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 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	Measure Description	Time Frame
Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)	Change in systolic and diastolic blood pressure over two time points - from readings taken at baseline (visit 1) compared with readings taken at 4 weeks (which was the end of the study; visit 3)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks	Reported change in blood pressure is average change per week, over 4 weeks	4 weeks
Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)		4 weeks
Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)		4 weeks
Change in Salivary Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)		4 weeks
Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (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): June 8, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

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: Ciliopathies; Urogenital Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Joint Diseases; Genetic Diseases, Inborn; Musculoskeletal Abnormalities; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; 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