Clinical trial NCT03644472: Postmenopausal Women and Their Endothelium
Official title: Postmenopausal Women and Their Endothelium: Is Dietary Nitrate Supplementation Protective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal Women
Keywords: dietary nitrate supplementation
beetroot juice
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 37
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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:

  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

Primary outcomes:
measure: Macro-vascular reactivity
timeFrame: 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
measure: Micro-vascular reactivity
timeFrame: 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
Secondary outcomes:
measure: Resting blood pressures
timeFrame: Change from baseline resting blood pressure and at 90 minutes after beet root juice ingestion
measure: Recovery of micro-vascular function and brachial artery flow mediated dilation
timeFrame: Change in these measures from immediately after ischemia-reperfusion injury to 30 minutes following
measure: Brachial artery flow-mediated dilation
timeFrame: 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
measure: Brachial ankle pulse wave velocity and ankle-brachial index
timeFrame: These measurements will take place before (day 1) and 24 hours after (day 8) 7 days of supplementation.
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: David N Proctor, PhD
role: PRINCIPAL_INVESTIGATOR
References: