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:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04398693
Eligibility Criteria:
Inclusion Criteria:
* Be normotensive, controlled hypertensive or resistant hypertensive.
* Body Mass Index (BMI) \< 35 kg/m 2 .
* If diabetic, glycated hemoglobin must be ≤ 9.0%.
* Agree and sign the Free Informed Consent Form (FICF).
Exclusion Criteria:
* BMI ≥ 35 kg/m 2 ;
* Urinary Sodium ≥ 200mEq/L in 24-hour urine;
* Bariatric Surgery;
* Recent use of antibiotics or probiotics (\<3 months);
* Prior Cardiovascular Disease: Acute Myocardial Infarction, Stroke, Heart Failure, Angina Pectoris, Peripheral Arterial Insufficiency;
* Chronic kidney disease (glomerular filtration rate (GFR) \< 30 mL/min/m 2 );
* Chronic Disease limiting participation at the study or life expectancy (e.g.: cancer, among others);
* Gastrointestinal diseases (including inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other disabsortive disease)
* Pregnant or having the intension of become pregnant in the next two years;
* Participation in any other clinical studies in the past six months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT04398693
Study Brief:
Protocol Section:
NCT04398693