HealthyWomen's-BeetNCT06527248
Nitrate, Exercise and Vascular Function in Midlife Women
A study testing Nitrate group in people with Healthy and Menopause, run by University of Vienna at 1 site in Austria.
Trial summary
The purpose of this clinical study in women after menopause is to investigate whether the daily intake of nitrate from beetroot juice over 12 weeks enhances the positive effect of exercise training on vascular function, blood pressure and physical performance. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Menopause, Hypertension
- What is being tested?
- Nitrate group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteAustria
- Study dates
- 31 Mar 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (amenorrhoeic ≥1 year), between the ages of 45 and 65 years, inclusive, who are either normotensive or are medically treated for stage 1 hypertension
- Written informed consent
Who cannot join
- Current or recent (within previous 3 months) engagement in exercise training (i.e., planned, structured, and regular exercise) with an average net exercise time of >2 hours per week
- Above-average cardiorespiratory fitness levels (i.e., a V̇O2 max max above the 75th percentile of age- and sex-specific normative data: ≥43 mL/kg/min for women aged 45-49 years, ≥38 mL/kg/min for women aged 50-59 years, ≥35 mL/kg/min for women aged 60-65 years)
- Any evidence of acute or chronic diseases such as symptomatic cardiovascular or peripheral vascular disease, moderate or severe chronic kidney disease (estimated glomerular filtration rate (GFR) <50 mL/min), pulmonary, neural, or musculoskeletal disease, osteoporotic fractures, cancer, or type 1 or 2 diabetes mellitus
- Fasting glucose >7.0 mmol/L or HbA1c > 6.5 rel. %
- BMI <18.5 kg/m2 or >30kg/m2
- A mean 24-hour ambulatory systolic/diastolic blood pressure of ≥130/80 mm Hg
Show all 19Show fewer
- Irregular resting electrocardiography (ECG)
- Inability to perform physical exercise
- Abnormal cardiovascular responses during the baseline V ̇O2 max test, including symptoms, ECG abnormalities, arrhythmias, or exaggerated blood pressure responses
- Current or recent (<12 months) oestrogen-based hormone-replacement therapy
- Chronic use of nitric oxide (NO) donors, organic nitrites/nitrates, Ticagrelor, sodium-glucose cotransporter 2 (SGLT2) inhibitors, high-dose statins (i.e., Simvastatin >40mg/day, Atorvastatin >20mg/day, Rosuvastatin >10mg/day), acetylsalicylic acid >100mg/day, non-steroidal anti-inflammatory drugs (NSAID)
- A change in drug therapy likely to influence major outcomes within the previous 2 months, or likelihood that drug therapy would change during the study
- Use of antibiotics (within previous 2 months)
- Use of antibacterial mouthwash (volunteers willing to cease using antibacterial mouthwash for a period of 4 weeks before randomization will be included)
- Being vegan or vegetarian or consumption of >5 serves of vegetables per day
- Current or recent (within previous 6 months) significant (>6%) loss or gain of body weight
- Current or recent (<12 months) regular smoking of >5 cigarettes per day
- Alcohol intake of >70 g per week and/or binge drinking behaviour
- Inability or unwillingness to follow the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
University of Vienna
Vienna, State of Vienna, 1090
Oliver Neubauer, Dr., Priv.-Doz. (PD), +43-1-4277-54933, oliver.neubauer@univie.ac.at
About this study
Official title: Effects of Dietary Nitrate From Beetroot Juice on Vascular Function and Adaptations to Exercise Training in Postmenopausal Women: a Randomized, Placebo-controlled Study
The purpose of this clinical study in women after menopause is to investigate whether the daily intake of nitrate from beetroot juice over 12 weeks enhances the positive effect of exercise training on vascular function, blood pressure and physical performance.
The risk of cardiovascular diseases (CVD) increases with advancing age and women are particularly affected. In women, the decline in the sex hormone oestrogen in the blood circulation with menopause contributes to impaired vascular function and an increased CVD risk; in part through increased inflammatory processes, oxidative stress, and a reduced body's own production of nitric oxide (NO). NO is a signaling molecule that is important for vascular function. Endurance-based exercise training is a key lifestyle strategy to prevent CVD. However, studies indicate that exercise is less effective in terms of its health-promoting adaptations in women after menopause as compared with men of similar age.
Read more
This study investigates the effect of exercise training in combination with the intake of nitrate-rich beetroot juice on functions of the cardiovascular system. Nitrate is a nitrogen compound that is found naturally in plant foods (e.g. beetroot juice) and is converted to NO in the human body. Results of previous studies indicate vasodilatory, blood pressure-lowering and performance-enhancing effects as well as positive influences on inflammatory processes and oxidative stress following nitrate intake. The hypothesis is that nitrate intake concomitant to training promotes training adaptations and further improves vascular function, blood pressure and physical performance compared to training without nitrate intake.
For the study, 54 untrained postmenopausal women (with the ages between 45 and 65 years) will be recruited and randomly allocated into two groups. Both groups will undergo 12 weeks of endurance-based exercise training. One group will receive nitrate-rich beetroot juice, and the other nitrate-depleted beetroot juice (as placebo). Vascular function, blood pressure, maximum oxygen uptake, and blood biomarkers for nitrate metabolism, inflammation status and oxidative stress will be examined.
The anticipated study results will provide new insights into whether nitrate as a 'training adjunct' improves health-promoting training adaptations in women after menopause. The overall aim is to improve the cardiovascular health and performance of middle-aged women and reduce their increased CVD risk.
Read the detailed description
Wider research context:
Advancing age is a major risk factor for cardiovascular diseases (CVD). In women, the decline in the sex hormone oestrogen with menopause contributes to impaired vascular function and an increased CVD risk, in part via a reduced bioavailability of the endothelium-derived signaling molecule nitric oxide (NO), chronic low-grade inflammation and increased oxidative stress. Aerobic (or endurance) exercise training is a key lifestyle strategy to prevent CVD. However, data indicate that exercise is less effective for improving cardiovascular health in postmenopausal women as compared with men of similar age. Oestrogen treatment may restore vascular training adaptations but is associated with health risks. The main objective of this research is to examine whether dietary nitrate as a nutritional 'adjuvant' to regular exercise could be an innovative lifestyle intervention to favorably modulate vascular training adaptations and health in midlife women. This research expands upon findings by the investigators and others showing that inorganic nitrate from vegetables exerts benefits on physical function and cardiovascular health by increasing NO availability through the nitrate-nitrite-NO pathway and by attenuating inflammation and oxidative stress.
Objectives and hypotheses:
The investigators propose a clinical study to examine whether the daily consumption of nitrate-rich beetroot juice concomitant with aerobic exercise training improves vascular function, blood pressure, and cardiovascular fitness in postmenopausal women more effectively as compared with nitrate-depleted beetroot juice consumption (as placebo). The hypothesis is that the increased nitrate intake favorably modulates the systemic inflammatory and oxidative stress status and promotes cardiovascular health-related training outcomes.
Methods:
This study will involve a prospective, randomized, placebo-controlled parallel-group design. 54 untrained postmenopausal women (45-65 years) will be recruited and randomized into two groups. Both groups will undergo 12 weeks of endurance-based exercise training. The training will consist of a supervised training program that meets contemporary guidelines on aerobic physical activity. One group will receive nitrate-rich beetroot juice (containing ~400 mg nitrate, based on available evidence on the physiological and ergogenic benefits of nitrate), and the other nitrate-depleted beetroot juice (placebo), on the background of a low-nitrate diet and an otherwise unaltered lifestyle. 42 participants (21 per group) will be required to complete the study, based on power/sample size calculations with the forearm blood flow response to acetylcholine as primary endpoint. Secondary endpoints and additional measures will include 24 h-ambulatory blood pressure, maximal oxygen uptake, and blood inflammation and oxidative stress biomarkers.
Originality and innovation:
It is anticipated that this work will provide important new evidence on the efficacy of dietary nitrate to improve the training responsiveness, vascular function, and cardiovascular health in women after menopause. The objective of such a combined nutritional-training approach is to promote, preserve or restore physiological function and delay or possibly prevent the transition to functional limitations and CVD.
Research funding and cooperation arrangements:
This clinical research is funded by the Austrian Science Fund (FWF) (grant DOI 10.55776/KLP1075624). It is based on close collaborations between the University of Vienna and the Medical University of Vienna (both Austria), 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 coordinating physician of the trial center. The sponsor is the University of Vienna, as represented by the Principal Investigator Dr. Oliver Neubauer, Priv.-Doz. (Department of Nutritional Sciences, University of Vienna). Further national collaborations involve the groups of Prof. M.D. Daniel König, Prof. Karl-Heinz Wagner (both University of Vienna), and Prof. Viktoria Weber (University for Continuing Education Krems, Austria). International collaborations include Dr. Catherine P. Bondonno, Prof. Jonathan M. Hodgson (both Edith Cowan University), Prof. Richard J. Woodman (Flinders University) (all Australia), Prof. Karsten Krüger (Justus Liebig University of Giessen, Germany), and Prof. Jason D. Allen (University of Virginia, USA).
- Conditions
- Healthy, Menopause, Hypertension, Inflammation
- Being tested
- Nitrate group, Placebo group
- Keywords
- Women after menopause, Vascular function, Exercise training responsiveness, Cardiovascular health, Dietary nitrate-nitrite-nitric oxide-pathway, Beetroot juice
- Medical subject headings
- Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate groupDietary supplement
Also called Nitrate-rich beetroot juice
Daily consumption of 70 mL beetroot juice containing ~400 mg nitrate over an intervention period of 12 weeks concomitant to exercise training, either 3 hours pre-exercise on training days or with breakfast on non-training days.
Placebo groupDietary supplement
Also called Nitrate-depleted beetroot juice
Daily consumption of 70 mL nitrate-depleted beetroot juice (placebo) over an intervention period of 12 weeks concomitant to exercise training, either 3 hours pre-exercise on training days or with breakfast on non-training days.
| Study group | Role | What they receive |
|---|---|---|
| Nitrate group | Active comparator | Daily consumption of 70 mL nitrate-rich beetroot juice concomitant with 12 weeks of exercise training Receives: Dietary Supplement: Nitrate group |
| Placebo group | Placebo comparator | Daily consumption of 70 mL nitrate-depleted beetroot juice (placebo) concomitant with 12 weeks of exercise training Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm blood flow (FBF) response to acetylcholine (FBFACh)
Endothelial-dependent microvascular function
Measured: Change from baseline FBFACh to after the 12-week intervention period
Secondary outcomes (2)
24-hour ambulatory systolic blood pressure
Ambulatory blood pressure monitoring
Measured: Change from baseline 24 hour-ambulatory systolic blood pressure to after the 12-week intervention period
Maximal oxygen uptake (V̇O2 max)
Cardiorespiratory fitness: V̇O2 max
Measured: Change from baseline V̇O2 max to after the 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start31 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, mono-center, randomized, double-blind, placebo-controlled, parellel-group study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna, Danube University Krems, University of Giessen, Edith Cowan University, Flinders University
- Responsible party
- Principal investigator, Oliver Neubauer, University of Vienna
- Investigators
- Oliver Neubauer, Dr.Priv.Doz., Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527248
- Sponsor's protocol ID
- UVienna_Women's-Beet
- Acronym
- Women's-Beet
- Status last verified
- May 2026
- First submitted
- 24 Jul 2024
- Last updated
- 5 Jun 2026
- 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, 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 31150091Woessner MN, McIlvenna LC, Ortiz de Zevallos J, Neil CJ, Allen JD. Dietary nitrate supplementation in cardiovascular health: an ergogenic aid or exercise therapeutic? Am J Physiol Heart Circ Physiol. 2018 Feb 1;314(2):H195-H212. doi: 10.1152/ajpheart.00414.2017. Epub 2017 Nov 3.
PubMed 29101174Shannon OM, Allen JD, Bescos R, Burke L, Clifford T, Easton C, Gonzalez JT, Jones AM, Jonvik KL, Larsen FJ, Peeling P, Piknova B, Siervo M, Vanhatalo A, McGawley K, Porcelli S. Dietary Inorganic Nitrate as an Ergogenic Aid: An Expert Consensus Derived via the Modified Delphi Technique. Sports Med. 2022 Oct;52(10):2537-2558. doi: 10.1007/s40279-022-01701-3. Epub 2022 May 23.
PubMed 35604567Moreau KL, Clayton ZS, DuBose LE, Rosenberry R, Seals DR. Effects of regular exercise on vascular function with aging: Does sex matter? Am J Physiol Heart Circ Physiol. 2024 Jan 1;326(1):H123-H137. doi: 10.1152/ajpheart.00392.2023. Epub 2023 Nov 3.
PubMed 37921669Baranauskas MN, Freemas JA, Tan R, Carter SJ. Moving beyond inclusion: Methodological considerations for the menstrual cycle and menopause in research evaluating effects of dietary nitrate on vascular function. Nitric Oxide. 2022 Jan 1;118:39-48. doi: 10.1016/j.niox.2021.11.001. Epub 2021 Nov 11.
PubMed 34774755Hogwood AC, Ortiz de Zevallos J, Weeldreyer N, Clark JR, Mazzella V, Cain L, Myaing D, Love KM, Weltman A, Allen JD. The acute effects of exercise intensity and inorganic nitrate supplementation on vascular health in females after menopause. J Appl Physiol (1985). 2023 Nov 1;135(5):1070-1081. doi: 10.1152/japplphysiol.00559.2023. Epub 2023 Oct 5.
PubMed 37795531Fejes 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 38972612
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Nitrate From Beetroot Juice on Vascular Function and Adaptations to Exercise Training in Postmenopausal Women: a Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06527248
- Acronym / sponsor ID
- Women's-Beet / UVienna_Women's-Beet
- Conditions
- Healthy, Menopause, Hypertension, Inflammation
- Keywords
- Women after menopause, Vascular function, Exercise training responsiveness, Cardiovascular health, Dietary nitrate-nitrite-nitric oxide-pathway, Beetroot juice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Collaborators
- Medical University of Vienna, Danube University Krems, University of Giessen, Edith Cowan University, Flinders University
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Jul 2024 (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 purpose of this clinical study in women after menopause is to investigate whether the daily intake of nitrate from beetroot juice over 12 weeks enhances the positive effect of exercise training on vascular function, blood pressure and physical performance.
The risk of cardiovascular diseases (CVD) increases with advancing age and women are particularly affected. In women, the decline in the sex hormone oestrogen in the blood circulation with menopause contributes to impaired vascular function and an increased CVD risk; in part through increased inflammatory processes, oxidative stress, and a reduced body's own production of nitric oxide (NO). NO is a signaling molecule that is important for vascular function. Endurance-based exercise training is a key lifestyle strategy to prevent CVD. However, studies indicate that exercise is less effective in terms of its health-promoting adaptations in women after menopause as compared with men of similar age.
This study investigates the effect of exercise training in combination with the intake of nitrate-rich beetroot juice on functions of the cardiovascular system. Nitrate is a nitrogen compound that is found naturally in plant foods (e.g. beetroot juice) and is converted to NO in the human body. Results of previous studies indicate vasodilatory, blood pressure-lowering and performance-enhancing effects as well as positive influences on inflammatory processes and oxidative stress following nitrate intake. The hypothesis is that nitrate intake concomitant to training promotes training adaptations and further improves vascular function, blood pressure and physical performance compared to training without nitrate intake.
For the study, 54 untrained postmenopausal women (with the ages between 45 and 65 years) will be recruited and randomly allocated into two groups. Both groups will undergo 12 weeks of endurance-based exercise training. One group will receive nitrate-rich beetroot juice, and the other nitrate-depleted beetroot juice (as placebo). Vascular function, blood pressure, maximum oxygen uptake, and blood biomarkers for nitrate metabolism, inflammation status and oxidative stress will be examined.
The anticipated study results will provide new insights into whether nitrate as a 'training adjunct' improves health-promoting training adaptations in women after menopause. The overall aim is to improve the cardiovascular health and performance of middle-aged women and reduce their increased CVD risk.
Detailed description
Wider research context:
Advancing age is a major risk factor for cardiovascular diseases (CVD). In women, the decline in the sex hormone oestrogen with menopause contributes to impaired vascular function and an increased CVD risk, in part via a reduced bioavailability of the endothelium-derived signaling molecule nitric oxide (NO), chronic low-grade inflammation and increased oxidative stress. Aerobic (or endurance) exercise training is a key lifestyle strategy to prevent CVD. However, data indicate that exercise is less effective for improving cardiovascular health in postmenopausal women as compared with men of similar age. Oestrogen treatment may restore vascular training adaptations but is associated with health risks. The main objective of this research is to examine whether dietary nitrate as a nutritional 'adjuvant' to regular exercise could be an innovative lifestyle intervention to favorably modulate vascular training adaptations and health in midlife women. This research expands upon findings by the investigators and others showing that inorganic nitrate from vegetables exerts benefits on physical function and cardiovascular health by increasing NO availability through the nitrate-nitrite-NO pathway and by attenuating inflammation and oxidative stress.
Objectives and hypotheses:
The investigators propose a clinical study to examine whether the daily consumption of nitrate-rich beetroot juice concomitant with aerobic exercise training improves vascular function, blood pressure, and cardiovascular fitness in postmenopausal women more effectively as compared with nitrate-depleted beetroot juice consumption (as placebo). The hypothesis is that the increased nitrate intake favorably modulates the systemic inflammatory and oxidative stress status and promotes cardiovascular health-related training outcomes.
Methods:
This study will involve a prospective, randomized, placebo-controlled parallel-group design. 54 untrained postmenopausal women (45-65 years) will be recruited and randomized into two groups. Both groups will undergo 12 weeks of endurance-based exercise training. The training will consist of a supervised training program that meets contemporary guidelines on aerobic physical activity. One group will receive nitrate-rich beetroot juice (containing ~400 mg nitrate, based on available evidence on the physiological and ergogenic benefits of nitrate), and the other nitrate-depleted beetroot juice (placebo), on the background of a low-nitrate diet and an otherwise unaltered lifestyle. 42 participants (21 per group) will be required to complete the study, based on power/sample size calculations with the forearm blood flow response to acetylcholine as primary endpoint. Secondary endpoints and additional measures will include 24 h-ambulatory blood pressure, maximal oxygen uptake, and blood inflammation and oxidative stress biomarkers.
Originality and innovation:
It is anticipated that this work will provide important new evidence on the efficacy of dietary nitrate to improve the training responsiveness, vascular function, and cardiovascular health in women after menopause. The objective of such a combined nutritional-training approach is to promote, preserve or restore physiological function and delay or possibly prevent the transition to functional limitations and CVD.
Research funding and cooperation arrangements:
This clinical research is funded by the Austrian Science Fund (FWF) (grant DOI 10.55776/KLP1075624). It is based on close collaborations between the University of Vienna and the Medical University of Vienna (both Austria), 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 coordinating physician of the trial center. The sponsor is the University of Vienna, as represented by the Principal Investigator Dr. Oliver Neubauer, Priv.-Doz. (Department of Nutritional Sciences, University of Vienna). Further national collaborations involve the groups of Prof. M.D. Daniel König, Prof. Karl-Heinz Wagner (both University of Vienna), and Prof. Viktoria Weber (University for Continuing Education Krems, Austria). International collaborations include Dr. Catherine P. Bondonno, Prof. Jonathan M. Hodgson (both Edith Cowan University), Prof. Richard J. Woodman (Flinders University) (all Australia), Prof. Karsten Krüger (Justus Liebig University of Giessen, Germany), and Prof. Jason D. Allen (University of Virginia, USA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, mono-center, randomized, double-blind, placebo-controlled, parellel-group study
| Arm | Type | Receives |
|---|---|---|
| Nitrate group | Active comparator | Dietary Supplement: Nitrate groupDaily consumption of 70 mL nitrate-rich beetroot juice concomitant with 12 weeks of exercise training |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupDaily consumption of 70 mL nitrate-depleted beetroot juice (placebo) concomitant with 12 weeks of exercise training |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women (amenorrhoeic ≥1 year), between the ages of 45 and 65 years, inclusive, who are either normotensive or are medically treated for stage 1 hypertension
- Written informed consent
Key exclusion criteria (19 listed)
- Current or recent (within previous 3 months) engagement in exercise training (i.e., planned, structured, and regular exercise) with an average net exercise time of >2 hours per week
- Above-average cardiorespiratory fitness levels (i.e., a V̇O2 max max above the 75th percentile of age- and sex-specific normative data: ≥43 mL/kg/min for women aged 45-49 years, ≥38 mL/kg/min for women aged 50-59 years, ≥35 mL/kg/min for women aged 60-65 years)
- Any evidence of acute or chronic diseases such as symptomatic cardiovascular or peripheral vascular disease, moderate or severe chronic kidney disease (estimated glomerular filtration rate (GFR) <50 mL/min), pulmonary, neural, or musculoskeletal disease, osteoporotic fractures, cancer, or type 1 or 2 diabetes mellitus
- Fasting glucose >7.0 mmol/L or HbA1c > 6.5 rel. %
- BMI <18.5 kg/m2 or >30kg/m2
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 |
|---|---|---|
| Nitrate groupAlso: Nitrate-rich beetroot juiceDaily consumption of 70 mL beetroot juice containing ~400 mg nitrate over an intervention period of 12 weeks concomitant to exercise training, either 3 hours pre-exercise on training days or with breakfast on non-training days. | Dietary supplement | Nitrate group |
| Placebo groupAlso: Nitrate-depleted beetroot juiceDaily consumption of 70 mL nitrate-depleted beetroot juice (placebo) over an intervention period of 12 weeks concomitant to exercise training, either 3 hours pre-exercise on training days or with breakfast on non-training days. | Dietary supplement | Placebo group |
Primary outcome
Forearm blood flow (FBF) response to acetylcholine (FBFACh)
Time frame: Change from baseline FBFACh to after the 12-week intervention period
Endothelial-dependent microvascular function
2 secondary outcomes
24-hour ambulatory systolic blood pressure
Time frame: Change from baseline 24 hour-ambulatory systolic blood pressure to after the 12-week intervention period
Maximal oxygen uptake (V̇O2 max)
Time frame: Change from baseline V̇O2 max to after the 12-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- 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 29101174Woessner MN, McIlvenna LC, Ortiz de Zevallos J, Neil CJ, Allen JD. Dietary nitrate supplementation in cardiovascular health: an ergogenic aid or exercise therapeutic? Am J Physiol Heart Circ Physiol. 2018 Feb 1;314(2):H195-H212. doi: 10.1152/ajpheart.00414.2017. Epub 2017 Nov 3.
- Background: PubMed 35604567Shannon OM, Allen JD, Bescos R, Burke L, Clifford T, Easton C, Gonzalez JT, Jones AM, Jonvik KL, Larsen FJ, Peeling P, Piknova B, Siervo M, Vanhatalo A, McGawley K, Porcelli S. Dietary Inorganic Nitrate as an Ergogenic Aid: An Expert Consensus Derived via the Modified Delphi Technique. Sports Med. 2022 Oct;52(10):2537-2558. doi: 10.1007/s40279-022-01701-3. Epub 2022 May 23.
- Background: PubMed 37921669Moreau KL, Clayton ZS, DuBose LE, Rosenberry R, Seals DR. Effects of regular exercise on vascular function with aging: Does sex matter? Am J Physiol Heart Circ Physiol. 2024 Jan 1;326(1):H123-H137. doi: 10.1152/ajpheart.00392.2023. Epub 2023 Nov 3.
- Background: PubMed 34774755Baranauskas MN, Freemas JA, Tan R, Carter SJ. Moving beyond inclusion: Methodological considerations for the menstrual cycle and menopause in research evaluating effects of dietary nitrate on vascular function. Nitric Oxide. 2022 Jan 1;118:39-48. doi: 10.1016/j.niox.2021.11.001. Epub 2021 Nov 11.
- Background: PubMed 37795531Hogwood AC, Ortiz de Zevallos J, Weeldreyer N, Clark JR, Mazzella V, Cain L, Myaing D, Love KM, Weltman A, Allen JD. The acute effects of exercise intensity and inorganic nitrate supplementation on vascular health in females after menopause. J Appl Physiol (1985). 2023 Nov 1;135(5):1070-1081. doi: 10.1152/japplphysiol.00559.2023. Epub 2023 Oct 5.
- Background: 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.
- 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.
Oliver Neubauer, Dr.Priv.Doz. principal investigator
University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate group in people with Healthy and Menopause, run by University of Vienna at 1 site 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 2 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliver Neubauer, Dr.Priv.Doz. (+4314277 ext. 54933, oliver.neubauer@univie.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm blood flow (FBF) response to acetylcholine (FBFACh) (time frame: Change from baseline FBFACh to after the 12-week intervention period). 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 NCT06527248, which also lists 7 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 5 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.