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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT04313920
Eligibility Criteria:
Inclusion Criteria:
* Subject has voluntarily signed and dated an informed consent form and provided Health Insurance Portability and Accountability Act (HIPAA) authorization
* Subject is healthy or has pre-diabetes or type 2 diabetes
* Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum
* Subject's BMI is \> 18.5 kg/m2 and ≤ 40.0 kg/m2
* If subject is on a chronic medication, the dosage has been constant
* Subject states willingness to follow protocol
Exclusion Criteria:
* Subject uses exogenous insulin or Glucagon-like peptide-1 (GLP-1) receptor agonists for glucose control
* Subject has type 1 diabetes
* Subject has a history of diabetic ketoacidosis
* Subject has current infection; has had in-patient surgery, or corticosteroid treatment or antibiotics
* Subject has an active malignancy
* Subject has had a significant cardiovascular event ≤ six months or history of congestive heart failure
* Subject has end-stage organ failure or is status post organ transplant.
* Subject has a history of renal disease
* Subject has current hepatic disease
* Subject has a history of severe gastroparesis
* Subject has a chronic, contagious, infectious disease
* Subject has taken/is currently taking any herbals, dietary supplements, or medications that could profoundly affect blood glucose
* Subject has clotting or bleeding disorders
* Subject is known to be allergic or intolerant to any ingredient found in the study products
* Subject is a participant in another study that has not been approved as a concomitant study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04313920
Study Brief:
Protocol Section:
NCT04313920