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:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT04530916
Eligibility Criteria:
Inclusion Criteria:
* Men and postmenopausal women
* Aged 45-70 years
* Elevated blood pressure or stage 1-Hypertension
* Ability to provide informed consent
Exclusion Criteria:
* Have had a menstrual cycle within the past year
* Blood Pressure \< 120 (systolic BP) or ≥ 140/90 mm Hg
* Reactive hyperemia index \> 3.00%
* Taking \> 1 antihypertensive medication, taking 1 antihypertensive medication more than 1 time per day, and/or taking the antihypertensive medication for \< 3 months
* Diagnosed cancer, cardiovascular disease, diabetes, or gastrointestinal, kidney, liver, lung, and/or pancreatic disease
* Triglycerides \> 350 mg/dL, low-density lipoprotein cholesterol (LDL-C) ≥ 190 mg/dL, hemoglobin A1c ≥ 6.5%, and/or taking a lipid-lowering or glucose-lowering medication
* Testosterone or estrogen replacement therapy use 6 months prior to study start
* Weight change ≥ 3 kg in the past 3 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study
* Current smokers or history of smoking in the past 12 months
* Binge and/or heavy drinker (\>3 drinks on any given occasion and/or \>7 drinks/week for women, and \>4 drinks on any given occasion and/or \>14 drinks/week for men)
* Body mass index \< 18.5 or \> 40 kg/m2
* Antibiotic therapy within past two months
* Allergies or contraindication to study treatments or procedures
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT04530916
Study Brief:
Protocol Section:
NCT04530916