Clinical trial NCT05401409: Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autosomal Dominant Polycystic Kidney
Hypertension
Endothelial Dysfunction
Keywords: Autosomal Dominant Polycystic Kidney Disease
ADPKD
Beetroot juice
Hypertension
Nitrate supplementation
Nitric oxide
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
Collaborators: name: Westmead Institute for Medical Research
First posted: 2022-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)
timeFrame: 4 weeks
Secondary outcomes:
measure: Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks
timeFrame: 4 weeks
measure: Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)
timeFrame: 4 weeks
measure: Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
timeFrame: 4 weeks
measure: Change in Salivary Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
timeFrame: 4 weeks
measure: Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Institute for Medical Research
state: New South Wales
Study officials:
affiliation: Westmead Hospital, Western Sydney Local Health District
name: G K Rangan
role: PRINCIPAL_INVESTIGATOR
References: