NCT04584372

Dietary Nitrate, Vascular Function and Inflammation

Completed NA Last updated 10 May 2023

What this trial tests

NA trial testing High-nitrate intervention in Hypertension in 20 participants. Completed in 28 March 2023.

Timeline

1 January 2021

Primary endpoint
28 March 2023

28 March 2023

Quick facts

Lead sponsor	University of Vienna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	1 January 2021
Primary completion	28 March 2023
Estimated completion	28 March 2023
Sites	2 locations across Austria

Drugs / interventions tested

• High-nitrate intervention
• Low-nitrate intervention

Conditions studied

• Hypertension — all drugs for Hypertension →
• Inflammation — all drugs for Inflammation →

Sponsor

University of Vienna

Who can join

Adults 55 to 75, any sex, with Hypertension or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The risk for cardiovascular diseases (CVD) increases with advancing age. Developing effective lifestyle-based strategies to promote, preserve or restore cardiovascular health with aging is a high priority. The overall aim of this clinical research is to investigate the innovative concept that an increased intake of dietary nitrate (through beetroot juice) could be a feasible adjuvant therapy to treat elevated blood pressure and improve blood vessel function in older adults.

Inorganic dietary nitrate, found in beetroot and green leafy vegetables, is a source of nitric oxide (NO), a signaling molecule that is important for cardiovascular health. NO is also produced in the human body, but the body's production and availability of NO decrease during ageing and CVD. The declined NO availability is associated with impaired blood vessel function, unresolved inflammatory responses, and an increased CVD risk. Dietary nitrate is an additional NO source. Following the intake of nitrate, NO is produced in a pathway that involves commensal bacteria in the mouth. So far, little is known about whether dietary nitrate improves cardiovascular health in older populations with high blood pressure.

The aim of this randomized, placebo-controlled crossover study is to investigate whether the daily intake of nitrate-rich beetroot juice over four weeks translates into improved cardiovascular health-related outcomes in older adults with treated mild high blood pressure. Men and women, between the ages of 55 and 70 years, who have been diagnosed with grade 1 high blood pressure and who are taking two or more blood-pressure lowering medications will be recruited. The study will investigate whether the increased dietary nitrate intake further lowers blood pressure and improves blood vessel function. A specific aim is to examine whether the nitrate intake results in favorable changes in the oral bacteria community and the systemic inflammatory status, and whether these changes correlate with cardiovascular-related outcomes. This research will offer information on the value of dietary nitrate to counteract chronic inflammation, the latter of which plays a role in developing or worsening cardiovascular disorders, such as high blood pressure.

The expected results of this study will provide important new evidence of whether nitrate-rich beetroot juice could be a key component of therapeutic interventions to improve cardiovascular health in individuals with high blood pressure.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nitric Oxide Signaling and Sensing in Age-Related Diseases.
   Mazuryk O, Gurgul I, Oszajca M, Polaczek J, et al · · 2024 · cited 14× · PMID 39456466 · DOI 10.3390/antiox13101213
2. Effects of increased nitrate intake from beetroot juice on blood markers of oxidative stress and inflammation in older adults with hypertension.
   Fejes R, Pilat N, Lutnik M, Weisshaar S, et al · · 2024 · cited 12× · PMID 38972612 · DOI 10.1016/j.freeradbiomed.2024.07.004
3. Increased nitrate intake from beetroot juice over 4 weeks affects nitrate metabolism, but not vascular function or blood pressure in older adults with hypertension.
   Fejes R, Lutnik M, Weisshaar S, Pilat N, et al · · 2024 · cited 6× · PMID 38546454 · DOI 10.1039/d3fo03749e
4. Increased Nitrate Intake From Beetroot Juice Over 4 Weeks Changes the Composition of the Oral, But Not the Intestinal Microbiome.
   Fejes R, Séneca J, Pjevac P, Lutnik M, et al · · 2025 · cited 5× · PMID 40522148 · DOI 10.1002/mnfr.70156