Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease (BEET-PKD)

Double-Blind, Randomised Placebo-Controlled Study to Determine the Effect of Beetroot Juice on Reducing Blood Pressure in Hypertensive Adults With Autosomal Dominant Polycystic Kidney Disease

People with autosomal dominant polycystic kidney disease (ADPKD) develop high blood pressure and kidney disease. Previous studies have shown that a commonly occurring chemical, nitric oxide (NO), is reduced in ADPKD, and may contribute, in part, to high blood pressure in this condition. Nitrate is found in high concentrations naturally in beetroots, and increases NO. The aim of this study is to determine if beetroot juice reduces blood pressure in hypertensive people with ADPKD.

Study Overview

• Status: Completed
• Conditions: Hypertension; Endothelial Dysfunction; Autosomal Dominant Polycystic Kidney
• Intervention / Treatment: Dietary supplement: Beetroot juice; Dietary supplement: Nitrate-depleted beetroot juice

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: G K Rangan; Phone Number: 612 8890 6962; Email: g.rangan@sydney.edu.au
• Study Contact Backup: Name: P S Sagar; Phone Number: 612 8627 3529; Email: priyanka.sagar@sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2145
      • Westmead Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Institute for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Autosomal Dominant Polycystic Kidney Disease
• Age > 18 years old
• Estimated Glomerular Filtration Rate (eGFR) > 30 mL/min/1.73m2
• Treatment with at least one anti-hypertensive

Exclusion Criteria:

• Inability to provide Informed Consent
• Labile, unstable, uncontrolled hypertension and/or changes in BP treatment 28 days prior to the screening visit
• Non-compliance with study procedures and/or daily BP measurements during the screening period
• Medical conditions or treatments that might interfere with the generation of NO metabolites or the primary endpoint (e.g. nitrate drugs; cigarette smoking; unwilling to stop using antiseptic mouthwash; severe, uncontrolled hypercholesterolemia; pregnancy or post-partum and lactating)
• Any serious or other medical conditions that might interfere with follow-up or stability of blood pressure (e.g. current active malignancies; uncontrolled diabetes mellitus with elevated HbA1c > 10%)
• Dislike of taste of beetroot juice
• Allergy to beetroot
• Enrolled in other clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitrate-rich beetroot juice; Beetroot juice containing naturally occurring nitrate (400mg total nitrate)	Dietary supplement: Beetroot juice; 70mls beetroot juice (400mg nitrate) given daily for 4 weeks; Other Names: Beet It Sport Shot
Placebo Comparator: Nitrate-depleted beetroot juice; Beetroot juice with nitrate removed	Dietary supplement: Nitrate-depleted beetroot juice; 70mls beetroot juice (nitrate-depleted) given daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in clinic systolic and diastolic blood pressure from baseline until end of study	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily home systolic and diastolic blood pressure from baseline until the end of the study		4 weeks
Change in urinary albumin to creatinine ratio from baseline until the end of the study		4 weeks
Change in serum nitrate/nitrite levels from baseline until the end of the study		4 weeks
Change in salivary nitrate/nitrite levels from baseline until the end of the study		4 weeks
Change in serum asymmetric dimethylarginine from baseline until the end of the study	Asymmetric dimethylarginine (ADMA) which is a recognized marker of endothelial dysfunction and inhibitor of nitric oxide	4 weeks

Collaborators and Investigators

• Sponsor: Western Sydney Local Health District
• Collaborators: Westmead Institute for Medical Research
• Investigators: Principal Investigator: G K Rangan, Westmead Hospital, Western Sydney Local Health District

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Nitric oxide; ADPKD; Autosomal Dominant Polycystic Kidney Disease; Beetroot juice; Nitrate supplementation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Ciliopathies; Hypertension; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Arthrogryposis
• Other Study ID Numbers: 2020_ETH01718

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No