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:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT05782218
Eligibility Criteria:
Inclusion Criteria:
* Men and women
* 18 to 50 years of age
* Body mass index (BMI) categorized "normal" through "overweight" (18.5 - 29.9 kg/m2)
* Able to provide informed consent in English
Exclusion Criteria:
* pregnancy or lactation
* allergy or aversion to any of the foods that will be studied and/or provided
* history of gastrointestinal disorders including ulcerative colitis, Crohn's disease, celiac sprue, hereditary non-polyposis colorectal cancer (HNPCC), familial adenomatous polyposis, pancreatic disease, or liver disease
* history of metabolic diseases (type 2 diabetes, hyperlipidemia)
* previous gastrointestinal resection or bariatric surgery
* bleeding disorders that preclude blood draws
* recent hospital admissions (past 6 months) for heart disease (MI/CVA or CHF) or other CVD/CAD conditions under physician guided therapy that is not medically stable
* cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment
* regular alcohol intake of \> 2 drinks/day (equivalent to 720 mL of beer, 240 mL of wine, or 90 mL of spirits) and unwilling to abstain during the run-in week and test day
* use of tobacco and/or marijuana, hookahs, e-cigarettes (e-cigs, vapes, etc.) and not willing to abstain during the run-in week and test day
* use of illicit drugs and not willing to abstain during the run-in week and test day
* BMI ≥30 kg/m2
* regular (daily to weekly) use of over the counter (OTC) weight-loss aids, anti-acids or anti-inflammatories, and unwilling or unable to stop taking during the run-in week and test day
* regular OTC dietary supplements that interfere with the test foods being studied including pills, chewables, liquids or powders for the following: fiber, fish oil (including cod liver oil), probiotics, and unwilling or unable to stop taking during the run-in week and test day
* oral or IV antibiotic use in the past 6 months (could defer participation until 6 months post-completion of course of antibiotics)
* seated blood pressure \>140/90 mmHg
* fasting clinical lab tests outside acceptable values as ascertained at the screening blood draw (Glucose (fasting), Urea, Creatinine, eGFR, Sodium, ALT/GPT, AST/GOT, Alk Phos, Total Bilirubin, Total protein, Albumin, Complete blood count, hematocrit, Total Cholesterol, HDL/LDL cholesterol, Triglycerides, Insulin Free, Total Insulin, Hemoglobin A1C)
* current use of specific prescription medication(s): Coumadin, Opiates within 1 month of study, Chlorthalidone, Canagliflozin, Tetracycline, Heparin, Anti-psychotics, Chlorothiazide, Dapagliflozin, Cephalosporin, Eliquis, Lithium, Hydrochlorothiazide, Empagliflozin, Penicillin, Indapamide, Insulin, Quinolone, Metolazone, Acarbose, Lincomycin, Oral Steroids within 1 month of study, Cholestyramine, Amiloride hydrochloride, Miglitol, Macrolide, RA / psoriasis medications, Colesevelam, Spironolactone, Liraglutide, Sulfonamide, Medications for rheumatologic / hematologic active disease, Colestipol, Triamterene, Metformin, Glycopeptide Abs, Ezetimibe, Furosemide, Aminoglycosides, Fenofibrate, Bumetanide, HIV/HAART therapy, Statins, Proton-pump inhibitors
* inability to freely give informed consent in English
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05782218
Study Brief:
Protocol Section:
NCT05782218