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 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT05296395
Eligibility Criteria:
Inclusion Criteria:
* Ages 50-99 years
* For women: 12 months or more since last menstruation
Exclusion Criteria:
* Systolic Blood Pressure ≥ 130 mmHg or Diastolic BP ≥ 80mmHg
* Currently taking pharmacological therapies for hypertension, dyslipidemia, or glucose control
* Diabetes (type 1 or 2) or glycosylated hemoglobin ≥ 5/7%
* LDL Cholesterol \> 160 mg/dL or Total Cholesterol \> 200 mg/dL
* Cigarette use within 3 years of enrollment
* Average of \> 7500 steps per day as measured during screening period
* Received probiotics, prebiotics, and/or antibiotics within six weeks of enrollment
* History of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within 3 years of enrollment
* History of inflammatory rheumatic diseases known to increase atherosclerotic cardiovascular risk (e.g. rheumatoid arthritis, systemic lupus erythematosus)
* Known history of cognitive impairment or inability to follow study procedures
* GI tract illnesses such as short gut syndrome, inflammatory bowel disease, or an ileostomy
* Daily alcohol use
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
99 Years
Study:
NCT05296395
Study Brief:
Protocol Section:
NCT05296395