Diabetes
Conditions
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.
Interventions
OTHERDSF1
220 mL
OTHERDSF2
220 mL
OTHERStandard of Care (SOC)
Standard of care
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply: 1. Has any of the following types of diabetes: 1. Type 1 diabetes 2. Type 2 diabetes 3. Prediabetes 2. Has MNA-SF score of ≤ 11 3. Serum albumin less than 4.0 g/dL 4. Energy or protein intake less than recommended 5. BMI less than 30.0 kg/m2 6. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the study 7. Female of childbearing potential to use an effective method of birth control 8. Chronic medication type and dose to be constant and maintained throughout the study 9. Willing to follow the protocol throughout the study 10. At least a two-week washout period between the completion of a previous research study and start in current study 11. 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: 1. Has a screening HbA1c level less than 5.0% or ≥ 10% 2. Has a current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks 3. Has active malignancy within the last 5 years 4. Has significant cardiovascular event within 6 months prior to the study or history of congestive heart failure 5. Has end-stage organ failure or is post-organ transplant 6. Has current or history of renal disease or on dialysis or severe gastroparesis 7. Has current hepatic disease 8. Has a recent acute infection, physiologic stress or trauma within 1 month prior to the study 9. 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 10. Has a chronic, contagious, infectious disease 11. 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 12. Taking any herbals, dietary supplements or medications during the past 4 weeks prior to the study 13. Using diabetes-specific formula(s) or oral nutritional supplement formula(s) in more than one eating occasion per week within the past 3 months 14. Has clotting or bleeding disorders 15. Has blood or blood-related diseases 16. Has received blood transfusion within the last 3 weeks 17. Has allergy or intolerance to the study product 18. Anticipated poor compliance to the study as assessed by the Investigator 19. Participates in another study that has not been approved as a concomitant study by Abbott Nutrition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum albumin | Study Day 1 to Day 90 | Change in serum albumin levels from baseline to Day 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum albumin | Study Days 45 and 90 | Serum albumin levels |
| Malnutrition risk | Study Days 45 and 90 | Mini Nutritional Assessment - Short Form (MNA®-SF) a validated screening tool for identifying elderly persons who are at risk for malnutrition, or who are already malnourished. It classifies participants into one of three categories: 1. Normal nutritional status/score =12 to 14 points, 2. At risk of malnutrition/score = 8 to 11 points, 3. Malnourished/score = 0 to 7 points. Minimum point = 0, Maximum points = 14. Lower score indicates worse outcome, i.e., at risk of malnutrition or malnourished. |
| Serum prealbumin | Study Days 45 and 90 | Serum prealbumin levels |
| Body weight | Study Days 45 and 90 | Body weight measured in kg |
| Body mass index (BMI) | Study Days 45 and 90 | Calculated as weight (kg)/height (m)2 |
| Mid arm circumference | Study Days 45 and 90 | Mid arm circumference measured in cm |
| Mid arm muscle circumference | Study Days 45 and 90 | Mid arm muscle circumference measured in cm |
| Triceps skinfold thickness | Study Days 45 and 90 | Triceps skinfold thickness measured in mm |
| Calf circumference | Study Days 45 and 90 | Calf circumference measured in cm |
| Waist circumference | Study Days 45 and 90 | Waist circumference measured in cm |
| Hip circumference | Study Days 45 and 90 | Hip circumference measured in cm |
| Waist-to-hip-ratio | Study Days 45 and 90 | Waist-to-hip-ratio |
| Hemoglobin A1c (HbA1c) | Study Days 45 and 90 | HbA1c levels |
| Fasting plasma glucose | Study Days 45 and 90 | Fasting plasma glucose levels |
| 2-hour postprandial glucose | Study Days 45 and 90 | 2-hour postprandial glucose levels |
| Glycated albumin | Study Days 45 and 90 | Glycated albumin levels |
| Triglycerides | Study Days 45 and 90 | Triglycerides levels |
| High density lipoprotein (HDL) cholesterol | Study Days 45 and 90 | HDL cholesterol levels |
| Low density lipoprotein (LDL) cholesterol | Study Days 45 and 90 | LDL cholesterol levels |
Countries
Taiwan
Contacts
STUDY_CHAIRMandy Yen Ling Ow, PhD
Abbott Nutrition
Outcome results
None listed