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Dietary Supplement

Nitrite-boosting Therapy for Chronic Kidney Disease

Q: 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.

Q: 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.

Q: How many participants are being selected for this clinical experiment?

Affirmative. The details accessible on clinicaltrials.gov confirms that this <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> 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.

Q: 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).

Q: 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.

Integrative Physiology of Aging Laboratory, Boulder, CO

Nitrate-rich beetroot juice +1 morePhase 4RecruitingLed by Matthew J Rossman, PhDResearch Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Albumin > 3.0 g/dL

Body mass index (BMI) <40 kg/m2 (vascular function measurements can be inaccurate in severely obese patients)

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline, 3 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

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.

Eligible Conditions

Chronic Kidney Disease

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

Your albumin level is higher than 3.0 grams per deciliter.

Select...

Your body mass index (BMI) is less than 40 kg/m2.

Select...

You have moderate to severe kidney disease, based on a specific test, and your kidney function has been stable for the past 3 months.

Select...

You need to score higher than 21 on a test to make sure you don't have major memory or thinking problems.

Select...

Your blood pressure has been consistently higher than 100/60 mmHg for the past 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, BoulderLead Sponsor

115 Previous Clinical Trials

28,470 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-rich beetroot juice, Nitrate-depleted 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

Recent research and studies

Medicine & Science in Sports & ExerciseJournal

Dietary Nitrate and Nitric Oxide Metabolism: Mouth, Circulation, Skeletal Muscle, and Exercise Performance

Jones, Andrew M., Anni Vanhatalo, Douglas R. Seals, Matthew J. Rossman, Barbora Piknova, and Kristin L. Jonvik. 2020. “Dietary Nitrate and Nitric Oxide Metabolism: Mouth, Circulation, Skeletal Muscle, and Exercise Performance”. Medicine & Science in Sports & Exercise. Ovid Technologies (Wolters Kluwer Health). doi:10.1249/mss.0000000000002470.

clinicaltrials.govStudy

Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease

Douglas Seals 2019. "Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03826147.

All > Chronic Kidney Disease