The Chronic Effects of Beetroot Juice in Hypertensive Subjects

NCT01405898 | Completed Results

• 1 other identifier: 08/H0703/91 Chronic
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

We are interested in the effect of diet on blood pressure. Our previous research has shown that beetroot juice lowers blood pressure in healthy people. We now want to see if beetroot juice has this effect in people with high blood pressure. Beetroot juice is naturally rich in nitrate (also found in most other vegetables but particularly in green leafy vegetables). We think that it is the nitrate that lowers the blood pressure.

Conditions

Hypertension

Keywords

hypertension; nitrite; blood pressure; endothelial function

Outcome Measures

Primary Outcomes (4)

• Difference in Change in Clinic Systolic Blood Pressure From Baseline

  4 weeks

• Difference in Change in Clinic Diastolic Blood Pressure From Baseline

  4 weeks

• Difference in Change in Ambulatory Systolic Blood Pressure From Baseline

  4 weeks

• Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline

  4 weeks

Secondary Outcomes (3)

• Difference in Change in Plasma Nitrite Concentration From Baseline

  4 weeks

• Difference in Change in Endothelial Function From Baseline

  4 weeks

• Difference in Change in Arterial Stiffness From Baseline

  4 weeks

Study Arms (2)

Beetroot Juice

EXPERIMENTAL

Dietary Supplement: beetroot juice

Nitrate-free beetroot juice

PLACEBO COMPARATOR

Dietary Supplement: Nitrate-free beetroot juice

Interventions

beetroot juice DIETARY_SUPPLEMENT

Beetroot juice 4 weeks 250ml daily

Beetroot Juice

Nitrate-free beetroot juice DIETARY_SUPPLEMENT

Nitrate-free beetroot juice 4 weeks 250ml daily

Nitrate-free beetroot juice

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 \<50 ml/min at screening.
• Current poorly controlled diabetes mellitus, defined as HbA1c \>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\<30%) regardless of symptomatic status
• History of malignancy within the past 5 years, other than non---melanoma skin cancer.
• Current life---threatening condition other than vascular disease (e.g., very severe chronic airways disease, HIV positive, life---threatening arrhythmias) that may prevent a subject from completing the study.
• Alcohol or drug abuse within the past 6 months.
• Use of an investigational device or investigational drug within 30 days or 5 half---lives (whichever is the longer) preceding the first dose of study medication.
• Subjects who will commence or who are likely to commence treatment with non---steroidal anti--- inflammatory drugs (NSAIDs) (other than aspirin), from screening until study completion.
• Any non---stable dosing of ongoing medication regimens throughout the study trial.
• The subject has a three---month prior history of regular alcohol consumption exceeding an average weekly intake of \> 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University London

London, London, EC1M 6BQ, United Kingdom

Location

Related Publications (1)

• Kapil V, Khambata RS, Robertson A, Caulfield MJ, Ahluwalia A. Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. Hypertension. 2015 Feb;65(2):320-7. doi: 10.1161/HYPERTENSIONAHA.114.04675. Epub 2014 Nov 24.

  PMID: 25421976 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Professor Amrita Ahluwalia
• Organization: Queen Mary University London

a.ahluwalia@qmul.ac.uk

02078825720

Study Officials

• Amrita Ahluwalia

  Queen Mary University London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Vascular Pharmacology

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: January 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2014
• Last Updated: January 8, 2016
• Results First Posted: December 9, 2015

Record last verified: 2015-12

Locations

GB (1)