Autosomal Dominant Polycystic KidneyBEET-PKDNCT05401409
Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease
A study testing Beetroot juice and Nitrate-depleted beetroot juice in people with Autosomal Dominant Polycystic Kidney and Hypertension, run by Western Sydney Local Health District at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney, Hypertension, Endothelial Dysfunction
- What is being tested?
- Beetroot juice and Nitrate-depleted beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesAustralia
- Study dates
- 5 May 2022to 24 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Australia2 sites
Westmead Hospital
Sydney, New South Wales, 2145
Westmead Institute for Medical Research
Westmead, New South Wales, 2145
About this study
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
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.
- Being tested
- Beetroot juice, Nitrate-depleted beetroot juice
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, ADPKD, Beetroot juice, Hypertension, Nitrate supplementation, Nitric oxide
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
Also called Beet It Sport Shot
70mls beetroot juice (400mg nitrate) given daily for 4 weeks
Nitrate-depleted beetroot juiceDietary supplement
70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nitrate-rich beetroot juice | Experimental | Beetroot juice containing naturally occurring nitrate (400mg total nitrate) Receives: Dietary Supplement: Beetroot juice |
| Nitrate-depleted beetroot juice | Placebo comparator | Beetroot juice with nitrate removed Receives: Dietary Supplement: Nitrate-depleted beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)
Change in systolic and diastolic blood pressure over two time points - from readings taken at baseline (visit 1) compared with readings taken at 4 weeks (which was the end of the study; visit 3)
Measured: 4 weeks
Secondary outcomes (5)
Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks
Reported change in blood pressure is average change per week, over 4 weeks
Measured: 4 weeks
Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)
Measured: 4 weeks
Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
Measured: 4 weeks
Change in Salivary Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
Measured: 4 weeks
Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study)
Asymmetric dimethylarginine (ADMA) which is a recognized marker of endothelial dysfunction and inhibitor of nitric oxide
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start5 May 2022
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Collaborators
- Westmead Institute for Medical Research
- Responsible party
- Principal investigator, Gopala K. Rangan, Western Sydney Local Health District
- Investigators
- G K Rangan, Principal investigator, Westmead Hospital, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401409
- Sponsor's protocol ID
- 2020_ETH01718
- Acronym
- BEET-PKD
- Status last verified
- May 2025
- First submitted
- 27 May 2022
- Last updated
- 8 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PubMed 39356039Sagar PS, Munt A, Saravanabavan S, Vahedi FA, Elhindi J, Nguyen B, Chau K, Harris DC, Lee V, Sud K, Wong N, Rangan GK. Efficacy of beetroot juice on reducing blood pressure in hypertensive adults with autosomal dominant polycystic kidney disease (BEET-PKD): study protocol for a double-blind, randomised, placebo-controlled trial. Trials. 2023 Jul 29;24(1):482. doi: 10.1186/s13063-023-07519-2.
PubMed 37507763
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05401409
- Acronym / sponsor ID
- BEET-PKD / 2020_ETH01718
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, ADPKD, Beetroot juice, Hypertension, Nitrate supplementation, Nitric oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Collaborators
- Westmead Institute for Medical Research
- Study start
- 5 May 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Posted 8 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate-rich beetroot juice | Experimental | Dietary Supplement: Beetroot juiceBeetroot juice containing naturally occurring nitrate (400mg total nitrate) |
| Nitrate-depleted beetroot juice | Placebo comparator | Dietary Supplement: Nitrate-depleted beetroot juiceBeetroot juice with nitrate removed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juiceAlso: Beet It Sport Shot70mls beetroot juice (400mg nitrate) given daily for 4 weeks | Dietary supplement | Nitrate-rich beetroot juice |
| Nitrate-depleted beetroot juice70mls beetroot juice (nitrate-depleted) given daily for 4 weeks | Dietary supplement | Nitrate-depleted beetroot juice |
Primary outcome
Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)
Time frame: 4 weeks
Change in systolic and diastolic blood pressure over two time points - from readings taken at baseline (visit 1) compared with readings taken at 4 weeks (which was the end of the study; visit 3)
5 secondary outcomes
Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks
Time frame: 4 weeks
Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)
Time frame: 4 weeks
Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
Time frame: 4 weeks
Change in Salivary Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
Time frame: 4 weeks
Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39356039St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
- Derived from this study: PubMed 37507763Sagar PS, Munt A, Saravanabavan S, Vahedi FA, Elhindi J, Nguyen B, Chau K, Harris DC, Lee V, Sud K, Wong N, Rangan GK. Efficacy of beetroot juice on reducing blood pressure in hypertensive adults with autosomal dominant polycystic kidney disease (BEET-PKD): study protocol for a double-blind, randomised, placebo-controlled trial. Trials. 2023 Jul 29;24(1):482. doi: 10.1186/s13063-023-07519-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G K Rangan principal investigator
Westmead Hospital, Western Sydney Local Health District
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice and Nitrate-depleted beetroot juice in people with Autosomal Dominant Polycystic Kidney and Hypertension, run by Western Sydney Local Health District at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05401409, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.