Postmenopausal Women and Their Endothelium
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ClinicalTrials.gov Identifier: NCT03644472 |
Recruitment Status :
Recruiting
First Posted : August 23, 2018
Last Update Posted : November 26, 2019
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Condition or disease | Intervention/treatment | Phase |
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Postmenopausal Women | Drug: nitrate rich beetroot juice Drug: nitrate depleted beetroot juice | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Postmenopausal Women and Their Endothelium: Is Acute Dietary Nitrate Supplementation Protective |
Actual Study Start Date : | November 7, 2018 |
Estimated Primary Completion Date : | September 3, 2022 |
Estimated Study Completion Date : | September 3, 2024 |
Arm | Intervention/treatment |
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Active Comparator: Nitrate rich beetroot juice
Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
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Drug: nitrate rich beetroot juice
This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
Other Name: Beet-It Organic Shot |
Placebo Comparator: Nitrate depleted beetroot juice
Subjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
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Drug: nitrate depleted beetroot juice
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 Name: Beet-it Organic Shot Placebo |
- 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 the tissue saturation index re-perfusion slope following 5 minutes of forearm cuff occlusion.
- 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.
- 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).
- 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.
- 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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Early post-menopausal women who are within 1-5 years following their final menstrual period
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%).
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644472
Contact: David N Proctor, PhD | 814-863-0724 | dnp3@psu.edu |
United States, Pennsylvania | |
Penn State University | Recruiting |
University Park, Pennsylvania, United States, 16802 |
Principal Investigator: | David N Proctor, PhD | Penn State University |
Responsible Party: | David N. Proctor, PhD, Professor of Kinesiology, Physiology, and Medicine, Penn State University |
ClinicalTrials.gov Identifier: | NCT03644472 History of Changes |
Other Study ID Numbers: |
00010017 |
First Posted: | August 23, 2018 Key Record Dates |
Last Update Posted: | November 26, 2019 |
Last Verified: | November 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
dietary nitrate supplementation beetroot juice |