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Effects of Nitrate in Vegetables on Blood Pressure in Subjects With Prehypertension (DINO)

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ClinicalTrials.gov Identifier: NCT02916615
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Jon Lundberg, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Disease Other: High nitrate vegetables Dietary Supplement: Low nitrate vegetables + nitrate Other: Low nitrate vegetables Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Diet and Nitric Oxide (DINO): A Study on the Effects of Dietary Nitrate on Blood Pressure in Subjects With Prehypertension
Study Start Date : January 2016
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Active Comparator: High nitrate vegetables
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).
Other: High nitrate vegetables
vegetables naturally high in nitrate

Placebo Comparator: Low nitrate vegetables
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).
Other: Low nitrate vegetables
vegetables naturally low in nitrate

Active Comparator: Low nitrate vegetables + nitrate
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).
Dietary Supplement: Low nitrate vegetables + nitrate
pill containing KNO3
Other Name: potassium nitrate (KNO3)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916615


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
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Principal Investigator: Jon Lundberg, MD, PhD Karolinska Institutet

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Responsible Party: Jon Lundberg, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02916615     History of Changes
Other Study ID Numbers: DINO1
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prehypertension
Cardiovascular Diseases
Vascular Diseases