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Trial record 12 of 528 for:    NITRATE ION

Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors

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ClinicalTrials.gov Identifier: NCT03478631
Recruitment Status : Not yet recruiting
First Posted : March 27, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Vladimir Vuksan, St. Michael's Hospital, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Blood Pressure, High Other: High-nitrate dehydrated vegetable powder Other: Low-nitrate dehydrated vegetable powder Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a randomized, double-blind, controlled parallel study. There will be two experimental arms of 16-week duration, in which participants are assigned to test or control arms under free living conditions in an outpatient setting.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants and study coordinators will be blinded to the nature of the treatment allocation. Stratified randomization lists by baseline sex and age will be created.
Primary Purpose: Treatment
Official Title: The Role of Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors: a Randomized, Controlled Trial in Individuals With Elevated Blood Pressure
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: Baseline, 8 and16 weeks ]
    Change in systolic blood pressure vs. control at 16 weeks


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Pulse Wave Velocity (PWV) [ Time Frame: Baseline and 16 weeks ]
    Change in PWV vs. control at 16 weeks

  4. Augmentation Index (AI) [ Time Frame: Baseline, 8 and 16 weeks ]
    Change in AI vs. control at 16 weeks

  5. High Sensitivity C-reactive protein (hs-CRP) [ Time Frame: Baseline and 16 weeks ]
    Change in hs-CRP vs. control at 16 weeks

  6. Plasma Lipids [ Time Frame: Baseline and 16 weeks ]
    Change in Total-C, LDL-C, HDL-C vs. control at 16 weeks


Other Outcome Measures:
  1. Symptoms Diary [ Time Frame: Screening, baseline, 8 and 16 weeks ]
    Record of any adverse symptoms experienced and the level of severity

  2. Aspartate Aminotransferase (AST) [ Time Frame: Screening, baseline, 8 and 16 weeks ]
    Liver function test

  3. Creatinine [ Time Frame: Screening, baseline, 8 and 16 weeks ]
    Kidney function test

  4. Sachet Count [ Time Frame: 8 and 16 weeks ]
    Record of the amount of sachets and contents returned

  5. 7-Day Food Record [ Time Frame: Baseline, 8 and 16 weeks ]
    Record of food intake 7 days prior to study visit day

  6. 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

  7. Habitual Physical Activity Questionnaire [ Time Frame: Baseline, Week 16 ]
    Questions to assess level of physical activity

  8. Body Weight [ Time Frame: Screening, baseline, 8 and 16 weeks ]
    Body Weight in kg

  9. 24h Urinary Nitrite and Nitrate levels (exploratory outcome, TBD) [ Time Frame: 16 weeks ]
    Marker of treatment compliance

  10. 24h Urinary Potassium levels (exploratory outcome, TBD) [ Time Frame: 16 weeks ]
    Urine samples collected for estimation of potassium intake

  11. 24h Urinary Sodium levels (exploratory outcome, TBD) [ Time Frame: 16 weeks ]
    Urine samples collected for estimation of sodium intake

  12. Cyclic guanosine monophosphate (cGMP) (exploratory outcome, TBD) [ Time Frame: Baseline and 16 weeks ]
    Change in cGMP vs. control at 16 weeks

  13. Plasma nitrate/nitrite (exploratory outcome, TBD) [ Time Frame: Baseline and 16 weeks ]
    Change in plasma nitrate and nitrite vs. control at 16 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478631


Contacts
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Contact: Elena Jovanovski, MSc 416 864 6060 ext 2597 JovanovskiE@smh.ca
Contact: Dandan Li, MSc (c) 416 864 6060 ext 5527 LiDand@smh.ca

Locations
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Canada, Ontario
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Elena Jovanovski, MSc    416-864-6060 ext 2597    JovanovskiE@smh.ca   
Contact: Dandan Li, MSc (c)    416-864-6060 ext 5527    LiDand@smh.ca   
Principal Investigator: Vladimir Vuksan, PhD         
Sub-Investigator: John Sievenpiper (Qualified Investigator), MD, PhD         
Sub-Investigator: Verma Subodh, MD,FRCSC,PhD         
Sub-Investigator: David Jenkins, MD, PhD, DSc         
Sub-Investigator: Alexandra Jenkins, PhD, RD         
Sub-Investigator: Elena Jovanovski, MSc, PhD (c)         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Vladimir Vuksan, PhD St. Michael's Hospital, Toronto

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Responsible Party: Vladimir Vuksan, Professor, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03478631     History of Changes
Other Study ID Numbers: DINO3
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vladimir Vuksan, St. Michael's Hospital, Toronto:
nitrate
vegetables
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases