NCT01236872

Brief Summary

Inorganic nitrate can be converted to nitrite and thence nitric oxide in humans. Nitric oxide is normally produced by the inner lining of blood vessels and helps keep blood vessels open and therefore blood pressure lower. In subjects with high blood pressure, the inner lining of the blood vessels does not function adequately. The investigators wish to investigate whether elevating systemic levels of inorganic nitrate (through provision of dietary nitrate-rich vegetables) can elevate levels of nitrate/nitrite in hypertensive subjects, and whether this has a beneficial effect on blood pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Dec 2009

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 8, 2011

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

November 8, 2010

Last Update Submit

August 4, 2011

Conditions

Hypertension

Keywords

NitrateNitriteVegetableAortic stiffness

Outcome Measures

Primary Outcomes (1)

  • Changes in circulating nitrate/nitrite/cGMP levels

    24 hours

Secondary Outcomes (2)

  • Changes in blood pressure

    24 hours

  • arterial stiffness

    3hours

Study Arms (2)

Beetroot juice

EXPERIMENTAL

250ml beetroot juice ingestion

Dietary Supplement: Beetroot juice

Water

PLACEBO COMPARATOR

250ml low-nitrate water placebo

Dietary Supplement: Water

Interventions

Beetroot juiceDIETARY_SUPPLEMENT

250ml once of beetroot juice

Beetroot juice
WaterDIETARY_SUPPLEMENT

250ml once of low-nitrate mineral water

Water

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Grade 1 hypertensive SBP 140-159 or DBP 90-99 on no anti-hypertensives, no target organ damage (TOD), low cardiovascular disease (CVD) risk

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 halfpint (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, ie, codeine for pain management) or alcohol at screening or prior to study medication administration.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary University London

London, EC1M 6BQ, United Kingdom

Location

Related Publications (2)

  • Kapil V, Milsom AB, Okorie M, Maleki-Toyserkani S, Akram F, Rehman F, Arghandawi S, Pearl V, Benjamin N, Loukogeorgakis S, Macallister R, Hobbs AJ, Webb AJ, Ahluwalia A. Inorganic nitrate supplementation lowers blood pressure in humans: role for nitrite-derived NO. Hypertension. 2010 Aug;56(2):274-81. doi: 10.1161/HYPERTENSIONAHA.110.153536. Epub 2010 Jun 28.

    PMID: 20585108BACKGROUND

  • Webb AJ, Patel N, Loukogeorgakis S, Okorie M, Aboud Z, Misra S, Rashid R, Miall P, Deanfield J, Benjamin N, MacAllister R, Hobbs AJ, Ahluwalia A. Acute blood pressure lowering, vasoprotective, and antiplatelet properties of dietary nitrate via bioconversion to nitrite. Hypertension. 2008 Mar;51(3):784-90. doi: 10.1161/HYPERTENSIONAHA.107.103523. Epub 2008 Feb 4.

    PMID: 18250365BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Water

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Amrita Ahluwalia

    QMUL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 9, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 8, 2011

Record last verified: 2011-07

Locations

GB(1)