NCT07290842

The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Gødstrup Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study aims to study the effects of diatery nitrate in patients with hypertension and hypertensive kidney injury. The study is a randomized, placebo-controlled, double-blinded crossover trial. 14-20 patients with hypertension and CKD I-III will be randomized to receive either nitrate or placebo delivered in the form of beetroot juice. Effect variables will be measured before and after a 2 week treatment. After a washout period of 14 days, the subjects are crossed over to the opposite treatment. The study is terminated by measuring effect variables after the second treatment period.

Detailed description

AIM: We aim to investigate the mechanisms behind the cardiovascular and renal effect of nitrates in patients with hypertension and hypertensive kidney injury. HYPOTHESIS: Dietary nitrate decreases BP and increases renal blood flow. This is independent of renal function or enhanced during low eGFR due to reduced renal clearance of nitrate. METHODS: The study is a randomized, placebo-controlled, double-blinded crossover trial. 14-20 patients with hypertension and CKD I-III will be randomized to receive either nitrate or placebo delivered in the form of beetroot juice. Effect variables will be measured before and after a 2 week treatment. After each treatment period effect variables will be measured, including include 24 hour bloodpressure measurment. Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT) is performed only after the intervention periods. After a washout period of 14 days, the subjects are crossed over to the opposite treatment. The study is terminated by measuring effect variables after the second treatment period. PERSPECTIVE: The knowledge gained from these studies can lead to improved dietary counselling, which is a promising approach in the treatment of hypertension.

Conditions

• Hypertension
• CKD - Chronic Kidney Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Beetroot Juice - Active	Intervention is beetroot juice ("Beet It concentrated beetroot juice shots", James White Drinks Ltd, Ipswich, England) The nitrate content of the juice is standardized. The dose of nitrate will be 70 ml/day corresponding to intake of 6.5 mmol/400 mg of nitrate.
DIETARY_SUPPLEMENT	Beetroot juice placebo	The placebo beetroot juice is a corresponding nitrate free beetroot juice, obtained from the manufacturer ("Beet It nitrate depleted shots", James White Drinks Ltd, Ipswich, England.). The placebo juice appears identical to the nitrate containing juice regarding color and taste.

Timeline

• Start date: 2025-12-08
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: Denmark