HypertensionNCT04584372
Dietary Nitrate, Vascular Function and Inflammation
A study testing High-nitrate intervention and Low-nitrate intervention in people with Hypertension and Inflammation, run by University of Vienna at 2 sites in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Hypertension, Inflammation
- What is being tested?
- High-nitrate intervention and Low-nitrate intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Jan 2021to 28 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulant male and females between 55 and 75 years of age, inclusive
- Resting systolic blood pressure between 130 and 170 mmHg, inclusive
- Written informed consent
Who cannot join
- Diastolic blood pressure >110 mmHg
- Type 1 or 2 diabetes mellitus or fasting glucose >7.0 mmol/L
- Any evidence of acute or chronic disease such as symptomatic cardiovascular or peripheral vascular disease, moderate or severe chronic kidney disease (estimated glomerular filtration rate (GFR) <50 ml/min)), or cancer which is not in remission
- Consumption of ≥5 serves of vegetables per day
- Consumption of a diet estimated to contain >200 mg/d of nitrate
- Being vegan or vegetarian
Show all 17Show fewer
- BMI ≥35 kg/m2 or <18.5 kg/m2
- Use of nitric oxide donors, organic nitrites/nitrates, sildenafil and related drugs, anti-coagulation, non-steroidal anti-inflammatory or statin-related drugs
- Use of antibacterial mouthwash (volunteers willing to cease using antibacterial mouth wash for a period of 4 weeks before randomisation will be included)
- Use of antibiotics (within previous 2 months)
- A change in drug therapy likely to influence blood pressure or major secondary outcomes within the previous month, or the likelihood that drug therapy would change during the study
- Current or recent (within previous 3 months) engagement in regular structured exercise training (more than 2 hours of moderate to more intense exercise per week)
- Current or recent (within previous 6 months) loss or gain of >6% of body weight
- Current or recent (<12 months) regular smoking of >5 cigarettes/day
- Alcohol intake >140 g per week for women or >210 g per week for men and/or binge drinking behaviour
- Inability or unwillingness to follow the study protocol
- Pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University of Vienna
Vienna, 1090
University of Vienna
Vienna, 1090
About this study
Official title: Effects of Dietary Nitrate on Vascular Function, Blood Pressure, the Oral Microbiome, and Biomarkers of Systemic Inflammation in Hypertensive Older Adults: a Randomized, Placebo-controlled Crossover Study
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.
Read more
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.
Read the detailed description
This clinical research is funded by the Austrian Science Fund (FWF, project number: KLI 858). It is based on close collaborations between the University of Vienna and the Medical University of Vienna, with the Department of Clinical Pharmacology at the Medical University of Vienna as the clinical trial center and Prof. M.D. Michael Wolzt as the trial center's coordinating physician. The sponsor is the University of Vienna, as represented by the Principal Investigator Dr. Oliver Neubauer (Research Platform Active Ageing). International collaborations include Dr. Catherine Bondonno, Prof. Hodgson (both Edith Cowan University) Dr. Jonathan Peake (Queensland University of Technology), and Prof. Richard Woodman (Flinders University) (all Australia).
Wider research context / theoretical framework:
Aging is a major risk factor for cardiovascular disease (CVD). Developing effective strategies to improve cardiovascular health with ageing is a high priority. Emerging data indicate that inorganic dietary nitrate, found in green leafy vegetables and beetroot juice (BRJ), is important for cardiovascular health (Blekkenhorst et al. 2018). These data suggest that small increases in nitrate intake among those with elevated risk for CVD would have a substantial impact, by improving the bioavailability of nitric oxide (NO) through the enterosalivary nitrate- nitrite-NO pathway (involving the oral microbiome). Results from the study group's research suggest beneficial short-term effects of nitrate-rich BRJ on blood pressure and vascular inflammation markers in healthy older adults (Raubenheimer et al. 2017).
Hypotheses / research questions / objectives:
The proposed clinical study is aimed to examine whether the daily consumption of 2×70 mL BRJ over 4 weeks translates into improved clinical outcomes in older adults with treated grade 1 hypertension. The primary hypothesis is that the increased dietary nitrate intake lowers blood pressure and improves vascular function. The secondary hypotheses are that the increased dietary nitrate intake results in changes in the oral microbiome, favorably modulates the systemic inflammatory status, and that these changes correlate with cardiovascular-related outcomes.
Approach / methods:
This randomized, placebo-controlled crossover study will involve two 4-week treatment periods, consisting of interventions with nitrate-rich BRJ and nitrate-depleted BRJ, separated by a 4-week washout period. Thirty-five men and women, between the ages of 55 and 70 years, who have been diagnosed with grade 1 hypertension will be recruited. Twenty-nine participants will be required to complete the study, based on power/sample size calculations with the forearm blood flow (FBF) response to acetylcholine and 24 h-ambulatory systolic blood pressure as the primary endpoints. Principal secondary endpoints are the number of CD11b-expressing blood granulocytes and the FBF response to glyceryltrinitrate. Among various additional secondary and exploratory endpoints, plasma nitrate and nitrite and a broad range of inflammation biomarkers will be measured. Furthermore, the oral microbiome will be analyzed.
Level of originality / innovation:
Beneficial effects of nitrate have predominantly been observed in healthy populations, but evidence of cardiovascular benefits and anti-inflammatory effects in clinical populations is limited (Raubenheimer et al. 2019). This study addresses the need to determine the efficacy of dietary nitrate to improve cardiovascular health and counteract chronic low-grade inflammation in humans at risk of CVD.
- Conditions
- Hypertension, Inflammation
- Being tested
- High-nitrate intervention, Low-nitrate intervention
- Keywords
- dietary nitrate, inorganic nitrate-nitrite-nitric oxide pathway, oral microbiome, chronic low-grade inflammation, vascular integrity, high blood pressure, cardiovascular health
- Medical subject headings
- Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-nitrate interventionDietary supplement
Also called HI-NI
The 2×70 mL of nitrate-rich (i.e., 'high nitrate') beetroot juice contains 12.9 mmol nitrate (NO3-).
Low-nitrate interventionDietary supplement
Also called LO-NI
The 2×70 mL of nitrate-depleted (i.e., 'low nitrate') beetroot juice contains 0.04 mmol (or less) nitrate.
| Study group | Role | What they receive |
|---|---|---|
| High-nitrate (HI-NI) intervention | Active comparator | The 'active treatment' arm will involve daily consumption of 2×70 mL nitrate-rich (HI-NI) beetroot juice (70 mL with breakfast and 70 mL with dinner) over an intervention period of 4 weeks. Receives: Dietary Supplement: High-nitrate intervention |
| Low-nitrate (LO-NI) intervention | Placebo comparator | The placebo treatment arm daily consumption of 2×70 mL nitrate-depleted (LO-NI) beetroot juice (70 mL with breakfast and 70 mL with dinner) an intervention period of 4 weeks. Receives: Dietary Supplement: Low-nitrate intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forearm blood flow (FBF) response to acetylcholine
Vascular function
Measured: Change from baseline FBF at 4 weeks of the HI-NI intervention
Change in forearm blood flow (FBF) response to acetylcholine
Vascular function
Measured: Change from baseline FBF at 4 weeks of the LO-NI intervention
Change in 24 hour-ambulatory systolic blood pressure
Blood pressure
Measured: Change from baseline 24 hour-ambulatory systolic blood pressure at 4 weeks of the HI-NI intervention
Change in 24 hour-ambulatory systolic blood pressure
Blood pressure
Measured: Change from baseline 24 hour-ambulatory systolic blood pressure at 4 weeks of the LO-NI intervention
Secondary outcomes (4)
Change in granulocyte CD11b expression
Vascular inflammation biomarker
Measured: Change from baseline granulocyte CD11b expression at 4 weeks of the HI-NI intervention
Change in granulocyte CD11b expression
Vascular inflammation biomarker
Measured: Change from baseline granulocyte CD11b expression at 4 weeks of the LO-NI intervention
Change in forearm blood flow (FBF) response to glyceryltrinitrate
Vascular function
Measured: Change from baseline FBF at 4 weeks of the HI-NI intervention
Change in forearm blood flow (FBF) response to glyceryltrinitrate
Vascular function
Measured: Change from baseline FBF at 4 weeks of the LO-NI intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jan 2021
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, mono-center, randomized, double-blind, placebo-controlled, crossover study The study will involve a randomized, placebo-controlled crossover design, with two 4-week treatment periods separated by a 4-week washout period. The two treatments will consist of a 4-week high-nitrate (HI-NI) and a 4-week low-nitrate (LO-NI, i.e., placebo) intervention in older adults with treated grade 1 hypertension, on the background of a low-nitrate diet and unaltered lifestyle.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna, Queensland University of Technology, Flinders University, Edith Cowan University
- Responsible party
- Principal investigator, Oliver Neubauer, University of Vienna
- Investigators
- Oliver Neubauer, Dr PhD, PD, Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584372
- Sponsor's protocol ID
- UVienna_Dietary nitrate
- Status last verified
- May 2023
- First submitted
- 29 Sep 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For long-time preservation and sharing of the research data, it is planned to use the PHAIDRA digital repository of the University of Vienna (https://phaidra.univie.ac.at). This repository enables the permanent secure storage of digital assists including open access publications and research data necessary to reproduce and to verify the results of the publications. For all publications and other data related to this research that will be made available, all of the individual participant data collected during the trial will be de-identified.
Publications
Raubenheimer K, Hickey D, Leveritt M, Fassett R, Ortiz de Zevallos Munoz J, Allen JD, Briskey D, Parker TJ, Kerr G, Peake JM, Pecheniuk NM, Neubauer O. Acute Effects of Nitrate-Rich Beetroot Juice on Blood Pressure, Hemostasis and Vascular Inflammation Markers in Healthy Older Adults: A Randomized, Placebo-Controlled Crossover Study. Nutrients. 2017 Nov 22;9(11):1270. doi: 10.3390/nu9111270.
PubMed 29165355Raubenheimer K, Bondonno C, Blekkenhorst L, Wagner KH, Peake JM, Neubauer O. Effects of dietary nitrate on inflammation and immune function, and implications for cardiovascular health. Nutr Rev. 2019 Aug 1;77(8):584-599. doi: 10.1093/nutrit/nuz025.
PubMed 31150091Blekkenhorst LC, Bondonno NP, Liu AH, Ward NC, Prince RL, Lewis JR, Devine A, Croft KD, Hodgson JM, Bondonno CP. Nitrate, the oral microbiome, and cardiovascular health: a systematic literature review of human and animal studies. Am J Clin Nutr. 2018 Apr 1;107(4):504-522. doi: 10.1093/ajcn/nqx046.
PubMed 29635489Fejes R, Seneca J, Pjevac P, Lutnik M, Weisshaar S, Pilat N, Steiner R, Wagner KH, Woodman RJ, Bondonno CP, Hodgson JM, Berry D, Wolzt M, Neubauer O. Increased Nitrate Intake From Beetroot Juice Over 4 Weeks Changes the Composition of the Oral, But Not the Intestinal Microbiome. Mol Nutr Food Res. 2025 Oct;69(20):e70156. doi: 10.1002/mnfr.70156. Epub 2025 Jun 16.
PubMed 40522148Fejes R, Pilat N, Lutnik M, Weisshaar S, Weijler AM, Kruger K, Draxler A, Bragagna L, Peake JM, Woodman RJ, Croft KD, Bondonno CP, Hodgson JM, Wagner KH, Wolzt M, Neubauer O. Effects of increased nitrate intake from beetroot juice on blood markers of oxidative stress and inflammation in older adults with hypertension. Free Radic Biol Med. 2024 Sep;222:519-530. doi: 10.1016/j.freeradbiomed.2024.07.004. Epub 2024 Jul 5.
PubMed 38972612Fejes R, Lutnik M, Weisshaar S, Pilat N, Wagner KH, Stuger HP, Peake JM, Woodman RJ, Croft KD, Bondonno CP, Hodgson JM, Wolzt M, Neubauer O. Increased nitrate intake from beetroot juice over 4 weeks affects nitrate metabolism, but not vascular function or blood pressure in older adults with hypertension. Food Funct. 2024 Apr 22;15(8):4065-4078. doi: 10.1039/d3fo03749e.
PubMed 38546454
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Nitrate on Vascular Function, Blood Pressure, the Oral Microbiome, and Biomarkers of Systemic Inflammation in Hypertensive Older Adults: a Randomized, Placebo-controlled Crossover Study
- ClinicalTrials.gov ID
- NCT04584372
- Acronym / sponsor ID
- UVienna_Dietary nitrate
- Conditions
- Hypertension, Inflammation
- Keywords
- dietary nitrate, inorganic nitrate-nitrite-nitric oxide pathway, oral microbiome, chronic low-grade inflammation, vascular integrity, high blood pressure, cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Collaborators
- Medical University of Vienna, Queensland University of Technology, Flinders University, Edith Cowan University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical research is funded by the Austrian Science Fund (FWF, project number: KLI 858). It is based on close collaborations between the University of Vienna and the Medical University of Vienna, with the Department of Clinical Pharmacology at the Medical University of Vienna as the clinical trial center and Prof. M.D. Michael Wolzt as the trial center's coordinating physician. The sponsor is the University of Vienna, as represented by the Principal Investigator Dr. Oliver Neubauer (Research Platform Active Ageing). International collaborations include Dr. Catherine Bondonno, Prof. Hodgson (both Edith Cowan University) Dr. Jonathan Peake (Queensland University of Technology), and Prof. Richard Woodman (Flinders University) (all Australia).
Wider research context / theoretical framework:
Aging is a major risk factor for cardiovascular disease (CVD). Developing effective strategies to improve cardiovascular health with ageing is a high priority. Emerging data indicate that inorganic dietary nitrate, found in green leafy vegetables and beetroot juice (BRJ), is important for cardiovascular health (Blekkenhorst et al. 2018). These data suggest that small increases in nitrate intake among those with elevated risk for CVD would have a substantial impact, by improving the bioavailability of nitric oxide (NO) through the enterosalivary nitrate- nitrite-NO pathway (involving the oral microbiome). Results from the study group's research suggest beneficial short-term effects of nitrate-rich BRJ on blood pressure and vascular inflammation markers in healthy older adults (Raubenheimer et al. 2017).
Hypotheses / research questions / objectives:
The proposed clinical study is aimed to examine whether the daily consumption of 2×70 mL BRJ over 4 weeks translates into improved clinical outcomes in older adults with treated grade 1 hypertension. The primary hypothesis is that the increased dietary nitrate intake lowers blood pressure and improves vascular function. The secondary hypotheses are that the increased dietary nitrate intake results in changes in the oral microbiome, favorably modulates the systemic inflammatory status, and that these changes correlate with cardiovascular-related outcomes.
Approach / methods:
This randomized, placebo-controlled crossover study will involve two 4-week treatment periods, consisting of interventions with nitrate-rich BRJ and nitrate-depleted BRJ, separated by a 4-week washout period. Thirty-five men and women, between the ages of 55 and 70 years, who have been diagnosed with grade 1 hypertension will be recruited. Twenty-nine participants will be required to complete the study, based on power/sample size calculations with the forearm blood flow (FBF) response to acetylcholine and 24 h-ambulatory systolic blood pressure as the primary endpoints. Principal secondary endpoints are the number of CD11b-expressing blood granulocytes and the FBF response to glyceryltrinitrate. Among various additional secondary and exploratory endpoints, plasma nitrate and nitrite and a broad range of inflammation biomarkers will be measured. Furthermore, the oral microbiome will be analyzed.
Level of originality / innovation:
Beneficial effects of nitrate have predominantly been observed in healthy populations, but evidence of cardiovascular benefits and anti-inflammatory effects in clinical populations is limited (Raubenheimer et al. 2019). This study addresses the need to determine the efficacy of dietary nitrate to improve cardiovascular health and counteract chronic low-grade inflammation in humans at risk of CVD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, mono-center, randomized, double-blind, placebo-controlled, crossover study The study will involve a randomized, placebo-controlled crossover design, with two 4-week treatment periods separated by a 4-week washout period. The two treatments will consist of a 4-week high-nitrate (HI-NI) and a 4-week low-nitrate (LO-NI, i.e., placebo) intervention in older adults with treated grade 1 hypertension, on the background of a low-nitrate diet and unaltered lifestyle.
| Arm | Type | Receives |
|---|---|---|
| High-nitrate (HI-NI) intervention | Active comparator | Dietary Supplement: High-nitrate interventionThe 'active treatment' arm will involve daily consumption of 2×70 mL nitrate-rich (HI-NI) beetroot juice (70 mL with breakfast and 70 mL with dinner) over an intervention period of 4 weeks. |
| Low-nitrate (LO-NI) intervention | Placebo comparator | Dietary Supplement: Low-nitrate interventionThe placebo treatment arm daily consumption of 2×70 mL nitrate-depleted (LO-NI) beetroot juice (70 mL with breakfast and 70 mL with dinner) an intervention period of 4 weeks. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulant male and females between 55 and 75 years of age, inclusive
- Resting systolic blood pressure between 130 and 170 mmHg, inclusive
- Written informed consent
Key exclusion criteria (17 listed)
- Diastolic blood pressure >110 mmHg
- Type 1 or 2 diabetes mellitus or fasting glucose >7.0 mmol/L
- Any evidence of acute or chronic disease such as symptomatic cardiovascular or peripheral vascular disease, moderate or severe chronic kidney disease (estimated glomerular filtration rate (GFR) <50 ml/min)), or cancer which is not in remission
- Consumption of ≥5 serves of vegetables per day
- Consumption of a diet estimated to contain >200 mg/d of nitrate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-nitrate interventionAlso: HI-NIThe 2×70 mL of nitrate-rich (i.e., 'high nitrate') beetroot juice contains 12.9 mmol nitrate (NO3-). | Dietary supplement | High-nitrate (HI-NI) intervention |
| Low-nitrate interventionAlso: LO-NIThe 2×70 mL of nitrate-depleted (i.e., 'low nitrate') beetroot juice contains 0.04 mmol (or less) nitrate. | Dietary supplement | Low-nitrate (LO-NI) intervention |
Primary outcome
Change in forearm blood flow (FBF) response to acetylcholine
Time frame: Change from baseline FBF at 4 weeks of the HI-NI intervention
Vascular function
Change in forearm blood flow (FBF) response to acetylcholine
Time frame: Change from baseline FBF at 4 weeks of the LO-NI intervention
Vascular function
Change in 24 hour-ambulatory systolic blood pressure
Time frame: Change from baseline 24 hour-ambulatory systolic blood pressure at 4 weeks of the HI-NI intervention
Blood pressure
Change in 24 hour-ambulatory systolic blood pressure
Time frame: Change from baseline 24 hour-ambulatory systolic blood pressure at 4 weeks of the LO-NI intervention
Blood pressure
4 secondary outcomes
Change in granulocyte CD11b expression
Time frame: Change from baseline granulocyte CD11b expression at 4 weeks of the HI-NI intervention
Change in granulocyte CD11b expression
Time frame: Change from baseline granulocyte CD11b expression at 4 weeks of the LO-NI intervention
Change in forearm blood flow (FBF) response to glyceryltrinitrate
Time frame: Change from baseline FBF at 4 weeks of the HI-NI intervention
Change in forearm blood flow (FBF) response to glyceryltrinitrate
Time frame: Change from baseline FBF at 4 weeks of the LO-NI intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 29165355Raubenheimer K, Hickey D, Leveritt M, Fassett R, Ortiz de Zevallos Munoz J, Allen JD, Briskey D, Parker TJ, Kerr G, Peake JM, Pecheniuk NM, Neubauer O. Acute Effects of Nitrate-Rich Beetroot Juice on Blood Pressure, Hemostasis and Vascular Inflammation Markers in Healthy Older Adults: A Randomized, Placebo-Controlled Crossover Study. Nutrients. 2017 Nov 22;9(11):1270. doi: 10.3390/nu9111270.
- Background: PubMed 31150091Raubenheimer K, Bondonno C, Blekkenhorst L, Wagner KH, Peake JM, Neubauer O. Effects of dietary nitrate on inflammation and immune function, and implications for cardiovascular health. Nutr Rev. 2019 Aug 1;77(8):584-599. doi: 10.1093/nutrit/nuz025.
- Background: PubMed 29635489Blekkenhorst LC, Bondonno NP, Liu AH, Ward NC, Prince RL, Lewis JR, Devine A, Croft KD, Hodgson JM, Bondonno CP. Nitrate, the oral microbiome, and cardiovascular health: a systematic literature review of human and animal studies. Am J Clin Nutr. 2018 Apr 1;107(4):504-522. doi: 10.1093/ajcn/nqx046.
- Derived from this study: PubMed 40522148Fejes R, Seneca J, Pjevac P, Lutnik M, Weisshaar S, Pilat N, Steiner R, Wagner KH, Woodman RJ, Bondonno CP, Hodgson JM, Berry D, Wolzt M, Neubauer O. Increased Nitrate Intake From Beetroot Juice Over 4 Weeks Changes the Composition of the Oral, But Not the Intestinal Microbiome. Mol Nutr Food Res. 2025 Oct;69(20):e70156. doi: 10.1002/mnfr.70156. Epub 2025 Jun 16.
- Derived from this study: PubMed 38972612Fejes R, Pilat N, Lutnik M, Weisshaar S, Weijler AM, Kruger K, Draxler A, Bragagna L, Peake JM, Woodman RJ, Croft KD, Bondonno CP, Hodgson JM, Wagner KH, Wolzt M, Neubauer O. Effects of increased nitrate intake from beetroot juice on blood markers of oxidative stress and inflammation in older adults with hypertension. Free Radic Biol Med. 2024 Sep;222:519-530. doi: 10.1016/j.freeradbiomed.2024.07.004. Epub 2024 Jul 5.
- Derived from this study: PubMed 38546454Fejes R, Lutnik M, Weisshaar S, Pilat N, Wagner KH, Stuger HP, Peake JM, Woodman RJ, Croft KD, Bondonno CP, Hodgson JM, Wolzt M, Neubauer O. Increased nitrate intake from beetroot juice over 4 weeks affects nitrate metabolism, but not vascular function or blood pressure in older adults with hypertension. Food Funct. 2024 Apr 22;15(8):4065-4078. doi: 10.1039/d3fo03749e.
- Individual participant dataSharing planned: Yes. For long-time preservation and sharing of the research data, it is planned to use the PHAIDRA digital repository of the University of Vienna (https://phaidra.univie.ac.at). This repository enables the permanent secure storage of digital assists including open access publications and research data necessary to reproduce and to verify the results of the publications. For all publications and other data related to this research that will be made available, all of the individual participant data collected during the trial will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Neubauer, Dr PhD, PD principal investigator
University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-nitrate intervention and Low-nitrate intervention in people with Hypertension and Inflammation, run by University of Vienna at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forearm blood flow (FBF) response to acetylcholine (time frame: Change from baseline FBF at 4 weeks of the HI-NI intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584372, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.