Comparing two diabetes-specific nutritional formulas for individuals at risk of undernutrition
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 and at Risk of Undernutrition
This study is testing if two different diabetes-specific nutritional formulas can help people with type 1 or type 2 diabetes, or prediabetes, who are at risk of not getting enough nutrition, and sees if one works just as well as the other.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Abbott Nutrition Industry-sponsored |
| Locations | 1 site (Taichung) |
| Trial ID | NCT06632002 on ClinicalTrials.gov |
What this trial studies
This study evaluates the non-inferiority of two diabetes-specific formulas (DSF1 and DSF2) in individuals with type 1 diabetes, type 2 diabetes, or prediabetes who are at risk of undernutrition. Participants will be randomly assigned to receive either DSF1 or DSF2, along with standard diabetes care, over a 90-day intervention period following a 14-day run-in phase. The study aims to determine if DSF1 is as effective as DSF2 in improving nutritional outcomes for these individuals.
Who should consider this trial
Good fit: Ideal candidates include individuals with type 1 or type 2 diabetes or prediabetes who have a MUST score of 1 or higher and are at risk of undernutrition.
Not a fit: Patients who do not have diabetes or prediabetes, or those with a MUST score below 1, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for effective nutritional interventions that improve health outcomes for individuals with diabetes at risk of malnutrition.
How similar studies have performed: Previous studies have shown promising results with diabetes-specific nutritional interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 Malnutrition Universal Screening Tool (MUST) score of ≥ 1 3. Serum albumin less than 3.5 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 5.7% 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
Where this trial is running
Taichung
- Chung Shan Medical University — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Mei Qi Mak, BSc
- Email: meiqi.mak@abbott.com
- Phone: +65 68016272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.