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

Western Sydney Local Health District

Status: Completed

Conditions: Hypertension; Autosomal Dominant Polycystic Kidney; Endothelial Dysfunction

Treatments: Dietary Supplement: Nitrate-depleted beetroot juice; Dietary Supplement: Beetroot juice

Study type: Interventional

Funder types: Other

Identifiers

NCT05401409

2020_ETH01718

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Nitrate-rich beetroot juice

Experimental group

Description:

Beetroot juice containing naturally occurring nitrate (400mg total nitrate)

Treatment:

Dietary Supplement: Beetroot juice

Nitrate-depleted beetroot juice

Placebo Comparator group

Description:

Beetroot juice with nitrate removed

Treatment:

Dietary Supplement: Nitrate-depleted beetroot juice