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CompletedNCT05401409BEET-PKDUpdated Jun 8, 2025Results posted

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

An interventional study of Beetroot juice and Nitrate-depleted beetroot juice in Autosomal Dominant Polycystic Kidney, Hypertension and Endothelial Dysfunction, sponsored by Western Sydney Local Health District. Completed at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.

Sponsored by Western Sydney Local Health District · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Autosomal Dominant Polycystic Kidney
  • Hypertension
  • Endothelial Dysfunction

Keywords

  • Autosomal Dominant Polycystic Kidney Disease
  • ADPKD
  • Beetroot juice
  • Hypertension
  • Nitrate supplementation
  • Nitric oxide
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Nitrate-rich beetroot juice

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

    Dietary Supplement: Beetroot juice

  • Placebo comparator
    Nitrate-depleted beetroot juice

    Beetroot juice with nitrate removed

    Dietary Supplement: Nitrate-depleted beetroot juice

Interventions

  • Dietary supplementBeetroot juice

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

    Also known as: Beet It Sport Shot

  • Dietary supplementNitrate-depleted beetroot juice

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

05

What researchers measure

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)

    Time frame: 4 weeks

Secondary outcomes

  1. 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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

  5. 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

    Time frame: 4 weeks

06

Results

Posted Jun 8, 2025

Participant flow

Participant flow — Overall Study
MilestoneNitrate-rich Beetroot JuiceNitrate-depleted Beetroot Juice
Started3030
Completed2930
Not completed10
Withdrew: Lost to follow-up10

Outcome measures

PrimaryChange 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)

Time frame:
4 weeks
Reported as:
Mean · mmHg
Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)
mmHgNitrate-rich Beetroot JuiceNitrate-depleted Beetroot Juice
Systolic blood pressure-5.36 ± 12.69-7.65 ± 14.07
Diastolic blood pressure-3.55 ± 7.08-2.73 ± 7.81
SecondaryAverage 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

Time frame:
4 weeks
Reported as:
Mean · mmHg/week
Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks
mmHg/weekNitrate-rich Beetroot JuiceNitrate-depleted Beetroot Juice
Systolic blood pressure-0.51 (-1.40 to 0.38)-0.55 (-1.42 to 0.31)
Diastolic blood pressure-0.24 (-0.85 to 0.38)-0.47 (-1.07 to 0.13)
SecondaryUrinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)
Time frame:
4 weeks
Reported as:
Median · mg/mmol
Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)
mg/mmolNitrate-rich Beetroot JuiceNitrate-depleted Beetroot Juice
Baseline2.2 (0.4 to 5.4)3.9 (1.7 to 9.0)
4 weeks (end of study)2.5 (0.2 to 5.8)3.6 (0.9 to 13.9)
SecondaryChange in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
Time frame:
4 weeks
Reported as:
Median · µM
Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
µMNitrate-rich Beetroot JuiceNitrate-depleted Beetroot Juice
Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)20.08 (6.60 to 30.68)0.97 (-1.83 to 3.71)
SecondaryChange in Salivary Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
Time frame:
4 weeks

Results for this outcome have not been posted.

SecondarySerum 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

Time frame:
4 weeks
Reported as:
Median · umol/L
Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study)
umol/LNitrate-rich Beetroot JuiceNitrate-depleted Beetroot Juice
Baseline ADMA level0.47 ± 0.080.47 ± 0.09
4 week ADMA level (end of study)0.50 ± 0.100.52 ± 0.11

Adverse events

Collected over 4 weeks (from enrollment to end of follow up). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nitrate-rich Beetroot Juice0/29 (0%)0/29 (0%)18/29 (62.1%)
Nitrate-depleted Beetroot Juice0/30 (0%)0/30 (0%)11/30 (36.7%)
Most frequent other events
Most frequent other events
EventNitrate-rich Beetroot JuiceNitrate-depleted Beetroot Juice
Beet-coloured faecesGastrointestinal disorders18/2911/30
BeeturiaRenal and urinary disorders15/297/30
Gastrointestinal symptoms (not serious adverse event)Gastrointestinal disorders13/2910/30
Change in bowel habitGastrointestinal disorders12/298/30
BloatingGastrointestinal disorders5/292/30
GastritisGastrointestinal disorders1/293/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)Nitrate-rich Beetroot JuiceNitrate-depleted Beetroot JuiceTotal
Mean49.5 ± 13.549.3 ± 12.4649.4 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)Nitrate-rich Beetroot JuiceNitrate-depleted Beetroot JuiceTotal
Female131427
Male171633
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Nitrate-rich Beetroot JuiceNitrate-depleted Beetroot JuiceTotal
Caucasian202242
Asian8715
Other213
Employment status, categorical (Part time, Full time))
Employment status, categorical (Part time, Full time))(Participants)Nitrate-rich Beetroot JuiceNitrate-depleted Beetroot JuiceTotal
Full time222648
Part time7411
Umemployed101
Factor precipitating diagnosis, categorical (family history screening; pain; hypertension;incidental
Factor precipitating diagnosis, categorical (family history screening; pain; hypertension;incidental(Participants)Nitrate-rich Beetroot JuiceNitrate-depleted Beetroot JuiceTotal
Screening (family history)121325
Pain369
Hypertension8210
Incidental257
Other549
Diagnosis confirmatory test (radiographic)
Diagnosis confirmatory test (radiographic)(Participants)Nitrate-rich Beetroot JuiceNitrate-depleted Beetroot JuiceTotal
Count of participants303060
Age at diagnosis
Age at diagnosis(years)Nitrate-rich Beetroot JuiceNitrate-depleted Beetroot JuiceTotal
Mean30.9 ± 13.3133.1 ± 13.132 ± 13.2
Family history of ADPKD
Family history of ADPKD(Participants)Nitrate-rich Beetroot JuiceNitrate-depleted Beetroot JuiceTotal
Yes222345
No8412
Unknown033
07

Study locations

2 sites
  • Westmead Hospital
    Sydney, New South Wales 2145, Australia
  • Westmead Institute for Medical Research
    Westmead, New South Wales 2145, Australia
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 3, 2023

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT05401409
Lead sponsor
Western Sydney Local Health District
Collaborators
Westmead Institute for Medical Research
Responsible party
Gopala K. Rangan (Nephrologist, Western Sydney Local Health District) — Principal investigator
First posted
Jun 2, 2022
Start date
May 5, 2022
Primary completion
Mar 24, 2023
Completion
Mar 24, 2023
Results posted
Jun 8, 2025
Last update
Jun 8, 2025

Study contacts

G K Rangan
principal investigator · Westmead Hospital, Western Sydney Local Health District

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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