Nitrate, Exercise and Vascular Function in Midlife Women

Launched by UNIVERSITY OF VIENNA · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how daily intake of nitrate from beetroot juice, combined with exercise, affects heart health in postmenopausal women. The goal is to see if drinking beetroot juice can help improve blood vessel function, lower blood pressure, and boost physical performance during a 12-week exercise program. As women age and go through menopause, they often experience changes that can increase their risk of heart diseases, so this study aims to find new ways to support their cardiovascular health.

To participate in this trial, women aged 45 to 65 who have been postmenopausal for at least a year and are either healthy or mildly hypertensive (high blood pressure) may be eligible. Participants will be divided into two groups: one will drink nitrate-rich beetroot juice, while the other will receive a placebo (a version without the active ingredient). Both groups will follow the same exercise program. Throughout the study, researchers will monitor various health markers, including blood pressure and how well the heart and blood vessels are functioning. This research hopes to provide valuable insights into how dietary nitrate can enhance the benefits of exercise for middle-aged women and help reduce their risk of heart-related issues.

Gender

FEMALE

Eligibility criteria

• Inclusion 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
• 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 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