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 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT05628350
Eligibility Criteria:
Inclusion Criteria:
* Weight stable for previous 6 months (\<2 kg change)
* Sedentary to recreationally active
* No plans to gain/lose weight or change physical activity level
* Willing to pick up food daily and consume foods provided for an 8-week period
* Verbal and written informed consent
* Approval by Medical Director
* Usual UPF intake +/-15% of US average of 60% total energy
* Estrogen or testosterone usage is acceptable, if on stable dose for \>6 months
* Lipid-lowering medication usage is acceptable, if on a stable dose for \>6 months
Exclusion Criteria:
* BMI \>35 kg/m2
* Diabetes or diabetes medication
* Antibiotic, prebiotic or prebiotic use in prior 3 months
* Total Cholesterol \>6.2 mmol/L; Triglycerides \>4.5 mmol/L
* Blood pressure (BP) \> 159/99 mmHg (Stable BP on antihypertensive medications is acceptable)
* Diagnosed inflammatory bowel disease
* Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
* Vegetarian or vegan
* Pregnant or plans to become pregnant
* Food allergies or aversions
* 3 or fewer stools per week or regular laxative use
* Lipid-lowering medication usage \<6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT05628350
Study Brief:
Protocol Section:
NCT05628350