Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors

March 26, 2018 updated by: Vladimir Vuksan, Unity Health Toronto

The Role of Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors: a Randomized, Controlled Trial in Individuals With Elevated Blood Pressure

The project aims to determine the effect of a high-nitrate dietary intervention on blood pressure and markers of vascular function compared to a low-nitrate intervention in people with elevated blood pressure. Half of the participants will receive the high-nitrate dehydrated vegetable intervention, while the other half will receive the low-nitrate dehydrated vegetable intervention.This project will advance the current hypothesis on the therapeutic link between dietary nitrate and high blood pressure, and potentially derive impactful recommendations for individuals at risk of hypertension.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diets rich in fruits and in particular, vegetables, reduce blood pressure (BP) and the risk of cardiovascular events. Increasingly, attention is being given to high-nitrate containing vegetables, with emerging evidence that it might represent a source of vasoactive nitric oxide. Clinical data to date uniformly suggest an acute vasoprotective role of dietary nitrate administration and a BP-lowering effect. Whether the vascular effects extend to long-term intake and in individuals with elevated blood pressure is not well known. The investigators hypothesize that consumption of a dietary intervention high in nitrate from vegetable sources will have a greater effect on BP and related vascular parameters than a similar intervention that is low in dietary nitrates.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Dandan Li, MSc (c)
  • Phone Number: 5527 416 864 6060
  • Email: LiDand@smh.ca

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 18.5-35 kg/m2
  • Seated systolic blood pressure ≥130 and <160 mmHg

Exclusion Criteria:

  • current use of antihypertensive agents
  • history of major cardiovascular events in the last 1 year (stroke or myocardial infarction)
  • stage II hypertension as per JNC7 criteria (systolic BP/ diastolic BP ≥160/100 mmHg) - angina pectoris
  • gastrointestinal (i.e. inflammatory bowel disease, celiac), liver or kidney disease
  • cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure)
  • serum triglyceride >4.5mmol/L
  • major disability or disorder requiring continuous medical attention
  • planned initiation in antihypertensive therapy
  • herb or supplement use that may affect primary outcome
  • consuming >3 servings of vegetables/day (based on semi-quantitative food frequency questionnaire)
  • alcohol use >2 drinks/day
  • chronic or prescribed use of medications including prescription NSAIDs, antacids, warfarin, medications affecting NO synthesis (ie. sildenafil, organic nitrates, etc)
  • use of antibiotics within 3-months of the study start
  • participants should also be willing to refrain from using mouthwash (ie chlorhexidine) for the duration of their participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: High Nitrate Dehydrated Vegetables
Participants are given high-nitrate dehydrated vegetable powders contained in opaque sachets. Participants are advised to consume three sachets per day, over the course of three meals, for 16 weeks.
Other: High-nitrate dehydrated vegetable powder
A mixed combination of vegetable powders that are naturally high in nitrate content, such as beet, spinach, and kale
ACTIVE_COMPARATOR: Low-Nitrate Dehydrated Vegetables
Participants are given low-nitrate dehydrated vegetable powders contained in three opaque sachets. Participants are advised to consume three sachets per day, over the course of three meals, for 16 weeks.
Other: Low-nitrate dehydrated vegetable powder
A mixed combination of vegetable powders that are naturally low in nitrate content, such as peas, tomato, broccoli, carrots, and brussel sprouts

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: Baseline, 8 and16 weeks
Change in systolic blood pressure vs. control at 16 weeks
Baseline, 8 and16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean 24h and Daytime Ambulatory Systolic, Diastolic and Mean Arterial Blood Pressure
Time Frame: Baseline and 16 weeks
Change in mean 24h and daytime ambulatory systolic, diastolic and mean arterial blood pressure vs. control at 16 weeks
Baseline and 16 weeks
Aortic Systolic and Diastolic Blood Pressure
Time Frame: Baseline, 8 and 16 weeks
Change in aortic systolic and diastolic blood pressure vs. control at 16 weeks
Baseline, 8 and 16 weeks
Pulse Wave Velocity (PWV)
Time Frame: Baseline and 16 weeks
Change in PWV vs. control at 16 weeks
Baseline and 16 weeks
Augmentation Index (AI)
Time Frame: Baseline, 8 and 16 weeks
Change in AI vs. control at 16 weeks
Baseline, 8 and 16 weeks
High Sensitivity C-reactive protein (hs-CRP)
Time Frame: Baseline and 16 weeks
Change in hs-CRP vs. control at 16 weeks
Baseline and 16 weeks
Plasma Lipids
Time Frame: Baseline and 16 weeks
Change in Total-C, LDL-C, HDL-C vs. control at 16 weeks
Baseline and 16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptoms Diary
Time Frame: Screening, baseline, 8 and 16 weeks
Record of any adverse symptoms experienced and the level of severity
Screening, baseline, 8 and 16 weeks
Aspartate Aminotransferase (AST)
Time Frame: Screening, baseline, 8 and 16 weeks
Liver function test
Screening, baseline, 8 and 16 weeks
Creatinine
Time Frame: Screening, baseline, 8 and 16 weeks
Kidney function test
Screening, baseline, 8 and 16 weeks
Sachet Count
Time Frame: 8 and 16 weeks
Record of the amount of sachets and contents returned
8 and 16 weeks
7-Day Food Record
Time Frame: Baseline, 8 and 16 weeks
Record of food intake 7 days prior to study visit day
Baseline, 8 and 16 weeks
Nitrate Food Frequency Questionnaire
Time Frame: Biweekly (screening, 0,2,4,6,8,10,12,14,16,18 weeks)
Assess consumption of nitrate-rich meats and vegetables
Biweekly (screening, 0,2,4,6,8,10,12,14,16,18 weeks)
Habitual Physical Activity Questionnaire
Time Frame: Baseline, Week 16
Questions to assess level of physical activity
Baseline, Week 16
Body Weight
Time Frame: Screening, baseline, 8 and 16 weeks
Body Weight in kg
Screening, baseline, 8 and 16 weeks
24h Urinary Nitrite and Nitrate levels (exploratory outcome, TBD)
Time Frame: 16 weeks
Marker of treatment compliance
16 weeks
24h Urinary Potassium levels (exploratory outcome, TBD)
Time Frame: 16 weeks
Urine samples collected for estimation of potassium intake
16 weeks
24h Urinary Sodium levels (exploratory outcome, TBD)
Time Frame: 16 weeks
Urine samples collected for estimation of sodium intake
16 weeks
Cyclic guanosine monophosphate (cGMP) (exploratory outcome, TBD)
Time Frame: Baseline and 16 weeks
Change in cGMP vs. control at 16 weeks
Baseline and 16 weeks
Plasma nitrate/nitrite (exploratory outcome, TBD)
Time Frame: Baseline and 16 weeks
Change in plasma nitrate and nitrite vs. control at 16 weeks
Baseline and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DINO3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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