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:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT05384106
Eligibility Criteria:
Inclusion Criteria:
* Males and females, 18 to 65 years of age
* BMI 18 to \<35.0 kg/m2, inclusive
* Weight ≥ 110 lbs
* Subject is judged to be in good health on the basis of medical history
* Subject is willing to fast for 12 hours prior to study start
* Subject is willing to avoid alcohol and intense physical activity the day prior to and on the day of testing
* Subject is capable of giving informed consent and complying with all study procedures/requirements.
Exclusion Criteria:
* Previous GI disorders (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, or gastroparesis)
* Gastroenteritis in the 2 weeks preceding the study
* Diabetes
* Weight \<110 lbs
* History of alcohol or drug abuse
* Previous diagnosis of neurological disorders, depression, or mental illness with psychosis
* Unexplained alarm features (i.e., unintentional weight loss \>10% body weight in the last 3 months, fevers, or blood in stools)
* Use of an antibiotic or any medication impacting gut transit during the 2 weeks before the study
* Constipation or diarrhea (defined as, on average, less than 3 stools per week or more than 3 stools per day, respectively)
* Allergy to tree nuts
* Women who are pregnant or breastfeeding
* Persons with medical conditions affecting the pancreas, liver, thyroid, or gall bladder.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05384106
Study Brief:
Protocol Section:
NCT05384106