Hypertension Clinical Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
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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