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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 8, 2018
Sponsor:
Information provided by (Responsible Party):
David N. Proctor, Penn State University

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 23, 2018
Last Update Posted Date November 8, 2018
Actual Study Start Date  ICMJE November 7, 2018
Estimated Primary Completion Date September 3, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • 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 as well as area under the curve following 5 minutes of forearm cuff occlusion.
  • 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
Change History Complete list of historical versions of study NCT03644472 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • Resting blood pressures [ Time Frame: Change from baseline resting systolic blood pressure and at 90 minutes after beet root juice ingestion ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postmenopausal Women and Their Endothelium
Official Title  ICMJE Postmenopausal Women and Their Endothelium: Is Acute Dietary Nitrate Supplementation Protective
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Postmenopausal Women
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Nitrate rich beetroot juice
    Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
    Intervention: Drug: nitrate rich beetroot juice
  • Placebo Comparator: Nitrate depleted beetroot juice
    Subjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
    Intervention: Drug: nitrate depleted beetroot juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 3, 2024
Estimated Primary Completion Date September 3, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: David N Proctor, PhD 814-863-0724 dnp3@psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03644472
Other Study ID Numbers  ICMJE 00010017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David N. Proctor, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David N Proctor, PhD Penn State University
PRS Account Penn State University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP