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Dietary Supplement

Beetroot Juice Therapy for Chronic Kidney Disease

Phase 4
Recruiting
Led By Matthew J Rossman, PhD
Research Sponsored by University of Colorado, Boulder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not taking medications that will interfere with administered medications (e.g., sildenafil interacts with nitroglycerin)
Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 6 min, climb 10 stairs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights

Study Summary

This trial will study whether or not daily oral supplementation of nitrate-rich beetroot juice improves vascular, motor, and cognitive function in patients with chronic kidney disease.

Who is the study for?
This trial is for people with chronic kidney disease stages II-IV who can perform basic motor and cognitive tests, have a stable body weight (BMI <40), normal albumin levels, and blood pressure above 100/60 mmHg. They shouldn't be hospitalized recently, on warfarin, or have severe heart/liver conditions.Check my eligibility
What is being tested?
The study tests if drinking nitrate-rich beetroot juice daily for three months improves blood vessel health, movement ability, and brain function in CKD patients by boosting nitric oxide levels compared to a nitrate-depleted version.See study design
What are the potential side effects?
Potential side effects may include low blood pressure due to the vasodilating effect of nitrates. There's also a small risk of changes in the oxygen-carrying capacity of the blood (methemoglobinemia) especially in those with G6PD deficiency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on medications that would react badly with the trial drugs.
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I can walk, climb stairs, and perform basic tasks without help.
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My kidney function is moderately to severely reduced but stable.
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My blood pressure has been above 100/60 mmHg for the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in aortic stiffness
Change in vascular endothelial function
Secondary outcome measures
Change in endothelial cell markers of oxidative stress
Change in oxidative stress-associated suppression of endothelial function assessed as the increase in brachial artery flow-mediated dilation following an ascorbic acid infusion
Other outcome measures
Fluid cognition composite score
Motor function composite score

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Nitrate-rich beetroot juiceActive Control1 Intervention
Daily dose of nitrate-rich beetroot juice (70 mL) for 3 months.
Group II: Nitrate-depleted beetroot juicePlacebo Group1 Intervention
Daily dose of nitrate-depleted beetroot juice (70 mL) for 3 months. The nitrate-depleted beetroot juice is identical in appearance, taste and caloric content to nitrate-rich beetroot juice, but with nitrate removed.

Find a Location

Who is running the clinical trial?

University of Colorado, BoulderLead Sponsor
119 Previous Clinical Trials
29,167 Total Patients Enrolled
Matthew J Rossman, PhDPrincipal InvestigatorUniversity of Colorado, Boulder
3 Previous Clinical Trials
174 Total Patients Enrolled

Media Library

Nitrate-rich beetroot juice (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03826147 — Phase 4
Chronic Kidney Disease Research Study Groups: Nitrate-depleted beetroot juice, Nitrate-rich beetroot juice
Chronic Kidney Disease Clinical Trial 2023: Nitrate-rich beetroot juice Highlights & Side Effects. Trial Name: NCT03826147 — Phase 4
Nitrate-rich beetroot juice (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03826147 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings in this research project available to participants?

"Affirmative. The information on clinicaltrials.gov reveals that this research endeavor, first established in May of 2019, is actively recruiting participants. 92 individuals are expected to be recruited from one medical site for the trial."

Answered by AI

Has the FDA given authorization to Nitrate-rich beetroot juice?

"There is significant clinical evidence attesting to the safety of nitrate-rich beetroot juice, and thus it earned a rating of 3 on our scale. This treatment has already been approved due to its successful Phase 4 trial."

Answered by AI

How many participants are being selected for this clinical experiment?

"Affirmative. The details accessible on clinicaltrials.gov confirms that this experimental research, which was first posted on May 1st 2019, is currently recruiting participants. A total of 92 individuals must be enrolled at one study site."

Answered by AI

Who meets the entry criteria for this medical study?

"At this moment, 92 individuals suffering from kidney-related maladies between the ages of 30 and 80 are being enrolled in this clinical trial. Eligible applicants must demonstrate a Mini-mental state examination score greater than 21 for cognitive aptitude screening purposes, have a body mass index lower than 40 kg/m2 to ensure accurate vascular functioning measurements, as well as prove their capacity to complete motor and mental tests (e.g., ascend from seated position without difficulty, traverse 6 minutes on foot or climb 10 stairs)."

Answered by AI

Does the trial's protocol include geriatric patients?

"This trial is seeking participants aged between 30 to 80 years old. Separately, 43 studies are dedicated for minors and 457 offer treatment options for individuals over the age of 65."

Answered by AI
~16 spots leftby Mar 2025