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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High nitrate vegetables | Active Comparator | During 5 weeks subjects receive 100-150 g of a leafy green vegetable (High nitrate vegetables) per day and placebo pills containing 300 mg KCl (2 x 150 mg). |
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| Low nitrate vegetables | Placebo Comparator | During 5 weeks subjects receive 100-150 g of tomatoes/sweet pepper (Low nitrate vegetables) per day and placebo pills containing 300 mg KCl (2 x 150 mg). |
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| Low nitrate vegetables + nitrate | Active Comparator | During 5 weeks subjects receive 100-150 g of tomatoes/sweet pepper (Low nitrate vegetables) per day and nitrate pills containing 300 mg KNO3 (2 x 150 mg). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High nitrate vegetables | Other | vegetables naturally high in nitrate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Change in ambulatory Systolic Blood Pressure From Baseline | Measure how 24h ambulatory SBP changes over 5 weeks with the different interventions | 5 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Change in ambulatory diastolic Blood Pressure From Baseline | Measure how 24h ambulatory DBP changes over 5 weeks with the different interventions | 5 weeks intervention |
| Difference in Change in office diastolic blood pressure (DBP) |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jon Lundberg, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 17177 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41724486 | Derived | Bondonno CP, Sundqvist ML, Shinde S, Croft K, Hodgson JM, Carlstrom M, Weitzberg E, Lundberg JO. A clinical study examining the effects of dietary nitrate on urinary N-nitrosamines. Am J Clin Nutr. 2026 May;123(5):101239. doi: 10.1016/j.ajcnut.2026.101239. Epub 2026 Feb 20. | |
| 32091599 | Derived | Sundqvist ML, Larsen FJ, Carlstrom M, Bottai M, Pernow J, Hellenius ML, Weitzberg E, Lundberg JO. A randomized clinical trial of the effects of leafy green vegetables and inorganic nitrate on blood pressure. Am J Clin Nutr. 2020 Apr 1;111(4):749-756. doi: 10.1093/ajcn/nqaa024. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D009566 | Nitrates |
| C023844 | potassium nitrate |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017942 |
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| Low nitrate vegetables + nitrate |
| Dietary Supplement |
pill containing KNO3 |
|
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| Low nitrate vegetables | Other | vegetables naturally low in nitrate |
|
BP is measured during a hospital visit every week during intervention
| Once every week for 5 weeks |
| Difference in Change in flow mediated dilatation (FMD) | FMD is measured before and after the interventions | 5 weeks intervention |
| Difference in Change in office Systolic Blood Pressure From Baseline | Measure how clinic SBP changes weekly over 5 weeks with the different interventions | 5 weeks intervention |
| Difference in Change in Daytime Ambulatory systolic Blood Pressure From Baseline | Measure how 24h ambulatory daytime SBP changes over 5 weeks with the different interventions | 5 weeks intervention |
| Nitric Acid |
| D017672 | Nitrogen Compounds |
| D009930 | Organic Chemicals |