Diabetes-Specific Formula in Individuals With Type 2 Diabetes

Exclusion Criteria

• •1. Participant has a screening HbA1c level \<7% or ≥ 10%.
• •2. Participant uses exogenous insulin or GLP-1 agonists or DPP-4 inhibitors for glucose control.
• •3. Participant has confirmed type 1 diabetes and/or had history of diabetic ketoacidosis.
• •4. Participant has current infection (requiring medication), inpatient surgery or received systemic corticosteroid treatment (with the exception of inhaled (includes nasal), topical, and ophthalmic steroids) in the last 3 months; or received antibiotics in the last 3 weeks.
• •5. Participant has active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
• •6. Participant has significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure.
• •7. Participant has end stage organ failure (such as end stage renal disease) or was post organ transplant.
• •8. Participant has a history of renal disease or severe gastroparesis.
• •9. Participant has current hepatic disease.
• •10. Participant has had bariatric surgery including gastric balloon; history of gastrointestinal disease (e.g., Crohn's, colitis, celiac) or intestinal surgery that can interfere with consumption or digestion or absorption of study product.
• •11. Participant has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV.
• •12. Participant has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the principal investigator or study physician.
• •13. Participant is taking any herbals, dietary supplements, or medications, other than allowed anti-hyperglycemic medications, during the past four weeks prior to screening visit that could profoundly affect (in the opinion of the principal investigator) blood glucose or appetite (examples include orlistat, contrive, qsymia, belviq, incretins, cannabis).
• •14. Participant uses diabetes-specific formula(s), (e.g. Glucerna, Nestle Nutren Diabetes, Kalbe Diabetasol, Appeton Nutrition Wellness 60+ Diabetic, ForSure, Penta Sure DM, Resurge DM, Diben, Diasip, etc.) defined as more than one eating occasion per week in the last three months.
• •15. Participant has clotting or bleeding disorders. The use of Plavix® or a similar anticoagulant drug with no reported difficulty during blood draws is allowed and participant is able to maintain medication number, type and dose throughout the duration of study.
• •16. Participant participates in another study that has not been approved as a concomitant study by AN.
• •17. Participant has an allergy or intolerance to any ingredient in the study product, as reported by the participant.