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

NCT05221905 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-30

No results posted yet for this study

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.

Conditions

  • Vascular Dilation
  • Arterial Stiffness

Interventions

DRUG

BEET IT - Concentrate Beet root juice

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.

DRUG

BEET IT - Concentrate Beet root juice (nitrate depleted)

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.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Arthur Weltman, PhD · Professor of Kinesiology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-04-01
Completion
2023-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05221905 on ClinicalTrials.gov