Trial Outcomes & Findings for Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease (NCT NCT05401409)
NCT ID: NCT05401409
Last Updated: 2025-06-08
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-06-08
Participant Flow
Participant milestones
| Measure |
Nitrate-rich Beetroot Juice
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
Beetroot juice: 70mls beetroot juice (400mg nitrate) given daily for 4 weeks
|
Nitrate-depleted Beetroot Juice
Beetroot juice with nitrate removed
Nitrate-depleted beetroot juice: 70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Nitrate-rich Beetroot Juice
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
Beetroot juice: 70mls beetroot juice (400mg nitrate) given daily for 4 weeks
|
Nitrate-depleted Beetroot Juice
Beetroot juice with nitrate removed
Nitrate-depleted beetroot juice: 70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease
Baseline characteristics by cohort
| Measure |
Nitrate-rich Beetroot Juice
n=30 Participants
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
Beetroot juice: 70mls beetroot juice (400mg nitrate) given daily for 4 weeks
|
Nitrate-depleted Beetroot Juice
n=30 Participants
Beetroot juice with nitrate removed
Nitrate-depleted beetroot juice: 70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 12.46 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Employment status, categorical (Part time, Full time))
Full time
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Employment status, categorical (Part time, Full time))
Part time
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Employment status, categorical (Part time, Full time))
Umemployed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Factor precipitating diagnosis, categorical (family history screening; pain; hypertension;incidental
Screening (family history)
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Factor precipitating diagnosis, categorical (family history screening; pain; hypertension;incidental
Pain
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Factor precipitating diagnosis, categorical (family history screening; pain; hypertension;incidental
Hypertension
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Factor precipitating diagnosis, categorical (family history screening; pain; hypertension;incidental
Incidental
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Factor precipitating diagnosis, categorical (family history screening; pain; hypertension;incidental
Other
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Diagnosis confirmatory test (radiographic)
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age at diagnosis
|
30.9 years
STANDARD_DEVIATION 13.31 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
32 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Family history of ADPKD
Yes
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Family history of ADPKD
No
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Family history of ADPKD
Unknown
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: One patient in the nitrate-rich group was lost to follow-up.
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)
Outcome measures
| Measure |
Nitrate-rich Beetroot Juice
n=29 Participants
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
|
Nitrate-depleted Beetroot Juice
n=30 Participants
Beetroot juice with nitrate removed
|
|---|---|---|
|
Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)
Systolic blood pressure
|
-5.36 mmHg
Standard Deviation 12.69
|
-7.65 mmHg
Standard Deviation 14.07
|
|
Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)
Diastolic blood pressure
|
-3.55 mmHg
Standard Deviation 7.08
|
-2.73 mmHg
Standard Deviation 7.81
|
SECONDARY outcome
Timeframe: 4 weeksReported change in blood pressure is average change per week, over 4 weeks
Outcome measures
| Measure |
Nitrate-rich Beetroot Juice
n=29 Participants
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
|
Nitrate-depleted Beetroot Juice
n=30 Participants
Beetroot juice with nitrate removed
|
|---|---|---|
|
Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks
Systolic blood pressure
|
-0.51 mmHg/week
Interval -1.4 to 0.38
|
-0.55 mmHg/week
Interval -1.42 to 0.31
|
|
Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks
Diastolic blood pressure
|
-0.24 mmHg/week
Interval -0.85 to 0.38
|
-0.47 mmHg/week
Interval -1.07 to 0.13
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Nitrate-rich Beetroot Juice
n=29 Participants
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
|
Nitrate-depleted Beetroot Juice
n=30 Participants
Beetroot juice with nitrate removed
|
|---|---|---|
|
Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)
Baseline
|
2.2 mg/mmol
Interval 0.4 to 5.4
|
3.9 mg/mmol
Interval 1.7 to 9.0
|
|
Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)
4 weeks (end of study)
|
2.5 mg/mmol
Interval 0.2 to 5.8
|
3.6 mg/mmol
Interval 0.9 to 13.9
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Nitrate-rich Beetroot Juice
n=29 Participants
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
|
Nitrate-depleted Beetroot Juice
n=30 Participants
Beetroot juice with nitrate removed
|
|---|---|---|
|
Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)
|
20.08 µM
Interval 6.6 to 30.68
|
0.97 µM
Interval -1.83 to 3.71
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksAsymmetric dimethylarginine (ADMA) which is a recognized marker of endothelial dysfunction and inhibitor of nitric oxide
Outcome measures
| Measure |
Nitrate-rich Beetroot Juice
n=29 Participants
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
|
Nitrate-depleted Beetroot Juice
n=30 Participants
Beetroot juice with nitrate removed
|
|---|---|---|
|
Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study)
Baseline ADMA level
|
0.47 umol/L
Standard Deviation 0.08
|
0.47 umol/L
Standard Deviation 0.09
|
|
Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study)
4 week ADMA level (end of study)
|
0.50 umol/L
Standard Deviation 0.10
|
0.52 umol/L
Standard Deviation 0.11
|
Adverse Events
Nitrate-rich Beetroot Juice
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Nitrate-depleted Beetroot Juice
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nitrate-rich Beetroot Juice
n=29 participants at risk
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
|
Nitrate-depleted Beetroot Juice
n=30 participants at risk
Beetroot juice with nitrate removed
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal symptoms (not serious adverse event)
|
44.8%
13/29 • 4 weeks (from enrollment to end of follow up)
|
33.3%
10/30 • 4 weeks (from enrollment to end of follow up)
|
|
Gastrointestinal disorders
Change in bowel habit
|
41.4%
12/29 • 4 weeks (from enrollment to end of follow up)
|
26.7%
8/30 • 4 weeks (from enrollment to end of follow up)
|
|
Gastrointestinal disorders
Bloating
|
17.2%
5/29 • 4 weeks (from enrollment to end of follow up)
|
6.7%
2/30 • 4 weeks (from enrollment to end of follow up)
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29 • 4 weeks (from enrollment to end of follow up)
|
10.0%
3/30 • 4 weeks (from enrollment to end of follow up)
|
|
Renal and urinary disorders
Beeturia
|
51.7%
15/29 • 4 weeks (from enrollment to end of follow up)
|
23.3%
7/30 • 4 weeks (from enrollment to end of follow up)
|
|
Gastrointestinal disorders
Beet-coloured faeces
|
62.1%
18/29 • 4 weeks (from enrollment to end of follow up)
|
36.7%
11/30 • 4 weeks (from enrollment to end of follow up)
|
Additional Information
Prof Gopala Rangan
Westmead Hospital and Westmead Institute for Medical Research
Phone: 8627 3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place