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 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT06286761
Eligibility Criteria:
Inclusion Criteria:
* ≥18 and ≤75 years of age
* body mass index ≥18.5 and ≤45 kg/m2
* Weight stable (i.e., ≤3% change)
* ≤150 min of structured exercise/week for at least 2 months before entering the study
* Blood glucose: \< 126 mg/dl fasted, \< 200 mg/dl with 2 hour oral glucose tolerance testing
* Hemoglobin A1C (HbA1C) ≤6.5%
* Dyslipidemia triglycerides ≥125 mg/dL
* No chronic kidney disease
* Not vegan or vegetarian or on high protein diet (e.g. Atkins) or supplements that are not allowed
* No intolerance or allergies to study diet ingredients
* No excessive alcohol or tobacco consumption
Exclusion Criteria:
* \<18 and \>75 years of age
* body mass index \<18.5 or \>45 kg/m2
* history of or current significant organ system dysfunction (e.g., heart disease, stroke, diabetes, cancer in remission for \<5 years, dementia, chronic kidney disease)
* allergies or intolerances to meal ingredients, vegans or vegetarians
* use of medications that could confound the study outcomes (e.g., anti-inflammatories, immune modulators, etc)
* take dietary supplements (e.g., certain pre- and pro-biotics, fiber, fish oil supplements)
* engaged in regular structured exercise \>150 min per week
* alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances
* pregnant women
* persons who use tobacco
* prisoners
* the inability to grant voluntary informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06286761
Study Brief:
Protocol Section:
NCT06286761