A Randomized, Double-blind, Non-inferiority Trial of a New Diabetes-specific Formula Compared to an Existing Diabetes-specific Formula on Nutritional Outcomes in Individuals With Diabetes Who Require Nutritional Support
Overview
- Phase
- Not Applicable
- Intervention
- DSF2
- Conditions
- Diabetes
- Sponsor
- Abbott Nutrition
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Serum albumin
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
Brief Summary
The study aims to demonstrate the non-inferiority of diabetes-specific formula (DSF)1 compared to DSF2 in individuals with type 1 diabetes, type 2 diabetes or prediabetes and who are at nutritional risk.
Detailed Description
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Control Product
Intervention: DSF2
Control Product
Intervention: Standard of Care (SOC)
Experimental Product
Intervention: DSF1
Experimental Product
Intervention: Standard of Care (SOC)
Outcomes
Primary Outcomes
Serum albumin
Time Frame: Study Day 1 to Day 90
Change in serum albumin levels from baseline to Day 90
Secondary Outcomes
- Serum albumin(Study Days 45 and 90)
- Hip circumference(Study Days 45 and 90)
- Malnutrition risk(Study Days 45 and 90)
- Waist circumference(Study Days 45 and 90)
- Serum prealbumin(Study Days 45 and 90)
- Body weight(Study Days 45 and 90)
- Body mass index (BMI)(Study Days 45 and 90)
- Mid arm circumference(Study Days 45 and 90)
- Mid arm muscle circumference(Study Days 45 and 90)
- Triglycerides(Study Days 45 and 90)
- Triceps skinfold thickness(Study Days 45 and 90)
- Calf circumference(Study Days 45 and 90)
- Glycated albumin(Study Days 45 and 90)
- Waist-to-hip-ratio(Study Days 45 and 90)
- Hemoglobin A1c (HbA1c)(Study Days 45 and 90)
- Fasting plasma glucose(Study Days 45 and 90)
- 2-hour postprandial glucose(Study Days 45 and 90)
- High density lipoprotein (HDL) cholesterol(Study Days 45 and 90)
- Low density lipoprotein (LDL) cholesterol(Study Days 45 and 90)