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NCT03617302CompletedEarly phase 1

Inorganic Nitrate Supplementation on Cerebrovascular Aging and Arterial Stiffness Study

Effects of Inorganic Nitrate Supplementation on Cerebrovascular Aging and Arterial Stiffness Study

Source: ClinicalTrials.gov · Last updated 4 Mar 2026

Brief summary (registry, in English)

This study investigates the effect of dietary inorganic nitrate supplementation on 1) large elastic artery stiffness and hemodynamics and 2) cerebrovascular function in middle-aged and older adults. Participants will be randomized to consume either nitrate-containing or nitrate-depleted beetroot juice.

Status (registry)
Completed
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
16 (actual)
First submitted
30 Jul 2018
Start date
1 Nov 2018
Primary completion date
30 Dec 2022
Lead sponsor
Gary L. Pierce, PhD
NCT number
NCT03617302

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 16
  • From 1 Nov 2018 to the primary completion date, 30 Dec 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently taking medications that may affect cerebral blood flow (e.g. papaverine, indomethacin, acetazolamide, etc) or efficacy of beetroot juice (proton pump inhibitors)
  • Current clinically abnormal thyroid function not adequately regulated by thyroid hormone supplementation or medication.
  • Unwillingness to wash out from a vitamin or dietary supplement regime prior to enrollment and maintain throughout the duration of the study.
  • Inability to fast or hold morning medications doses until after testing is complete.
  • Currently enrolled in another study using an study medication, supplement, device or intervention.

Other illness

  • Current or history of cardiovascular disease disease (heart attack, stroke, heart failure, cardiomyopathy or peripheral artery disease, heart angioplasty/stent or bypass surgery, valve replacement, carotid endarterectomy, heart transplant.
  • Medical history of stroke or other neurological disorder or systemic illness that could potentially affect cognition or brain function (outside of a diagnosis of Mild Cognitive impairment, Alzheimer's Disease) or could affect their safety or comfort while undergoing the imaging or cardiovascular studies.
  • Subjects with evidence of cardiovascular disease at baseline or during the exercise test (evidence of myocardial infarction, abnormal cardiac arrhythmia, myocardial ischemia, conduction delays, \>1mm S-T segment depression or elevation; \>3 beat ventricular tachycardia; atrial fibrillation) will be excluded from the study.
  • Wilson's disease, hemochromatosis
  • Medical history of chronic major psychiatric or current diagnosis of major psychiatric disease (other than dementia).
  • Systemic illness or neurological disorder potentially affecting cognition or cerebral blood flow other than mild cognitive impairment
  • Unable to provide informed consent due to cognitive impairment
  • Allergic to beets
  • Current tobacco user or history of tobacco use within the past 3 months (cigarettes, cigars, chewing tobacco, hookah, electronic cigarettes) or living with someone who smokes/has smoked in the past 3 months.
  • Current diagnosis of insulin-dependent diabetes (Type I or insulin dependent Type II)
  • Current diagnosis of chronic obstructive lung disease, cystic fibrosis, emphysema, chronic bronchitis
  • History of renal failure, dialysis or kidney transplant
  • Current diagnosis or history of liver disease or HIV/AIDS, or cancer (other than non-melanoma skin cancers).
  • Current diagnosis or history of rheumatoid arthritis, systemic lupus erythematosus, Wegener's granulomatosis
  • Uncontrolled intercurrent illness that would limit compliance with study requirements per investigator.

Other

  • Individuals taking clonidine or other short-acting beta blocker
  • Resting blood pressure \> 200/ 110 mmHg or systolic \<90 mmHg
  • Vulnerable populations (prisoners, etc) will not be eligible.
  • Inability to comply with experimental instructions.
  • Hormone replacement use within the past 6 months

Who the study is looking for

  • Age 50-79 years
  • Cognitively healthy, having mild cognitive impairment
  • Able to undergo cardiovascular testing procedures including fasting overnight and holding selected morning medication doses.
  • Ability to understand and willingness to sign a written informed consent document.
  • Ability to lie comfortably for up to 90 minutes
  • Women only: Post-menopausal

Age in the registry: 50 years to 79 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Iowa
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.