Nitrate and Exercise for vascular health in midlife women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will compare a nitrate-rich beetroot juice group with a placebo group, both undergoing an aerobic exercise program, to see if dietary nitrate enhances vascular function and physical performance. Participants are postmenopausal women aged 45–65, with or without treated stage 1 hypertension. The trial uses the nitrate-nitrite-NO pathway to potentially boost the vascular adaptations to exercise and reduce inflammation and oxidative stress. It aims to determine if the combination provides greater benefits than exercise alone. The study is led by the University of Vienna with collaborators in Vienna and Giessen.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Vienna
  Vienna, State of Vienna, Austria Recruiting

Study contacts

• Principal investigator: Oliver Neubauer, Dr.Priv.Doz. — University of Vienna
• Study coordinator: Oliver Neubauer, Dr.Priv.Doz.
• Email: oliver.neubauer@univie.ac.at
• Phone: +4314277

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using low-dose aspirin after preeclampsia to improve recovery

  This study is testing if taking low-dose aspirin for six months after having preeclampsia can help new moms recover better by improving their blood pressure and blood vessel function.

  Recruiting Phase 4 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT06281665

• Impact of early menopause on blood pressure regulation in women

  This study is trying to see how early menopause affects blood pressure control in women aged 35 to 70 by comparing those who went through menopause early with those who haven’t.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT04439370

• Hop extract vs soy isoflavone for menopausal symptoms

  This study tests whether a full-spectrum hop extract helps reduce menopausal mood symptoms better than soy isoflavones in peri- and postmenopausal women.

  Recruiting Menoclinica by Palacios · Madrid, Madrid · NCT07904390

• IMB-guided health education to boost medication taking and blood pressure control in adults with hypertension

  This study tests a health-literacy program based on Information-Motivation-Behavioral Skills to help adults with hypertension who don’t take their medicines regularly to take them more consistently and better control their blood pressure.

  Recruiting at 8 sites Bahir Dar University · Ādēt and 7 other locations · NCT07894068

• Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF

  This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT07893821

• Hypertension: Does Education Help Patients Manage Blood Pressure Better?

  This study tests whether structured patient education improves blood pressure control and self-management in adults with hypertension who speak Turkish.

  Recruiting Inonu University · Batman, Center · NCT07890090

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.