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Completed

NCT Number: NCT02916615

Effects of Nitrate in Vegetables on Blood Pressure in Subjects With Prehypertension

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 17177, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High nitrate vegetables

Other

vegetables naturally high in nitrate

Low nitrate vegetables + nitrate

Dietary Supplement

pill containing KNO3

Other names: potassium nitrate (KNO3)

Low nitrate vegetables

Other

vegetables naturally low in nitrate

Primary outcomes

  1. Difference in Change in ambulatory Systolic Blood Pressure From Baseline

    Time frame: 5 weeks intervention

    Measure how 24h ambulatory SBP changes over 5 weeks with the different interventions

Secondary outcomes

  1. Difference in Change in ambulatory diastolic Blood Pressure From Baseline

    Time frame: 5 weeks intervention

    Measure how 24h ambulatory DBP changes over 5 weeks with the different interventions

  2. Difference in Change in office diastolic blood pressure (DBP)

    Time frame: Once every week for 5 weeks

    BP is measured during a hospital visit every week during intervention

  3. Difference in Change in flow mediated dilatation (FMD)

    Time frame: 5 weeks intervention

    FMD is measured before and after the interventions

  4. Difference in Change in office Systolic Blood Pressure From Baseline

    Time frame: 5 weeks intervention

    Measure how clinic SBP changes weekly over 5 weeks with the different interventions

  5. Difference in Change in Daytime Ambulatory systolic Blood Pressure From Baseline

    Time frame: 5 weeks intervention

    Measure how 24h ambulatory daytime SBP changes over 5 weeks with the different interventions

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

Diet and Nitric Oxide (DINO): A Study on the Effects of Dietary Nitrate on Blood Pressure in Subjects With Prehypertension

Acronym: DINO

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2016
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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