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

Not Applicable

Completed

• Conditions: Hypertension; Endothelial Dysfunction; Autosomal Dominant Polycystic Kidney
• Interventions: Dietary Supplement: Beetroot juice; Dietary Supplement: Nitrate-depleted beetroot juice

• 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
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

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

Arm && Interventions

Group	Intervention	Description
Nitrate-rich beetroot juice	Beetroot juice	Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
Nitrate-depleted beetroot juice	Nitrate-depleted beetroot juice	Beetroot juice with nitrate removed

Primary Outcome Measures

Name	Time	Method
Change in clinic systolic and diastolic blood pressure from baseline until end of study	4 weeks

Secondary Outcome Measures

Name	Time	Method
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 daily home systolic and diastolic blood pressure 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	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