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

NCT ID: NCT05401409

Last Updated: 2025-06-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-05

Study Completion Date

2023-03-24

Brief Summary

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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.

Detailed Description

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Conditions

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Autosomal Dominant Polycystic Kidney Hypertension Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nitrate-rich beetroot juice

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

Group Type EXPERIMENTAL

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

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

Nitrate-depleted beetroot juice

Beetroot juice with nitrate removed

Group Type PLACEBO_COMPARATOR

Nitrate-depleted beetroot juice

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Beetroot juice

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

Intervention Type DIETARY_SUPPLEMENT

Nitrate-depleted beetroot juice

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Beet It Sport Shot

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Westmead Institute for Medical Research

UNKNOWN

Sponsor Role collaborator

Western Sydney Local Health District

OTHER

Sponsor Role lead

Responsible Party

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Gopala K. Rangan

Nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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G K Rangan

Role: PRINCIPAL_INVESTIGATOR

Westmead Hospital, Western Sydney Local Health District

Locations

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Westmead Hospital

Sydney, New South Wales, Australia

Site Status

Westmead Institute for Medical Research

Westmead, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 39356039 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37507763 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2020_ETH01718

Identifier Type: -

Identifier Source: org_study_id

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