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

Primary Purpose

Hypertension, Cardiovascular Disease

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

High nitrate vegetables

Low nitrate vegetables + nitrate

Low nitrate vegetables

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

High nitrate vegetables

Low nitrate vegetables

Low nitrate vegetables + nitrate

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Difference in Change in ambulatory Systolic Blood Pressure From Baseline

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

Secondary Outcome Measures

Difference in Change in ambulatory diastolic Blood Pressure From Baseline

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

Difference in Change in office diastolic blood pressure (DBP)

BP is measured during a hospital visit every week during intervention

Difference in Change in flow mediated dilatation (FMD)

FMD is measured before and after the interventions

Difference in Change in office Systolic Blood Pressure From Baseline

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

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

Full Information

NCT ID

NCT02916615

First Posted

September 26, 2016

Last Updated

March 21, 2019

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02916615

Brief Title

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

Acronym

DINO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

January 30, 2019 (Actual)

Study Completion Date

January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Cardiovascular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

225 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High nitrate vegetables

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Low nitrate vegetables

Arm Type

Placebo Comparator

Arm Description

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).

Arm Title

Low nitrate vegetables + nitrate

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Other

Intervention Name(s)

High nitrate vegetables

Intervention Description

vegetables naturally high in nitrate

Intervention Type

Dietary Supplement

Intervention Name(s)

Low nitrate vegetables + nitrate

Other Intervention Name(s)

potassium nitrate (KNO3)

Intervention Description

pill containing KNO3

Intervention Type

Other

Intervention Name(s)

Low nitrate vegetables

Intervention Description

vegetables naturally low in nitrate

Primary Outcome Measure Information:

Title

Difference in Change in ambulatory Systolic Blood Pressure From Baseline

Description

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

Time Frame

5 weeks intervention

Secondary Outcome Measure Information:

Title

Difference in Change in ambulatory diastolic Blood Pressure From Baseline

Description

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

Time Frame

5 weeks intervention

Title

Difference in Change in office diastolic blood pressure (DBP)

Description

BP is measured during a hospital visit every week during intervention

Time Frame

Once every week for 5 weeks

Title

Difference in Change in flow mediated dilatation (FMD)

Description

FMD is measured before and after the interventions

Time Frame

5 weeks intervention

Title

Difference in Change in office Systolic Blood Pressure From Baseline

Description

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

Time Frame

5 weeks intervention

Title

Difference in Change in Daytime Ambulatory systolic Blood Pressure From Baseline

Description

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

Time Frame

5 weeks intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jon Lundberg, MD, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska Institutet

City

Stockholm

ZIP/Postal Code

17177

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32091599

Citation

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.

Results Reference

derived

Learn more about this trial

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

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