Evaluation of a Nutritional Product for People With Type 2 Diabetes

Inclusion criteria

• Subjects will be eligible for the study if they meet all of the following inclusion criteria:

• Diagnosis of Type 2 Diabetes.
• Age between 18 and 75 years.
• HbA1c > 6.0 but ≤ 8.5
• 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.
• BMI is > 18.5 kg/m2 and < 40.0 kg/m2.
• Chronic medication dosage must be stable for at least two months prior to Screening Visit.
• 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:

• Use of exogenous insulin or GLP-1 agonists for glucose control.
• Diagnosis of Type 1 diabetes.
• History of diabetic ketoacidosis.
• 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.
• Active malignancy.
• Significant cardiovascular event < 12 weeks prior to study entry.
• End stage organ failure or status post organ transplant.
• Active metabolic, hepatic, or gastrointestinal disease.
• Chronic, contagious, infectious disease.
• Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
• History of fainting or other adverse reactions in response to blood collection.
• Clotting or bleeding disorders.
• Allergy or intolerance to study product ingredient.