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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05414851
Eligibility Criteria:
Inclusion Criteria:
* Age \>50
* Diagnosis of any of the following cardiovascular risk factors: hypertension (Diagnosis present in chart or use of antihypertensive medications); hyperlipidemia/dyslipidemia (non-HDL cholesterol ≥ 130 within the past year or current use of antihyperlipidemic medication); prediabetes (HbA1c ≥ 5.7% and \< 6.5% in the past year); diabetes (HbA1c ≥ 6.5% in the past year); obesity (body mass index ≥ 30).
* Willing and able to comply with the protocol for the duration of the study, including food provision, scheduled meetings and testing visits.
* Able to speak and read English fluently because counseling and education is only available in English.
Exclusion Criteria:
* Active malabsorption syndrome (celiac disease, history of gastric bypass within the past year, uncontrolled Crohn's disease, protein-losing enteropathy, etc…)
* Use of any of the following medications that require close monitoring and adjustment during major dietary change: insulin, sulfonylureas, or warfarin
* Chronic or acute kidney disease, with eGFR \< 50 on two or more lab tests in the past 6 months
* Diagnosis of cirrhosis or liver failure
* Hyperkalemia (defined as potassium \>5.4 on two or more lab tests in the past 6 months)
* Major surgery in the past 3 months
* Myocardial infarction in the past 6 months
* Current, active eating disorder as determined by chart review, investigator assessment, or subject history
* Food allergies or intolerances that would interfere with eating study food or require special accommodation as determined by subject history, investigator assessment, or chart review
* Consuming a current diet described by the subject as vegetarian, vegan, very low-carbohydrate, or ketogenic
* Illicit drug use (not including marijuana)
* High risk alcohol use, based on subject history (defined as greater than 7 drinks/week for women and greater than 14 drinks/week for men)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05414851
Study Brief:
Protocol Section:
NCT05414851