Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes Who Require Nutritional Support

This is a randomized, double-blind, parallel, non-inferiority study. Eligible participants will be randomly allocated (at 1:1 ratio) to one of two groups: DSF1 (experimental group) or DSF2 (control group). Both groups will incorporate one serving of the DSF into their daily diet, in addition to receiving standard of care for diabetes. The total expected duration of the study is up to 104 days, including a run-in period of up to 14 days, followed by an intervention period of 90 days. At Day 1, participants will be randomized into one of the two groups (n = 50 per group): DSF1 or DSF2. Participants will start the intervention on Day 1 and complete the intervention on Day 90.

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

• Has any of the following types of diabetes:

• Type 1 diabetes
• Type 2 diabetes
• Prediabetes
• Has MNA-SF score of ≤ 11
• Serum albumin less than 4.0 g/dL
• Energy or protein intake less than recommended
• BMI less than 30.0 kg/m2
• Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the study
• Female of childbearing potential to use an effective method of birth control
• Chronic medication type and dose to be constant and maintained throughout the study
• Willing to follow the protocol throughout the study
• At least a two-week washout period between the completion of a previous research study and start in current study
• Willing to refrain from taking non-study diabetes-specific formula over the course of the study.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• Has a screening HbA1c level less than 5.0% or ≥ 10%
• Has a current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks
• Has active malignancy within the last 5 years
• Has significant cardiovascular event within 6 months prior to the study or history of congestive heart failure
• Has end-stage organ failure or is post-organ transplant
• Has current or history of renal disease or on dialysis or severe gastroparesis
• Has current hepatic disease
• Has a recent acute infection, physiologic stress or trauma within 1 month prior to the study
• Has had bariatric surgery including gastric balloon; history of gastrointestinal disease or intestinal surgery that can interfere with consumption or digestion or absorption of study product
• Has a chronic, contagious, infectious disease
• 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 procedures
• Taking any herbals, dietary supplements or medications during the past 4 weeks prior to the study
• Using diabetes-specific formula(s) or oral nutritional supplement formula(s) in more than one eating occasion per week within the past 3 months
• Has clotting or bleeding disorders
• Has blood or blood-related diseases
• Has received blood transfusion within the last 3 weeks
• Has allergy or intolerance to the study product
• Anticipated poor compliance to the study as assessed by the Investigator
• Participates in another study that has not been approved as a concomitant study by Abbott Nutrition