search
Back to results

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

Primary Purpose

Autosomal Dominant Polycystic Kidney, Hypertension, Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Beetroot juice
Nitrate-depleted beetroot juice
Sponsored by
Western Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney focused on measuring Autosomal Dominant Polycystic Kidney Disease, ADPKD, Beetroot juice, Hypertension, Nitrate supplementation, Nitric oxide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of ADPKD
  • Age 18 to 70 years
  • Estimated Glomerular Filtration Rate (eGFR) > 30 mL/min/1.73m2
  • Treatment with at least one anti-hypertensive

Exclusion Criteria:

  • Uncontrolled hypertension as diagnosed by the participant's treating nephrologist
  • Unstable blood pressure treatment regimen for ≤28 days
  • Regular use nitrate medications
  • Non-compliant with daily BP readings during screening period
  • Body Mass Index ≥35kg/m2
  • Pregnant or lactating
  • Current cigarette smoking
  • Current active malignancies except for non-melanoma skin cancer
  • Type 1 or Type 2 Diabetes Mellitus diagnosis (elevated fasting glucose and HbA1c > 6.5%)
  • Uncontrolled Hypercholesterolemia (fasting cholesterol > 7.0 mmol/L)
  • Allergy to beetroot
  • Dislike of taste of beetroot juice
  • Unwilling to stop using antiseptic mouthwash
  • Participants enrolled in other clinical trials
  • Participant unable to provide Informed Consent

Sites / Locations

  • Westmead Hospital
  • Westmead Institute for Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nitrate-rich beetroot juice

Nitrate-depleted beetroot juice

Arm Description

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

Beetroot juice with nitrate removed

Outcomes

Primary Outcome Measures

Change in clinic systolic and diastolic blood pressure from baseline until end of study

Secondary Outcome Measures

Change in daily home systolic and diastolic blood pressure from baseline until the end of the study
Change in urinary albumin to creatinine ratio from baseline until the end of the study
Change in serum nitrate/nitrite levels from baseline until the end of the study
Change in salivary nitrate/nitrite levels from baseline until the end of the study
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

Full Information

First Posted
May 27, 2022
Last Updated
April 28, 2023
Sponsor
Western Sydney Local Health District
Collaborators
Westmead Institute for Medical Research
search

1. Study Identification

Unique Protocol Identification Number
NCT05401409
Brief Title
Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
March 24, 2023 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Sydney Local Health District
Collaborators
Westmead Institute for Medical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney, Hypertension, Endothelial Dysfunction
Keywords
Autosomal Dominant Polycystic Kidney Disease, ADPKD, Beetroot juice, Hypertension, Nitrate supplementation, Nitric oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrate-rich beetroot juice
Arm Type
Experimental
Arm Description
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
Arm Title
Nitrate-depleted beetroot juice
Arm Type
Placebo Comparator
Arm Description
Beetroot juice with nitrate removed
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot juice
Other Intervention Name(s)
Beet It Sport Shot
Intervention Description
70mls beetroot juice (400mg nitrate) given daily for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Nitrate-depleted beetroot juice
Intervention Description
70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
Primary Outcome Measure Information:
Title
Change in clinic systolic and diastolic blood pressure from baseline until end of study
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in daily home systolic and diastolic blood pressure from baseline until the end of the study
Time Frame
4 weeks
Title
Change in urinary albumin to creatinine ratio from baseline until the end of the study
Time Frame
4 weeks
Title
Change in serum nitrate/nitrite levels from baseline until the end of the study
Time Frame
4 weeks
Title
Change in salivary nitrate/nitrite levels from baseline until the end of the study
Time Frame
4 weeks
Title
Change in serum asymmetric dimethylarginine from baseline until the end of the study
Description
Asymmetric dimethylarginine (ADMA) which is a recognized marker of endothelial dysfunction and inhibitor of nitric oxide
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G K Rangan
Organizational Affiliation
Westmead Hospital, Western Sydney Local Health District
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Westmead Institute for Medical Research
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs