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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

High nitrate vegetables

Intervention Type OTHER

vegetables naturally high in nitrate

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).

Group Type PLACEBO_COMPARATOR

Low nitrate vegetables

Intervention Type OTHER

vegetables naturally low in nitrate

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).

Group Type ACTIVE_COMPARATOR

Low nitrate vegetables + nitrate

Intervention Type DIETARY_SUPPLEMENT

pill containing KNO3

Interventions

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High nitrate vegetables

vegetables naturally high in nitrate

Intervention Type OTHER

Low nitrate vegetables + nitrate

pill containing KNO3

Intervention Type DIETARY_SUPPLEMENT

Low nitrate vegetables

vegetables naturally low in nitrate

Intervention Type OTHER

Other Intervention Names

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potassium nitrate (KNO3)

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes