Study of a Carbohydrate Drink in Adults

Postprandial Gastric Emptying and Glycemic Response to a Pre-Operative Carbohydrate Drink in Adults With Pre-diabetes and Type II Diabetes Mellitus

The objective of this study is to determine the postprandial glycemic response and rates of gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes following oral ingestion of carbohydrate.

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