- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617302
Inorganic Nitrate Supplementation on Cerebrovascular Aging and Arterial Stiffness Study (INCA)
May 22, 2023 updated by: Gary L. Pierce
Effects of Inorganic Nitrate Supplementation on Cerebrovascular Aging and Arterial Stiffness Study
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
Reduced nitric oxide bioavailability with aging contributes in part to increased large central artery stiffness and cerebrovascular dysfunction.
Large central artery stiffness is a risk factor for cognitive decline mediated in part by the development of cerebrovascular dysfunction.
This study will investigate the degree to which improving nitric oxide bioavailability using dietary inorganic nitrate supplementation improves cerebrovascular function through reductions in large central artery stiffness in middle-aged and older adults.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gary L Pierce, PhD
- Phone Number: (319)335-9487
- Email: gary-pierce@uiowa.edu
Study Contact Backup
- Name: Amy Stroud, RN
- Phone Number: 3193562710 (319)356-2710
- Email: amy-stroud@uiowa.edu
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Individuals taking clonidine or other short-acting beta blocker
- Resting blood pressure > 200/ 110 mmHg or systolic <90 mmHg
- 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
- 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.
- 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
- Vulnerable populations (prisoners, etc) will not be eligible.
- Unwillingness to wash out from a vitamin or dietary supplement regime prior to enrollment and maintain throughout the duration of the study.
- Inability to comply with experimental instructions.
- Uncontrolled intercurrent illness that would limit compliance with study requirements per investigator.
- Inability to fast or hold morning medications doses until after testing is complete.
- Hormone replacement use within the past 6 months
- Currently enrolled in another study using an study medication, supplement, device or intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beetroot juice
10-grams of nitrate-containing beetroot concentrate diluted in 120-180 milliliters of water.
|
Experimental
|
Placebo Comparator: Placebo Beetroot juice
10 grams of nitrate-depleted beetroot concentrate balanced for anti-oxidant content diluted in 120-180 milliliters of water.
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute change in carotid artery stiffness
Time Frame: 2-hours
|
Common carotid artery stiffness measured by ultrasonography and applanation tonometry.
|
2-hours
|
Acute change in cerebral blood flow
Time Frame: 2-hours
|
Large cerebral artery blood flow will be measured using 4-Dimensional (4D) phase contrast vastly undersampled isotropic projection imaging (pcVIPR) magnetic resonance imaging (MRI).
|
2-hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Internal carotid artery endothelium-dependent dilation
Time Frame: 2-hours
|
Endothelium-dependent dilation of the internal carotid artery in response to hypercapnia will be measured using ultrasonography.
|
2-hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gary Pierce, PhD, University of Iowa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Actual)
December 30, 2022
Study Completion (Anticipated)
June 30, 2024
Study Registration Dates
First Submitted
July 30, 2018
First Submitted That Met QC Criteria
August 3, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201805720
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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