Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease

Not Applicable

Completed

• Conditions: Hypertension; Endothelial Dysfunction; Autosomal Dominant Polycystic Kidney

• Registration Number: NCT05401409
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-05
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-02
• Primary Completion: 2023-03-24
• Study Completion: 2023-03-24
• Results First Submitted: 2025-04-03
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Results First Posted: 2025-06-08
• Last Update Posted: 2025-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)	4 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks	4 weeks	Reported change in blood pressure is average change per week, over 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)	4 weeks	Asymmetric dimethylarginine (ADMA) which is a recognized marker of endothelial dysfunction and inhibitor of nitric oxide

Trial Locations

Locations (2)

Westmead Hospital; 🇦🇺 Sydney, New South Wales, Australia

Westmead Institute for Medical Research; 🇦🇺 Westmead, New South Wales, Australia