๐ฌIn plain words
What the trial is, and whether it could suit you
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 adaptat
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Postmenopausal women (amenorrhoeic โฅ1 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 Criteria:
* 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 VฬO2 max max above the 75th percentile of age- and sex-specific normative data: โฅ43 mL/kg/min for women aged 45-49 years, โฅ38 mL/kg/min for women aged 50-59 years, โฅ35 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 โฅ130/80 mm Hg
* Irregular resting electrocardiography (ECG)
* Inability to perform physical exercise
* Abnormal cardiovascular responses during the baseline V ฬO2 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
HealthTeky