A 2 Week, Crossover Trial of Dietary Nitrate in HTN

Royal College of Surgeons, Ireland

Status: Completed

Conditions: Hypertension

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Dietary nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02597010

Chronic NO3- in HTN

Details and patient eligibility

About

Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations including newly diagnosed, untreated hypertensives. The additional effect in hypertensives on blood pressure lowering medications is uncertain.

Full description

Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations including newly diagnosed, untreated hypertensives. The additional effect in hypertensives on blood pressure lowering medications is uncertain.

The investigators hypothesize that chronic nitrate consumption might decrease blood pressure in hypertensives who are suboptimally controlled on at least one blood pressure medication compared to a placebo beetroot juice.

This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 7 consecutive days when assessments will be repeated followed by 7 days of placebo and endpoint assessments or the converse.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically stable,
• Uncontrolled hypertension

Exclusion criteria

• Pulmonary hypertension
• Active CVD
• Taking vasodilators
• Diabetes mellitus

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

20 participants in 2 patient groups, including a placebo group

Nitrate rich beetroot juice

Experimental group

Description:

Concentrated, beetroot juice is a rich source of dietary nitrate.

Treatment:

Dietary Supplement: Dietary nitrate

Nitrate depleted placebo beetroot juice

Placebo Comparator group

Description:

Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.

Treatment:

Dietary Supplement: Placebo