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Official title Nitrate, Exercise and Vascular Function in Midlife Women
ClinicalTrials.gov ID: NCT06527248
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- Postmenopausal women (amenorrhoeic ≥1 year), between the ages of 45 and 65 years, inclusive, who are either normotensive or are medically treated for...
- Written informed consent
You likely can't join if
- Current or recent (within previous 3 months) engagement in exercise training (i.e., planned, structured, and regular exercise) with an average net...
- 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...
- Any evidence of acute or chronic diseases such as symptomatic cardiovascular or peripheral vascular disease, moderate or severe chronic kidney...
- Fasting glucose \>7.0 mmol/L or HbA1c \> 6.5 rel. %
- BMI \ 30kg/m2
- A mean 24-hour ambulatory systolic/diastolic blood pressure of ≥130/80 mm Hg
See the full eligibility criteria
- 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
- 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...
- 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...
- Fasting glucose \>7.0 mmol/L or HbA1c \> 6.5 rel. %
- BMI \ 30kg/m2
- A mean 24-hour ambulatory systolic/diastolic blood pressure of ≥130/80 mm Hg
- 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...
- 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 (\ 5 cigarettes per day
- Alcohol intake of \>70 g per week and/or binge drinking behaviour
- Inability or unwillingness to follow the study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, State of Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 45 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, State of Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.