Status:
NOT_YET_RECRUITING
Nitrate, Exercise and Vascular Function in Midlife Women
Lead Sponsor:
University of Vienna
Collaborating Sponsors:
Medical University of Vienna
Danube University Krems
Conditions:
Healthy
Menopause
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief 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...
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 func...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06527248
Start Date
January 1 2025
End Date
March 1 2027
Last Update
August 9 2024
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