Cardiovascular Disease, Hypertension
Conditions
Brief summary
The purpose of this study is to examine the effect of different vegetables on cardiovascular function in subjects with moderately increased blood pressure. Specifically we are comparing the effects of vegetables with a high natural content of inorganic nitrate with those of vegetables with a low nitrate content.
Detailed description
Recent studies indicate that dietary-derived inorganic nitrate can affect blood pressure in humans by converting into nitric oxide bioactivity. Here we will study if vegetables that naturally contain high amounts of nitrate (green leafy vegetables) can lower blood pressure and whether any effect is attributed to the nitrate anion. High nitrate vegetables are compared with vegetables low in nitrate (e.g. tomatoes, sweet pepper). After a 2 week run in period where all subjects receive vegetables low in nitrate, the participants are randomized to one of three interventions. One third of the patients receive high-nitrate vegetables + a placebo pill (KCl), one third receives low-nitrate vegetables + placebo and the third group receives low-nitrate vegetables + a nitrate pill (KNO3). The nitrate content in the pill is precisely matched to the nitrate content in the high-nitrate vegetable group.
Interventions
vegetables naturally high in nitrate
DIETARY_SUPPLEMENTLow nitrate vegetables + nitrate
pill containing KNO3
vegetables naturally low in nitrate
Sponsors
Karolinska University Hospital
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Age 50-70 years Systolic blood pressure \>130 at screening visit 2
Exclusion criteria
Systolic blood pressure \<120 or \>159 mm Hg at screening 2 Systolic blood pressure \> 169 mm Hg at screening 1 Chronic kidney disease Chronic rheumatic disease Insulin treated diabetes mellitus Atrial fibrillation Major cardiovascular event within 6 months Inflammatory bowel disease Malignancy, actively treated within 6 months Hepatitis Polycytemia Vera
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Change in ambulatory Systolic Blood Pressure From Baseline | 5 weeks intervention | Measure how 24h ambulatory SBP changes over 5 weeks with the different interventions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Change in ambulatory diastolic Blood Pressure From Baseline | 5 weeks intervention | Measure how 24h ambulatory DBP changes over 5 weeks with the different interventions |
| Difference in Change in office diastolic blood pressure (DBP) | Once every week for 5 weeks | BP is measured during a hospital visit every week during intervention |
| Difference in Change in flow mediated dilatation (FMD) | 5 weeks intervention | FMD is measured before and after the interventions |
| Difference in Change in office Systolic Blood Pressure From Baseline | 5 weeks intervention | Measure how clinic SBP changes weekly over 5 weeks with the different interventions |
| Difference in Change in Daytime Ambulatory systolic Blood Pressure From Baseline | 5 weeks intervention | Measure how 24h ambulatory daytime SBP changes over 5 weeks with the different interventions |
Countries
Sweden
Outcome results
None listed