NCT05401409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 8, 2025

Completed
Last Updated

June 8, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 27, 2022

Results QC Date

April 3, 2025

Last Update Submit

May 26, 2025

Conditions

Autosomal Dominant Polycystic KidneyHypertensionEndothelial Dysfunction

Keywords

Autosomal Dominant Polycystic Kidney DiseaseADPKDBeetroot juiceHypertensionNitrate supplementationNitric oxide

Outcome Measures

Primary Outcomes (1)

  • 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)

    4 weeks

Secondary Outcomes (5)

  • Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks

    4 weeks

  • Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)

    4 weeks

  • Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)

    4 weeks

  • Change in Salivary Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)

    4 weeks

  • Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study)

    4 weeks

Study Arms (2)

Nitrate-rich beetroot juice

EXPERIMENTAL

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

Dietary Supplement: Beetroot juice

Nitrate-depleted beetroot juice

PLACEBO COMPARATOR

Beetroot juice with nitrate removed

Dietary Supplement: Nitrate-depleted beetroot juice

Interventions

Beetroot juiceDIETARY_SUPPLEMENT

70mls beetroot juice (400mg nitrate) given daily for 4 weeks

Also known as: Beet It Sport Shot
Nitrate-rich beetroot juice
Nitrate-depleted beetroot juiceDIETARY_SUPPLEMENT

70mls beetroot juice (nitrate-depleted) given daily for 4 weeks

Nitrate-depleted beetroot juice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Westmead Institute for Medical Research

Westmead, New South Wales, 2145, Australia

Location

Related Publications (2)

  • 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.

    PMID: 39356039DERIVED

  • Sagar 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.

    PMID: 37507763DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal DominantHypertension

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, InbornVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Prof Gopala Rangan
Organization
Westmead Hospital and Westmead Institute for Medical Research
g.rangan@sydney.edu.au
8627 3000

Study Officials

  • G K Rangan

    Westmead Hospital, Western Sydney Local Health District

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrologist

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 2, 2022

Study Start

May 5, 2022

Primary Completion

March 24, 2023

Study Completion

March 24, 2023

Last Updated

June 8, 2025

Results First Posted

June 8, 2025

Record last verified: 2025-05

Locations

AU(2)