Beetroot Juice Therapy for Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether nitrate-rich beetroot juice can aid people with chronic kidney disease (CKD) by enhancing blood flow, movement, and cognitive skills. Researchers aim to determine if this juice, which increases nitric oxide levels in the body, can prevent further health issues related to CKD. Participants will consume either the nitrate-rich beetroot juice or a similar juice without nitrates for three months. The trial seeks individuals with CKD who can perform basic physical tasks like walking and climbing stairs and who do not have conditions such as alcohol dependence or severe heart problems. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients with CKD.
Will I have to stop taking my current medications?
The trial requires that you do not take medications that interfere with the study's treatment, such as sildenafil, which interacts with nitroglycerin. If you're on such medications, you may need to stop them to participate.
What is the safety track record for these treatments?
A previous study found beetroot juice high in nitrates to be safe and easy for participants to handle. Participants demonstrated a 26% improvement in blood vessel health, indicating a positive effect without serious side effects. This suggests the treatment is generally safe, even for those with chronic kidney disease (CKD).
Another study showed that beetroot juice can help lower blood pressure in CKD patients, which is beneficial. Although beetroot juice contains oxalate, which might raise concerns for kidney health, a reasonable amount is not harmful.
Overall, research has shown that nitrate-rich beetroot juice is safe for use, particularly for those with CKD. Various studies have tested it without major safety issues, supporting its safe use in humans.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard of care for chronic kidney disease, which typically involves medications like ACE inhibitors or ARBs to manage blood pressure and slow disease progression, beetroot juice therapy offers a natural alternative. This treatment is unique because it uses nitrate-rich beetroot juice, which has the potential to improve kidney function through its ability to increase nitric oxide levels, enhancing blood flow and reducing blood pressure. Researchers are excited about this therapy because it provides a non-pharmaceutical option that could complement or even reduce the need for conventional medications, offering patients a more holistic approach to managing their condition.
What evidence suggests that this trial's treatments could be effective for chronic kidney disease?
This trial will compare the effects of nitrate-rich beetroot juice with nitrate-depleted beetroot juice in people with chronic kidney disease (CKD). Research has shown that beetroot juice, rich in nitrates, can benefit those with CKD. Studies have found that it can lower blood pressure, which is crucial since high blood pressure is common in CKD. Additionally, the nitrates in beetroot juice can ease exercise by reducing the oxygen required during physical activity. Furthermore, research suggests that beetroot juice might enhance kidney function by lowering the renal resistive index. Overall, these findings indicate that beetroot juice may improve several health aspects for people with CKD.16789
Who Is on the Research Team?
Matthew J Rossman, PhD
Principal Investigator
University of Colorado, Boulder
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily oral supplementation with nitrate-rich or nitrate-depleted beetroot juice for 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nitrate-depleted beetroot juice
- Nitrate-rich beetroot juice
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Daily dose of nitrate-rich beetroot juice (70 mL) for 3 months.
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 Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Boulder
Lead Sponsor
Citations
The Nitrate-Independent Blood Pressure–Lowering Effect ...
Our results demonstrate the blood pressure–lowering effects of beetroot juice and highlight its potential NO 3 -independent effects.
Plasma Nitrate and Nitrite Kinetics after Single Intake of ... - PMC
Plasma nitrate and nitrite kinetics after single intake of beetroot juice in adult patients on chronic hemodialysis and in healthy volunteers.
THE EFFECT OF DIETARY NITRATE ON EXERCISE ... - PMC
Dietary nitrate supplementation has been shown to have favorable effects on exercise capacity in disease populations by reducing the oxygen cost of exercise.
Beetroot Extract Supplementation Associated With an ...
Patients will ingest 200ml of beet juice (Beta vulgaris) containing approximately 300mg of nitrate (NO3-), and after 2 hours they will be instructed to perform ...
Plasma Nitrate and Nitrite Kinetics after Single Intake of ...
Two groups, one with patients with chronic kidney disease undergoing hemodialysis and a group of healthy participants were randomized to take a beet-root ...
6.
clinicalstudies.pkdcure.org
clinicalstudies.pkdcure.org/study/nitrite-boosting-therapy-for-improving-physiological-function-in-patients-with-chronic-kidney-disease/Nitrite-boosting Therapy for Improving Physiological ...
This study will determine if daily oral treatment (3 months) with a supplement that increases NO in the body (made up of nitrate-rich beetroot juice) improves ...
The Nitrate-Independent Blood Pressure–Lowering Effect of ...
A positive correlation was observed between beetroot juice doses and the mean differences of blood pressures. In contrast, a smaller effect size ...
8.
journals.lww.com
journals.lww.com/jasn/fulltext/2024/10001/inorganic_nitrate_for_improving_vascular.2677.aspxInorganic Nitrate for Improving Vascular Endothelial...
Nitrate-rich BRJ supplementation was safe, well-tolerated and increased FMD BA by 26% (pre: 4.7±0.7%, post: 5.9±0.8%; p=0.03). FMD BA did not change with ...
The Effect of Dietary Nitrates on Physical Performance and ...
In a controlled, double blinded trial, stage 3-5 CKD patients will be randomly assigned to receive either beetroot beverage or a placebo and then complete ...
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