NCT05221905

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Vascular Dilation
• Arterial Stiffness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2022-02-03
• Last updated: 2023-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study