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Inorganic Nitrate
Nitrate Supplementation for Arterial Stiffness (INCA Trial)
Phase < 1
Waitlist Available
Led By Gary Pierce, PhD
Research Sponsored by Gary L. Pierce
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 50-79 years
Women only: Post-menopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-hours
Awards & highlights
INCA Trial Summary
This trial will study the effects of dietary nitrate on artery stiffness and brain blood flow in older adults.
Who is the study for?
This trial is for women aged 50-79 who are post-menopausal, cognitively healthy or with mild cognitive impairment. They must be able to undergo cardiovascular tests after fasting and without morning medications. Exclusions include severe blood pressure conditions, psychiatric diseases other than dementia, beet allergies, recent tobacco use, significant cardiovascular history, certain neurological disorders or systemic illnesses.Check my eligibility
What is being tested?
The study examines the impact of inorganic nitrate supplementation on arterial stiffness and cerebrovascular function in middle-aged and older adults. Participants will drink either nitrate-rich or nitrate-depleted beetroot juice randomly to see if it affects their blood vessels and brain blood flow.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from consuming beetroot juice could include changes in urine color (beeturia), gastrointestinal discomfort or allergic reactions for those sensitive to beets.
INCA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 79 years old.
Select...
I am a woman and have gone through menopause.
INCA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute change in carotid artery stiffness
Acute change in cerebral blood flow
Secondary outcome measures
Internal carotid artery endothelium-dependent dilation
INCA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Beetroot juiceExperimental Treatment1 Intervention
10-grams of nitrate-containing beetroot concentrate diluted in 120-180 milliliters of water.
Group II: Placebo Beetroot juicePlacebo Group1 Intervention
10 grams of nitrate-depleted beetroot concentrate balanced for anti-oxidant content diluted in 120-180 milliliters of water.
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonOTHER
1,182 Previous Clinical Trials
3,167,334 Total Patients Enrolled
10 Trials studying Aging
2,608 Patients Enrolled for Aging
Gary L. PierceLead Sponsor
4 Previous Clinical Trials
128 Total Patients Enrolled
Gary Pierce, PhDPrincipal InvestigatorUniversity of Iowa
2 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Aging
24 Patients Enrolled for Aging
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 50 and 79 years old.I can fast overnight and skip certain morning medications for heart tests.I have used hormone replacement therapy in the last 6 months.My thyroid function is abnormal and not well-controlled with medication.I have diabetes and need insulin to manage it.I have a chronic lung condition like COPD, cystic fibrosis, or emphysema.I have a history of heart or blood vessel diseases.I do not have any heart conditions or abnormalities.I have no history of stroke or illnesses that could affect my brain function, except for mild cognitive impairment or Alzheimer's.I have Wilson's disease or hemochromatosis.I cannot give informed consent because of cognitive issues.I can lie down comfortably for 90 minutes.I do not have any serious illness or neurological condition that could affect my thinking or brain blood flow, except for mild memory issues.I am on medication that could affect brain blood flow or interact with beetroot juice.I am a woman and have gone through menopause.I have had kidney failure, been on dialysis, or had a kidney transplant.I am currently taking clonidine or a short-acting beta blocker.I have no history of liver disease, HIV/AIDS, or cancer (except for non-melanoma skin cancers).I have or had rheumatoid arthritis, lupus, or Wegener's granulomatosis.
Research Study Groups:
This trial has the following groups:- Group 1: Beetroot juice
- Group 2: Placebo Beetroot juice
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Aging Patient Testimony for trial: Trial Name: NCT03617302 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is the ideal candidate for this trial?
"This clinical study seeks 18 participants with hypertension aged between 50 and 79. Eligibility requirements include: Age range of 50-79, cognitively sound or mild impairment, capacity to recline for a maximum of 90 minutes, willing and able undertake cardiovascular tests (including fasting overnight & withholding medication)."
Answered by AI
How extensive is the enrollment for this research endeavor?
"Affirmative. According to information available on clinicaltrials.gov, this medical research is currently recruiting individuals for the study which was initially posted in November 2018 and modified recently in May 2022. 18 participants are needed from a single location."
Answered by AI
Does this research extend to geriatric populations?
"Only individuals aged 50-79 can join this clinical trial; 83 separate studies are accepting participants younger than 18, while 1430 medical trials accept those over 65."
Answered by AI
Is this experiment enrolling participants at present?
"According to the records maintained on clinicaltrials.gov, this trial is presently accepting patients for enrollment. The study was first posted November 1st 2018 and its details have been modified as recently as May 25th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
University of Iowa
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I really want to help find a cure for my children.
PatientReceived no prior treatments
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