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Trial record 36 of 561 for:    NITRATE ION

Effect of Inorganic Nitrate Supplement on Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03909789
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Tracking Information
First Submitted Date  ICMJE April 8, 2019
First Posted Date  ICMJE April 10, 2019
Last Update Posted Date April 12, 2019
Actual Study Start Date  ICMJE November 17, 2017
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Rate of change in blood pressure [ Time Frame: 12 weeks ]
change in blood pressure (in millimeters of mercury) over twelve weeks under effect of active treatment and placebo
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
Rate of change in BP and endothelial functionsupplementation on blood pressure in hypertensive men and women [ Time Frame: 12 weeks ]
both systolic and diastolic blood pressure by increasing the bioavailability of Nitric Oxide there by improving the endothelial function
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • changes in serum, plasma and salivary Nitrite and Nitrate [ Time Frame: 12 weeks ]
    change in serum nitrate and nitrate levels (in mcg) over 12 weeks comparing active treatment to placebo
  • cardiometabolic relevant biomarkers (as compared to placebo) [ Time Frame: 12 weeks ]
    measures of serum markers of inflammation (Crp) and glucose over 12 weeks in active vs placebo arms
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • changes in serum, plasma and salivary Nitrite and Nitrate, (as compared to placebo) [ Time Frame: 12 weeks ]
    Nitrite (NO2), Nitrate (NO3)- facilitate the bioavailability of nitric oxide (NO)
  • cardiometabolic relevant biomarkers (as compared to placebo) [ Time Frame: 12 weeks ]
    Cardio-metabolic relevant biomarkers including fasting Lipids, Glucose, HbA1c
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Inorganic Nitrate Supplement on Blood Pressure
Official Title  ICMJE Acute and Sustained Effects of Plant- Based Bio-Equivalent Nitrate Supplement Tablets on Blood Pressure Reduction, Nitric Oxide Mediated Endothelial Function and Saliva Bioconversion of Dietary Nitrate in Hypertensive Men and Women
Brief Summary The primary purpose of this project is to assess the efficacy (effectiveness) of plant-based nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on lowering blood pressure (BP), supporting blood vessel function in men and women with hypertension.
Detailed Description This clinical trial is to assess the efficacy of plant-based bioequivalent Nitric Oxide supplement for improving blood pressure and endothelial reactivity over a 12 weeks intervention period in individuals with metabolic syndrome. The study also examines the effect of plant-based bioequivalent Nitric Oxide supplement on other markers of cardiovascular function and cardiovascular disease risk including Total, LDL and HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double Blind Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Blood Pressure
  • Endothelial Dysfunction
Intervention  ICMJE
  • Dietary Supplement: Plant based bioequivalent Nitrate supplementation
    The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.
  • Dietary Supplement: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: plant based bioequivalent dietary nitrate supplement
    The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.
    Intervention: Dietary Supplement: Plant based bioequivalent Nitrate supplementation
  • Placebo Comparator: placebo
    The Placebo does not contain any nitric oxide supplement.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2019)
67
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 22, 2018
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 40-75 years
  • Hypertension >130/85 mmHg; men and women, 1:1 and stable medicated hypertensives
  • Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them

Exclusion Criteria:

  • Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
  • Weight in excess of 250 pounds
  • Bleeding disorder
  • History of known coronary artery disease, myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
  • NYHA Class II- IV heart failure
  • History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
  • Serum creatinine > 1.4 mg/dl
  • Triglycerides > 400 at visit 1
  • Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
  • Concurrent enrollment in another placebo-controlled trial
  • Partial ileal bypass or known gastrointestinal disease limiting drug absorption
  • Current tobacco use
  • Current use of anticoagulants (except for anti-platelet agents)
  • Renal failure
  • History of hypertensive encephalopathy or cerebrovascular accident
  • Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03909789
Other Study ID Numbers  ICMJE 21835-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Sponsor  ICMJE Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP