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 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT07206303
Eligibility Criteria:
Inclusion Criteria:
* Men or women, aged 40-65 years old.
* Chinese residing in Hong Kong.
* Clinic SBP ≥130mmHg according to screening measurement at baseline.
* Untreated or not on antihypertensive medications within 4 weeks.
* Able to provide informed consent.
Exclusion Criteria:
* Clinic SBP \>165mmHg according to screening measurement at baseline
* Known history of diabetes, coronary artery disease, stroke, peripheral artery disease, malignancy or chronic kidney disease
* Known history of gastrointestinal disorders including inflammatory bowel disease, irritable bowel syndrome, Helicobacter pylori infection, liver cirrhosis or long-term use of proton pump inhibitors.
* Known increased risk of infection due to endovascular or rheumatic heart disease, endovascular grafts, congenital heart defects, endocarditis, mechanical heart valves, and permanent endovascular devices including permanent (not temporary) hemodialysis catheters, pacemakers, or defibrillators.
* Known secondary causes of hypertension.
* Currently taking omega-3 fatty acid supplements, probiotics, antibiotics, rifaximin, steroids, and antihypertensive agents within 4 weeks.
* Currently taking anti-oxidant vitamins within 6 months.
* Recent travel to tropical areas within 6 months.
* Recent bariatric surgery, hepatic resection, intestinal resection/colectomy, or any surgery within 3 months before the study.
* Identified higher susceptibility to infections caused by immunosuppression, such as a history of organ or hematopoietic stem cell (HSCs) transplant, neutropenia (ANC \<500 cells/µl), HIV, and CD4 \<200 cells/µl.
* Known allergies to any components of commercially-available probiotic supplements.
* Women who are pregnant, or intending to become pregnant, or lactation.
* Intending to participate or have participated in a clinical or nutritional intervention study in the last 30 days before study enrolment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT07206303
Study Brief:
Protocol Section:
NCT07206303