HypertensionPhase 3NCT03478631
Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors
A Phase 3 study testing High-nitrate dehydrated vegetable powder and Low-nitrate dehydrated vegetable powder in people with Hypertension and Blood Pressure, High, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hypertension, Blood Pressure, High
- What is being tested?
- High-nitrate dehydrated vegetable powder and Low-nitrate dehydrated vegetable powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2018to Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 18.5-35 kg/m2
- Seated systolic blood pressure ≥130 and <160 mmHg
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Elena Jovanovski, MSc, 416-864-6060 ext. 2597, JovanovskiE@smh.ca
Dandan Li, MSc (c), 416-864-6060 ext. 5527, LiDand@smh.ca
About this study
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
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.
Read the 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.
- Conditions
- Hypertension, Blood Pressure, High
- Being tested
- High-nitrate dehydrated vegetable powder, Low-nitrate dehydrated vegetable powder
- Keywords
- nitrate, vegetables
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-nitrate dehydrated vegetable powderOther
A mixed combination of vegetable powders that are naturally high in nitrate content, such as beet, spinach, and kale
Low-nitrate dehydrated vegetable powderOther
A mixed combination of vegetable powders that are naturally low in nitrate content, such as peas, tomato, broccoli, carrots, and brussel sprouts
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Low-nitrate dehydrated vegetable powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Change in systolic blood pressure vs. control at 16 weeks
Measured: Baseline, 8 and16 weeks
Secondary outcomes (6)
Mean 24h and Daytime Ambulatory Systolic, Diastolic and Mean Arterial Blood Pressure
Change in mean 24h and daytime ambulatory systolic, diastolic and mean arterial blood pressure vs. control at 16 weeks
Measured: Baseline and 16 weeks
Aortic Systolic and Diastolic Blood Pressure
Change in aortic systolic and diastolic blood pressure vs. control at 16 weeks
Measured: Baseline, 8 and 16 weeks
Pulse Wave Velocity (PWV)
Change in PWV vs. control at 16 weeks
Measured: Baseline and 16 weeks
Augmentation Index (AI)
Change in AI vs. control at 16 weeks
Measured: Baseline, 8 and 16 weeks
High Sensitivity C-reactive protein (hs-CRP)
Change in hs-CRP vs. control at 16 weeks
Measured: Baseline and 16 weeks
Plasma Lipids
Change in Total-C, LDL-C, HDL-C vs. control at 16 weeks
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study startAug 2018 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Vladimir Vuksan, Unity Health Toronto
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478631
- Sponsor's protocol ID
- DINO3
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03478631
- Acronym / sponsor ID
- DINO3
- Conditions
- Hypertension, Blood Pressure, High
- Keywords
- nitrate, vegetables
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2018 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| High Nitrate Dehydrated Vegetables | Experimental | Other: High-nitrate dehydrated vegetable powderParticipants 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. |
| Low-Nitrate Dehydrated Vegetables | Active comparator | Other: Low-nitrate dehydrated vegetable powderParticipants 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18.5-35 kg/m2
- Seated systolic blood pressure ≥130 and <160 mmHg
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-nitrate dehydrated vegetable powderA mixed combination of vegetable powders that are naturally high in nitrate content, such as beet, spinach, and kale | Other | High Nitrate Dehydrated Vegetables |
| Low-nitrate dehydrated vegetable powderA mixed combination of vegetable powders that are naturally low in nitrate content, such as peas, tomato, broccoli, carrots, and brussel sprouts | Other | Low-Nitrate Dehydrated Vegetables |
Primary outcome
Systolic Blood Pressure
Time frame: Baseline, 8 and16 weeks
Change in systolic blood pressure vs. control at 16 weeks
6 secondary outcomes
Mean 24h and Daytime Ambulatory Systolic, Diastolic and Mean Arterial Blood Pressure
Time frame: Baseline and 16 weeks
Aortic Systolic and Diastolic Blood Pressure
Time frame: Baseline, 8 and 16 weeks
Pulse Wave Velocity (PWV)
Time frame: Baseline and 16 weeks
Augmentation Index (AI)
Time frame: Baseline, 8 and 16 weeks
High Sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline and 16 weeks
Plasma Lipids
Time frame: Baseline and 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Vuksan, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High-nitrate dehydrated vegetable powder and Low-nitrate dehydrated vegetable powder in people with Hypertension and Blood Pressure, High, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Jovanovski, MSc (416 864 6060 ext. 2597, JovanovskiE@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Baseline, 8 and16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.