Penn State University
University Park, Pennsylvania, 16802, United States
NCT Number: NCT03644472
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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Notify MeUp to 70 year
Female
Interventional
Phase 2
University Park, Pennsylvania, 16802, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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.
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).
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.
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
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
Penn State University
Other
Postmenopausal Women and Their Endothelium: Is Dietary Nitrate Supplementation Protective
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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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