The Chronic Effects of Beetroot Juice in Hypertensive Subjects
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01405898 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- beetroot juice (Dietary_supplement); Nitrate-free beetroot juice (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Queen Mary University of London
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Change in Clinic Systolic Blood Pressure From Baseline |
-8.7; -1.0 | — |
| PRIMARY Difference in Change in Clinic Diastolic Blood Pressure From Baseline |
-3.2; -0.7 | — |
| PRIMARY Difference in Change in Ambulatory Systolic Blood Pressure From Baseline |
-6.6; 0.8 | — |
| PRIMARY Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline |
-4.3; 0.9 | — |
| SECONDARY Difference in Change in Plasma Nitrite Concentration From Baseline |
0.53; 0.01 | — |
| SECONDARY Difference in Change in Endothelial Function From Baseline |
0.9; 0.1 | — |
| SECONDARY Difference in Change in Arterial Stiffness From Baseline |
-0.59; 0.01 | — |
Summary
Eligibility Criteria
Inclusion Criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Healthy adult male and females between 18 and 85 years of age, inclusive.
- To be eligible, female subjects will be required to state that they are not pregnant, and will not become pregnant during the course of the study.
- Body mass index (BMI) between 18 and 40 kg/m2
- A signed and dated written informed consent prior to admission to the study
- The subject is able to understand and comply with protocol requirements, instructions and protocol---stated restrictions.
and either of the following categories of blood pressure
Category 1---Pre---hypertensive SBP 130---139 or DBP 85---89 on no antihypertensives and will not commence antihypertensives during the course of the study.
Category 2---Grade 1 hypertensive SBP 140---159 or DBP 90---99 on no anti---hypertensives, no target organ damage (TOD), low cardiovascular disease (CVD) risk Category 3---Uncontrolled severe resistant (Grade 3) hypertensive with evidence of difficulty treating to target BP (140/85 or 130/80), with satisfactory adherence to at least one antihypertensive, but insufficient efficacy or intolerance of medications. (Category 3 patients may also be on aspirin and/or a stable dose of cholesterol---lowering medications e.g statins).
Exclusion Criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- History of symptomatic coronary artery disease, stroke, or other known atherosclerotic disease.
- History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders.
- History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, 3x above the upper limit of normal or bilirubin 1.5x above the upper limit of normal at screening.
- Renal impairment with creatinine clearance (eGFR) of 10% at Screen.
- Subjects with LDLc, >7.5 mmol/l. Fasting TG level >6mmol/l.
- History of heart failure defined as NYHA class II --- IV or those with known severe LV dysfunction (EF 28 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of > 21 units (or an average daily intake of greater than 2 units) for females. 1 unit is equivalent to a half---pint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine; or a positive alcohol breath test at the screening visit
- A positive urine test for drugs of abuse (not related to known medications the subject is taking, i.e., codeine for pain management) or alcohol at screening or prior to study medication administration.
- Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication noncompliance, or subject's unwillingness to comply with all study---related study procedures).
- Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
- Subjects with any acute infection, or significant trauma (burns, fractures).
- Subjects who have donated more than 500 mL of blood within 56 days prior to the study.
Data sourced from ClinicalTrials.gov (NCT01405898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.