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Completed

NCT Number: NCT03644472

Postmenopausal Women and Their Endothelium

The purpose of this study is to test the effects of a one time dose and 7-days of inorganic nitrate (supplied in the form of beetroot juice) on blood vessel function and resting blood pressure in healthy, postmenopausal women. Participants will drink beetroot juice and a placebo juice on separate visits where blood pressure and blood vessel function will be measured.

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Key information

Age range

Up to 70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

About this study

Cardiovascular disease is the leading cause of death in the United States. Due to the loss of estrogen, women experience a unique accelerated rise in cardiovascular disease risk factors following menopause. Postmenopausal women represent a population at heightened risk for cardiovascular disease development. Function of the endothelium has been shown to decline across the menopause transition, resulting in less production of nitric oxide. As such the investigators are investigating a potential therapeutic strategy in women have recently undergone menopause to boost nitric oxide availability.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Early post-menopausal women who are within 1-6 years following their final menstrual cycle
  • Late post-menopausal women who are beyond 6 years following their final menstrual cycle

Exclusion criteria

  • Individuals with any overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s).
  • Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)
  • Individuals with a BMI > 35
  • Individuals with resting blood pressure > or = 130/80 mm Hg
  • Individuals with high blood lipids (total cholesterol > or = 240 mg/dl, LDL > or = 160 mg/dl, triglycerides > or = 200 mg/dl).
  • Postmenopausal women with hyperglycemia (fasting glucose > or = 110 mg/dl and HbA1c >6.0%).
  • Individuals taking any of the following medications:
  • blood pressure lowering medication (e.g., beta blockers, ACE inhibitors, angiotensin antagonists, calcium channel blockers, diuretics)
  • lipid- lowering medication (e.g., statins)
  • nitrates (e.g. nitroglycerin) for angina
  • phosphodiesterase inhibitors (e.g., Viagra)
  • anti-Inflammatory drugs
  • Individuals taking hormone therapy

Treatment and study plan

nitrate rich beetroot juice

Drug

This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).

Other names: Beet-It Organic Shot

nitrate depleted beetroot juice

Drug

This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).

Other names: Beet-it Organic Shot Placebo

Primary outcomes

  1. Macro-vascular reactivity

    Time frame: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in macro-vascular reactivity

    Using near-infrared spectroscopy, a probe placed on the forearm muscle will be used to measure the tissue saturation index re-perfusion slope following 5 minutes of forearm cuff occlusion.

  2. Micro-vascular reactivity

    Time frame: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in micro-vascular reactivity

    Using near-infrared spectroscopy, a probe placed on the forearm muscle will be used to measure area under the curve for tissue saturation index re-perfusion following 5 minutes of forearm cuff occlusion.

Secondary outcomes

  1. Resting blood pressures

    Time frame: Change from baseline resting blood pressure and at 90 minutes after beet root juice ingestion

    Resting systolic blood pressures will be measured in the arm (cuff) and estimated in the aorta (radial artery tonometry).

  2. Recovery of micro-vascular function and brachial artery flow mediated dilation

    Time frame: Change in these measures from immediately after ischemia-reperfusion injury to 30 minutes following

    Micro-vascular and brachial artery flow-mediated dilation, as described above, will be reassessed 30 minutes following ischemia-reperfusion injury to determine recovery of vessel function.

  3. Brachial artery flow-mediated dilation

    Time frame: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in brachial artery flow-mediated dilation

    Using doppler ultrasound the brachial artery diameter will be measured before and after 5 minutes of forearm cuff occlusion

  4. Brachial ankle pulse wave velocity and ankle-brachial index

    Time frame: These measurements will take place before (day 1) and 24 hours after (day 8) 7 days of supplementation.

    Using the VP-Colin 2000 brachial ankle pulse wave velocity and ankle brachial index will be measured before and after supplementation

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Postmenopausal Women and Their Endothelium: Is Dietary Nitrate Supplementation Protective

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2018
Registry last updated
Feb 27, 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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