NCT02916615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

3.1 years

First QC Date

September 26, 2016

Last Update Submit

March 21, 2019

Conditions

HypertensionCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Difference in Change in ambulatory diastolic Blood Pressure From Baseline

    5 weeks intervention

  • Difference in Change in office diastolic blood pressure (DBP)

    Once every week for 5 weeks

  • Difference in Change in flow mediated dilatation (FMD)

    5 weeks intervention

  • Difference in Change in office Systolic Blood Pressure From Baseline

    5 weeks intervention

  • Difference in Change in Daytime Ambulatory systolic Blood Pressure From Baseline

    5 weeks intervention

Study Arms (3)

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).

Other: High nitrate vegetables

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).

Other: Low nitrate vegetables

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).

Dietary Supplement: Low nitrate vegetables + nitrate

Interventions

High nitrate vegetablesOTHER

vegetables naturally high in nitrate

High nitrate vegetables
Low nitrate vegetables + nitrateDIETARY_SUPPLEMENT

pill containing KNO3

Also known as: potassium nitrate (KNO3)
Low nitrate vegetables + nitrate
Low nitrate vegetablesOTHER

vegetables naturally low in nitrate

Low nitrate vegetables

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-70 years Systolic blood pressure \>130 at screening visit 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 32091599DERIVED

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Interventions

Nitratespotassium nitrate

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic Chemicals

Study Officials

  • Jon Lundberg, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 27, 2016

Study Start

January 1, 2016

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

SE(1)