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

Study Overview
=================
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.

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

Conditions
-----------------
Autosomal Dominant Polycystic Kidney, Hypertension, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: Beetroot juice
* Dietary Supplement: Nitrate-depleted beetroot juice


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinic systolic and diastolic blood pressure from baseline until end of study |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 serum nitrate/nitrite levels from baseline until the end of the study |  | 4 weeks | 
| Change in salivary nitrate/nitrite levels from baseline until the end of the study |  | 4 weeks | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autosomal Dominant Polycystic Kidney Disease, ADPKD, Beetroot juice, Hypertension, Nitrate supplementation, Nitric oxide