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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03478631
Other study ID # DINO3
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received March 20, 2018
Last updated March 26, 2018
Start date August 2018
Est. completion date August 2020

Study information

Verified date March 2018
Source St. Michael's Hospital, Toronto
Contact Elena Jovanovski, MSc
Phone 416 864 6060
Email JovanovskiE@smh.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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 Design


Intervention

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
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

Locations

Country Name City State
Canada Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Symptoms Diary Record of any adverse symptoms experienced and the level of severity Screening, baseline, 8 and 16 weeks
Other Aspartate Aminotransferase (AST) Liver function test Screening, baseline, 8 and 16 weeks
Other Creatinine Kidney function test Screening, baseline, 8 and 16 weeks
Other Sachet Count Record of the amount of sachets and contents returned 8 and 16 weeks
Other 7-Day Food Record Record of food intake 7 days prior to study visit day Baseline, 8 and 16 weeks
Other Nitrate Food Frequency Questionnaire Assess consumption of nitrate-rich meats and vegetables Biweekly (screening, 0,2,4,6,8,10,12,14,16,18 weeks)
Other Habitual Physical Activity Questionnaire Questions to assess level of physical activity Baseline, Week 16
Other Body Weight Body Weight in kg Screening, baseline, 8 and 16 weeks
Other 24h Urinary Nitrite and Nitrate levels (exploratory outcome, TBD) Marker of treatment compliance 16 weeks
Other 24h Urinary Potassium levels (exploratory outcome, TBD) Urine samples collected for estimation of potassium intake 16 weeks
Other 24h Urinary Sodium levels (exploratory outcome, TBD) Urine samples collected for estimation of sodium intake 16 weeks
Other Cyclic guanosine monophosphate (cGMP) (exploratory outcome, TBD) Change in cGMP vs. control at 16 weeks Baseline and 16 weeks
Other Plasma nitrate/nitrite (exploratory outcome, TBD) Change in plasma nitrate and nitrite vs. control at 16 weeks Baseline and 16 weeks
Primary Systolic Blood Pressure Change in systolic blood pressure vs. control at 16 weeks Baseline, 8 and16 weeks
Secondary 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 Baseline and 16 weeks
Secondary Aortic Systolic and Diastolic Blood Pressure Change in aortic systolic and diastolic blood pressure vs. control at 16 weeks Baseline, 8 and 16 weeks
Secondary Pulse Wave Velocity (PWV) Change in PWV vs. control at 16 weeks Baseline and 16 weeks
Secondary Augmentation Index (AI) Change in AI vs. control at 16 weeks Baseline, 8 and 16 weeks
Secondary High Sensitivity C-reactive protein (hs-CRP) Change in hs-CRP vs. control at 16 weeks Baseline and 16 weeks
Secondary Plasma Lipids Change in Total-C, LDL-C, HDL-C vs. control at 16 weeks Baseline and 16 weeks
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