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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT06025357
Eligibility Criteria:
Inclusion Criteria:
Must present at least 3 of the following 5 cardiometabolic risk factors
* Waist circumference ≥88 cm
* Fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%.
* Blood pressure ≥130 mm Hg
* Triglyceride ≥ 150 mg/dL
* HDL \<50 mg/dL
The following are also inclusion criteria's:
* Women aged 45-79 years old
* Body mass index ≤ 39.9 kg/m2
* Sedentary (defined as \< 120 min/week of exercise)
* Abstain from any dietary supplements with vascular effects for one month prior to the beginning of the study and until participation in study has terminated.
Exclusion Criteria:
* \< 45 and \> 79 years of age
* Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, biguanides, insulin, beta blockers, statins, verapamil)
* Systolic blood pressure ≥ 160 mmHg
* BMI \> 40 kg/m2
* Recent changes in medication (3 months)
* Current smoking any tobacco use
* Cardiovascular disease, diabetes (Type 1 or 2), and other metabolic or chronic diseases
* More than 7 alcoholic drinks/week of consumption
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
79 Years
Study:
NCT06025357
Study Brief:
Protocol Section:
NCT06025357