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

Hypertension Clinical Trial

— BEET-PKD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05401409
• Other study ID #: 2020_ETH01718
• Status: Completed
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: March 24, 2023

Study information

• Verified date: April 2023
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthrogryposis
• Autosomal Dominant Polycystic Kidney
• Endothelial Dysfunction
• Hypertension
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Dietary Supplement:
• Beetroot juice
70mls beetroot juice (400mg nitrate) given daily for 4 weeks
• Nitrate-depleted beetroot juice
70mls beetroot juice (nitrate-depleted) given daily for 4 weeks

Locations

Country	Name	City	State
Australia	Westmead Hospital	Sydney	New South Wales
Australia	Westmead Institute for Medical Research	Westmead	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Western Sydney Local Health District	Westmead Institute for Medical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinic systolic and diastolic blood pressure from baseline until end of study		4 weeks
Secondary	Change in daily home systolic and diastolic blood pressure from baseline until the end of the study		4 weeks
Secondary	Change in urinary albumin to creatinine ratio from baseline until the end of the study		4 weeks
Secondary	Change in serum nitrate/nitrite levels from baseline until the end of the study		4 weeks
Secondary	Change in salivary nitrate/nitrite levels from baseline until the end of the study		4 weeks
Secondary	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