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

Hypertension Clinical Trial

— DINO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916615
• Other study ID #: DINO1
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 30, 2019

Study information

• Verified date: March 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension
• Prehypertension

Intervention

Other:
• High nitrate vegetables
vegetables naturally high in nitrate

Dietary Supplement:
• Low nitrate vegetables + nitrate
pill containing KNO3

Other:
• Low nitrate vegetables
vegetables naturally low in nitrate

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in Change in ambulatory diastolic Blood Pressure From Baseline	Measure how 24h ambulatory DBP changes over 5 weeks with the different interventions	5 weeks intervention
Secondary	Difference in Change in office diastolic blood pressure (DBP)	BP is measured during a hospital visit every week during intervention	Once every week for 5 weeks
Secondary	Difference in Change in flow mediated dilatation (FMD)	FMD is measured before and after the interventions	5 weeks intervention
Secondary	Difference in Change in office Systolic Blood Pressure From Baseline	Measure how clinic SBP changes weekly over 5 weeks with the different interventions	5 weeks intervention
Secondary	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	5 weeks intervention