BEET-PKD: Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease

Sponsor

Western Sydney Local Health District (Other)

Overall Status

Recruiting

CT.gov ID

NCT05401409

Collaborator

Westmead Institute for Medical Research (Other)

Enrollment

Locations

Arms

5.9

Anticipated Duration (Months)

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autosomal Dominant Polycystic Kidney Hypertension Endothelial Dysfunction	Dietary Supplement: Beetroot juice Dietary Supplement: Nitrate-depleted beetroot juice	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 5, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nitrate-rich beetroot juice Beetroot juice containing naturally occurring nitrate (400mg total nitrate)	Dietary Supplement: Beetroot juice 70mls beetroot juice (400mg nitrate) given daily for 4 weeks Other Names: Beet It Sport Shot
Placebo Comparator: Nitrate-depleted beetroot juice Beetroot juice with nitrate removed	Dietary Supplement: Nitrate-depleted beetroot juice 70mls beetroot juice (nitrate-depleted) given daily for 4 weeks

Arm

Intervention/Treatment

Experimental: Nitrate-rich beetroot juice

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

Dietary Supplement: Beetroot juice

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

Other Names:

Beet It Sport Shot

Placebo Comparator: Nitrate-depleted beetroot juice

Beetroot juice with nitrate removed

Dietary Supplement: Nitrate-depleted beetroot juice

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

Outcome Measures

Primary Outcome Measures

Change in clinic systolic and diastolic blood pressure from baseline until end of study [4 weeks]

Secondary Outcome Measures

Change in daily home systolic and diastolic blood pressure from baseline until the end of the study [4 weeks]
Change in urinary albumin to creatinine ratio from baseline until the end of the study [4 weeks]
Change in plasma nitrate/nitrite levels from baseline until the end of the study [4 weeks]
Change in plasma asymmetric dimethylarginine from baseline until the end of the study [4 weeks]
Asymmetric dimethylarginine (ADMA) which is a recognized marker of endothelial dysfunction and inhibitor of nitric oxide

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of ADPKD
Age 18 to 70 years
Estimated Glomerular Filtration Rate (eGFR) > 30 mL/min/1.73m2
Treatment with at least one anti-hypertensive

Exclusion Criteria:

Uncontrolled hypertension as diagnosed by the participant's treating nephrologist
Unstable blood pressure treatment regimen for ≤28 days
Regular use nitrate medications
Non-compliant with daily BP readings during screening period
Body Mass Index ≥35kg/m2
Pregnant or lactating
Current cigarette smoking
Current active malignancies except for non-melanoma skin cancer
Type 1 or Type 2 Diabetes Mellitus diagnosis (elevated fasting glucose and HbA1c > 6.5%)
Uncontrolled Hypercholesterolemia (fasting cholesterol > 7.0 mmol/L)
Allergy to beetroot
Dislike of taste of beetroot juice
Unwilling to stop using antiseptic mouthwash
Participants enrolled in other clinical trials
Participant unable to provide Informed Consent