness CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Acute High-Intensity Exercise

Acute Moderate-Intensity Exercise

Non-Exercise Control

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Baseline Flow-Mediated Dilation
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.
Post-Exercise/Control Flow-Mediated Dilation (60 minutes)
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.
Post-Exercise/Control Flow-Mediated Dilation (90 minutes)
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.
Post-Exercise/Control Flow-Mediated Dilation (120 minutes)
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.
Post-Exercise/Control Flow-Mediated Dilation (150 min)
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.
Post-Exercise/Control Flow-Mediated Dilation (180 min)
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 Outcome Measures

Baseline Pulse Wave Velocity
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (60 min)
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (90 min)
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (120 min)
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (150 min)
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (180 min)
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.

Full Information

First Posted
October 14, 2021
Last Updated
January 21, 2022
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05221905
Brief Title
Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
Official Title
Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dilation, Arterial Stiffness
Keywords
Flow-mediated dilation, Pulse wave velocity, Exercise intensity, Vascular function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Subject are randomized to consume either beetroot juice with, or without, inorganic nitrate and will consume this same supplement throughout all testing
Masking
ParticipantInvestigator
Masking Description
This is a double-blind study, where neither the investigators nor the subjects will know whether the participants are receiving the active supplement or placebo supplement until study conclusion.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute High-Intensity Exercise
Arm Type
Active Comparator
Arm 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.
Arm Title
Acute Moderate-Intensity Exercise
Arm Type
Active Comparator
Arm 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.
Arm Title
Non-Exercise Control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
BEET IT - Concentrate Beet root juice
Other Intervention Name(s)
Dietary Nitrate supplementation (nitrate rich)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
BEET IT - Concentrate Beet root juice (nitrate depleted)
Other Intervention Name(s)
Dietary Nitrate supplementation (nitrate depleted)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline Flow-Mediated Dilation
Description
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.
Time Frame
Baseline (minute 0).
Title
Post-Exercise/Control Flow-Mediated Dilation (60 minutes)
Description
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.
Time Frame
60 minutes post-baseline.
Title
Post-Exercise/Control Flow-Mediated Dilation (90 minutes)
Description
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.
Time Frame
90 minutes post-baseline.
Title
Post-Exercise/Control Flow-Mediated Dilation (120 minutes)
Description
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.
Time Frame
120 minutes post-baseline.
Title
Post-Exercise/Control Flow-Mediated Dilation (150 min)
Description
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.
Time Frame
150 minutes post-baseline.
Title
Post-Exercise/Control Flow-Mediated Dilation (180 min)
Description
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.
Time Frame
180 minutes post-baseline.
Secondary Outcome Measure Information:
Title
Baseline Pulse Wave Velocity
Description
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Time Frame
Baseline (minute 0).
Title
Post-Exercise/Control Pulse Wave Velocity (60 min)
Description
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Time Frame
60 minutes post-baseline.
Title
Post-Exercise/Control Pulse Wave Velocity (90 min)
Description
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Time Frame
90 minutes post-baseline.
Title
Post-Exercise/Control Pulse Wave Velocity (120 min)
Description
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Time Frame
120 minutes post-baseline.
Title
Post-Exercise/Control Pulse Wave Velocity (150 min)
Description
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Time Frame
150 minutes post-baseline.
Title
Post-Exercise/Control Pulse Wave Velocity (180 min)
Description
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Time Frame
180 minutes post-baseline.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All subjects are post-menopausal females.
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur Weltman, PhD
Phone
(434) 924-6191
Email
alw2v@virginia.edi
First Name & Middle Initial & Last Name or Official Title & Degree
Austin C Hogwood, MS
Phone
(804) 536-7036
Email
ach2jb@virginia.edu
Facility Information:
Facility Name
Student Health and Wellness Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Callen Garrett
Phone
434-243-6155
Email
acm7h@virginia.edu
First Name & Middle Initial & Last Name & Degree
Austin C Hogwood, MS
Phone
8045367036
Email
ach2jb@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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