Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors

NCT03478631 | Unknown Phase 3 DMC

• 1 other identifier: DINO3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Blood Pressure, High

Keywords

nitrate; vegetables

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  Change in systolic blood pressure vs. control at 16 weeks

  Baseline, 8 and16 weeks

Secondary Outcomes (6)

• Mean 24h and Daytime Ambulatory Systolic, Diastolic and Mean Arterial Blood Pressure

  Baseline and 16 weeks

• Aortic Systolic and Diastolic Blood Pressure

  Baseline, 8 and 16 weeks

• Pulse Wave Velocity (PWV)

  Baseline and 16 weeks

• Augmentation Index (AI)

  Baseline, 8 and 16 weeks

• High Sensitivity C-reactive protein (hs-CRP)

  Baseline and 16 weeks

Other Outcomes (13)

• Symptoms Diary

  Screening, baseline, 8 and 16 weeks

• Aspartate Aminotransferase (AST)

  Screening, baseline, 8 and 16 weeks

• Creatinine

  Screening, baseline, 8 and 16 weeks

Study Arms (2)

High Nitrate Dehydrated Vegetables

EXPERIMENTAL

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

Low-Nitrate Dehydrated Vegetables

ACTIVE COMPARATOR

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

Interventions

High-nitrate dehydrated vegetable powder OTHER

A mixed combination of vegetable powders that are naturally high in nitrate content, such as beet, spinach, and kale

High Nitrate Dehydrated Vegetables

Low-nitrate dehydrated vegetable powder OTHER

A mixed combination of vegetable powders that are naturally low in nitrate content, such as peas, tomato, broccoli, carrots, and brussel sprouts

Low-Nitrate Dehydrated Vegetables

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vladimir Vuksan, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Jovanovski, MSc

CONTACT

416 864 6060; JovanovskiE@smh.ca

Dandan Li, MSc (c)

CONTACT

416 864 6060; LiDand@smh.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)