Hypertension Clinical Trial
— BEET-PKDOfficial 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
Verified date | April 2023 |
Source | Western Sydney Local Health District |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 24, 2023 |
Est. primary completion date | March 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Westmead Hospital | Sydney | New South Wales |
Australia | Westmead Institute for Medical Research | Westmead | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Western Sydney Local Health District | Westmead Institute for Medical Research |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in clinic systolic and diastolic blood pressure from baseline until end of study | 4 weeks | ||
Secondary | Change in daily home systolic and diastolic blood pressure from baseline until the end of the study | 4 weeks | ||
Secondary | Change in urinary albumin to creatinine ratio from baseline until the end of the study | 4 weeks | ||
Secondary | Change in serum nitrate/nitrite levels from baseline until the end of the study | 4 weeks | ||
Secondary | Change in salivary nitrate/nitrite levels from baseline until the end of the study | 4 weeks | ||
Secondary | Change in serum asymmetric dimethylarginine from baseline until the end of the study | Asymmetric dimethylarginine (ADMA) which is a recognized marker of endothelial dysfunction and inhibitor of nitric oxide | 4 weeks |
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