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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
Sponsor:
Information provided by (Responsible Party):
David N. Proctor, PhD, Penn State University

Study Description
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Brief Summary:
The purpose of this study is to test the effects of a one time dose of inorganic nitrate (supplied in the form of beetroot juice) on blood vessel function and resting blood pressure in healthy, postmenopausal women who are within 5 years of menopause. Participants will drink beetroot juice and a placebo juice on separate visits where blood pressure and blood vessel function will be measured.

Condition or disease Intervention/treatment Phase
Postmenopausal Women Drug: nitrate rich beetroot juice Drug: nitrate depleted beetroot juice Phase 2

Detailed Description:
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.

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Nitrate rich beetroot juice
Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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%).

  • Individuals taking any of the following medications:

    1. blood pressure lowering medication (e.g., beta blockers, ACE inhibitors, angiotensin antagonists, calcium channel blockers, diuretics)
    2. lipid- lowering medication (e.g., statins)
    3. nitrates (e.g. nitroglycerin) for angina
    4. phosphodiesterase inhibitors (e.g., Viagra)
    5. anti-Inflammatory drugs
  • Individuals taking hormone therapy
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: David N Proctor, PhD 814-863-0724 dnp3@psu.edu

Locations
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United States, Pennsylvania
Penn State University Recruiting
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Investigators
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Principal Investigator: David N Proctor, PhD Penn State University
More Information
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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

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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
Keywords provided by David N. Proctor, PhD, Penn State University:
dietary nitrate supplementation
beetroot juice