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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT05934357
Eligibility Criteria:
Inclusion Criteria:
* Adults ages 22-75 years
* BMI between 18.5 and 39.9 kg/m2
* Ability to drop-off 1 fecal sample within 15 minutes of defecation
* Ability to pick-up meals daily
* Ability to collect fecal and urine samples daily
* Fasting glucose of \<126 mg/dL
Exclusion Criteria:
* Wheat allergy or intolerance
* Any food allergies or intolerances
* Prior diagnosis of metabolic or gastrointestinal disease (kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, diabetes requiring medication)
* Women that are pregnant, had a baby within the last 12 months, or are lactating.
* Individuals that smoke, use tobacco, abuse drugs, or consume \> 2 alcoholic beverages per day.
* \>5% weight change in the past month or \>10% change in the past year
* Oral antibiotics during the previous 6 weeks
* History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery
* Are unable or unwilling to consume the experimental meals/snacks.
* Taking certain medications (Orlistat, bile binding resins, insulin, oral hypoglycemic agents, laxatives)
* Concurrent enrollment in another dietary, exercise, or medication study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
75 Years
Study:
NCT05934357
Study Brief:
Protocol Section:
NCT05934357