HealthyPhase 2DNABNCT01604993
Acute Effect of Nitrate From Natural Dietary Sources on Arterial Stiffness and Blood Pressures in Healthy Individuals
A Phase 2 study testing Spinach soup and Asparagus soup in people with Healthy, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates on aortic augmentation index, brachial and aortic blood pressures, and subendocardial viability ration (SEVR). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Spinach soup and Asparagus soup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Oct 2013
- Phase
- Phase 2
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 18-50
- Must consider themselves to be in good overall health and be free of any conditions or illnesses Women must be post-menopausal or not pregnant.
- Body mass index (BMI) must be <30kg/m^2.
- Normotensive, as defined by brachial SBP <140mmHg and DBP <90mmHg
- Subjects must also be willing to stop using mouthwash for the duration of their participation in the study.
Who cannot join
- Women of childbearing age may not be pregnant, planning to become pregnant, or breastfeeding at the time of the study
- BMI >30kg/m^2
- Hypertensive as defined by brachial SBP >140mmHg and/or DBP >90mmHg
- Allergy or sensitivity to the study product, reference therapy or nitrates
- Having any gastrointestinal complication or condition
- Chronic use of medications such as prescription NSAIDs, antacids, blood-thinners, hypertensive medications, medications affecting NO synthesis such as Viagra, and use of antibiotics within one month of the study start
- Individuals who are involved in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Nitrate Supplementation From Natural Dietary Sources on Arterial Stiffness and Aortic and Brachial Blood Pressures: a Double-blind, Placebo-controlled, Randomized, Crossover Clinical Trial in Healthy Adults
The purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates on aortic augmentation index, brachial and aortic blood pressures, and subendocardial viability ration (SEVR).
Read the detailed description
Hypertension has become a common medical condition worldwide, raising public concern regarding the accompanying increase in cardiovascular disease risk and other health risks. Targets for optimal blood pressure are often unmet by conventional pharmaceutical therapies; consequently, complementary and alternative medicines are increasing in popularity among patients wishing to better manage their BP. In the case of hypertension, endothelial dysfunction and cardiovascular disease, a decline in the ability of blood vessels to dilate in response to shear stress is a major contributor to vascular pathology. At the core of these conditions is a decreased ability to synthesize nitric oxide, a potent vasodilatory agent. The proposed study will examine whether or not increasing the intake of dietary nitrate, which can be converted to nitric oxide endogenously, can improve three indices of vascular function that are validated risk factors for CVD: arterial stiffness, as measured by aortic augmentation index (AIx), aortic BP and brachial BP.
- Conditions
- Healthy
- Being tested
- Spinach soup, Asparagus soup
- Keywords
- Dietary Nitrates, Arterial Stiffness, Vascular, Blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinach soupOther
556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days
Asparagus soupOther
556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does
| Study group | Role | What they receive |
|---|---|---|
| High nitrate dietary source | Experimental | 556 grams of high nitrate spinach soup that is orally consumed as a single dose for 7 days. Receives: Other: Spinach soup |
| No Nitrate dietary source | Placebo comparator | 556g low nitrate asparagus soup; orally consumed as a single does for 7 days. Receives: Other: Asparagus soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic augmentation index (arterial stiffness)
Measured: At each treatment visits, this measurement will be taken in at baseline, 1, 2, and 3 hours post-treatment.
Secondary outcomes (2)
Peripheral (brachial) and central (aortic) systolic and diastolic blood pressure
Measured: Brachial blood pressure will be measured at 0 , 1, 2, and 3 hours post -treatmentbaseline and at 1, 2 and 3 hours at every visit.
Subendocardial viability ratio (SEVR)
Measured: At 1 hours intervals starting from baseline and ending at 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Risk Factor Modification Centre - St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604993
- Sponsor's protocol ID
- 11216
- Acronym
- DNAB
- Status last verified
- Mar 2014
- First submitted
- 22 May 2012
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Nitrate Supplementation From Natural Dietary Sources on Arterial Stiffness and Aortic and Brachial Blood Pressures: a Double-blind, Placebo-controlled, Randomized, Crossover Clinical Trial in Healthy Adults
- ClinicalTrials.gov ID
- NCT01604993
- Acronym / sponsor ID
- DNAB / 11216
- Conditions
- Healthy
- Keywords
- Dietary Nitrates, Arterial Stiffness, Vascular, Blood pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 May 2012 (estimated)
- 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 purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates on aortic augmentation index, brachial and aortic blood pressures, and subendocardial viability ration (SEVR).
Detailed description
Hypertension has become a common medical condition worldwide, raising public concern regarding the accompanying increase in cardiovascular disease risk and other health risks. Targets for optimal blood pressure are often unmet by conventional pharmaceutical therapies; consequently, complementary and alternative medicines are increasing in popularity among patients wishing to better manage their BP. In the case of hypertension, endothelial dysfunction and cardiovascular disease, a decline in the ability of blood vessels to dilate in response to shear stress is a major contributor to vascular pathology. At the core of these conditions is a decreased ability to synthesize nitric oxide, a potent vasodilatory agent. The proposed study will examine whether or not increasing the intake of dietary nitrate, which can be converted to nitric oxide endogenously, can improve three indices of vascular function that are validated risk factors for CVD: arterial stiffness, as measured by aortic augmentation index (AIx), aortic BP and brachial BP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High nitrate dietary source | Experimental | Other: Spinach soup556 grams of high nitrate spinach soup that is orally consumed as a single dose for 7 days. |
| No Nitrate dietary source | Placebo comparator | Other: Asparagus soup556g low nitrate asparagus soup; orally consumed as a single does for 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers aged 18-50
- Must consider themselves to be in good overall health and be free of any conditions or illnesses Women must be post-menopausal or not pregnant.
- Body mass index (BMI) must be <30kg/m^2.
- Normotensive, as defined by brachial SBP <140mmHg and DBP <90mmHg
- Subjects must also be willing to stop using mouthwash for the duration of their participation in the study.
Key exclusion criteria (7 listed)
- Women of childbearing age may not be pregnant, planning to become pregnant, or breastfeeding at the time of the study
- BMI >30kg/m^2
- Hypertensive as defined by brachial SBP >140mmHg and/or DBP >90mmHg
- Allergy or sensitivity to the study product, reference therapy or nitrates
- Having any gastrointestinal complication or condition
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 |
|---|---|---|
| Spinach soup556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days | Other | High nitrate dietary source |
| Asparagus soup556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does | Other | No Nitrate dietary source |
Primary outcome
Aortic augmentation index (arterial stiffness)
Time frame: At each treatment visits, this measurement will be taken in at baseline, 1, 2, and 3 hours post-treatment.
2 secondary outcomes
Peripheral (brachial) and central (aortic) systolic and diastolic blood pressure
Time frame: Brachial blood pressure will be measured at 0 , 1, 2, and 3 hours post -treatmentbaseline and at 1, 2 and 3 hours at every visit.
Subendocardial viability ratio (SEVR)
Time frame: At 1 hours intervals starting from baseline and ending at 3 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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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
Risk Factor Modification Centre - St. Michael's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spinach soup and Asparagus soup in people with Healthy, 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 10 Mar 2014. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic augmentation index (arterial stiffness) (time frame: At each treatment visits, this measurement will be taken in at baseline, 1, 2, and 3 hours post-treatment.). 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 10 Mar 2014.