Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT07242066
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Participant is willing and able to comply with the requirements of the study protocol.
* Non-smoking men and women.
* Aged between 50-75 years.
* Overweight and obese (BMI: over 25.0 kg/m2).
Exclusion Criteria:
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.
* Vegetarian.
* Smoking.
* Resting systolic blood pressure greater than 160 mmHg; diastolic blood pressure greater than 100 mmHg.
* Active cancer and any diagnosis of malignant cancer in the last 5 years.
* Excessive alcohol intake (\>21 units per week).
* Allergy or intolerance to the intervention food (Beetroot juice).
* Diagnosis of chronic or acute metabolic and inflammatory conditions that may interfere with the study outcomes.
* Major surgical operations.
* Use of prescribed psychiatric drugs (antidepressants, sedatives, antipsychotics), diuretics, organic nitrates, statins and proton pump inhibitors.
* Use of prescribed hormonal therapies (oestrogens, thyroxin, and progesterone), anti-hypertensive (Calcium++ channel blockers, beta-blockers, and angiotensin-converting-enzyme (ACE) inhibitors), only if the prescription had started, or the dose had been started/changed, in the previous three months.
* Non-prescribed dietary supplements if not stopped at least for 2 weeks before starting the trial.
* Use of the mouthwash during the study was not allowed as it interferes with the conversion of oral nitrate into nitrite.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT07242066
Study Brief:
Protocol Section:
NCT07242066