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

Launched by ABBOTT NUTRITION · Oct 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different diabetes-specific formulas (DSF1 and DSF2) on the nutritional health of individuals with type 1 diabetes, type 2 diabetes, or prediabetes who are at risk of not getting enough nutrients. The goal is to see if one formula is just as effective as the other in helping improve nutrition for these individuals. The trial is currently recruiting participants aged 18 to 80 who have specific health conditions, like having a certain level of malnutrition or low protein intake, and a body mass index (BMI) under 30.

If you or someone you know is interested in joining, it's essential to meet certain criteria, such as having a diabetes diagnosis and being willing to follow the study guidelines. Participants can expect to be part of a research study that aims to improve nutrition for people with diabetes and will need to refrain from using other diabetes-specific formulas during the study. It’s also important to note that individuals with certain health issues or recent medical treatments may not be eligible to participate. Overall, this trial could contribute valuable information to help manage nutritional needs for those living with diabetes.

Gender

ALL

Eligibility criteria

• • 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