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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT01850134
Eligibility Criteria:
Inclusion Criteria:
* Subjects will be eligible for the study if they meet all of the following inclusion criteria:
1. Diagnosis of Type 2 Diabetes.
2. Age between 18 and 75 years.
3. HbA1c \> 6.0 but ≤ 8.5
4. If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
5. BMI \> 18.5 kg/m2 and \< 40.0 kg/m2.
6. Chronic medication dosage must be stable for at least two months prior to Screening Visit.
7. Subject states that they are a habitual consumer of a morning meal.
Exclusion Criteria:
* Subjects will be excluded from the study if they meet any of the following criteria:
1. Use of exogenous insulin or GLP-1 agonists for glucose control.
2. Diagnosis of Type 1 diabetes.
3. History of diabetic ketoacidosis.
4. Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
5. Active malignancy.
6. Significant cardiovascular event \< 12 weeks prior to study entry.
7. End stage organ failure or status post organ transplant.
8. Active metabolic, hepatic, or gastrointestinal disease.
9. Chronic, contagious, infectious disease.
10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
11. History of fainting or other adverse reactions in response to blood collection.
12. Clotting or bleeding disorders.
13. Allergy or intolerance to study product ingredient.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01850134
Study Brief:
Protocol Section:
NCT01850134