Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes and at Risk of Undernutrition

Last updated: January 27, 2025
Sponsor: Abbott Nutrition
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diet And Nutrition

Diabetic Vitreous Hemorrhage

Treatment

DSF1

Standard of Care (SOC)

DSF2

Clinical Study ID

NCT06632002
BL80
  • Ages 21-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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:

  2. Type 1 diabetes

  3. Type 2 diabetes

  4. Prediabetes

  5. Has Malnutrition Universal Screening Tool (MUST) score of ≥ 1

  6. Serum albumin less than 3.5 g/dL

  7. Energy or protein intake less than recommended

  8. BMI less than 30.0 kg/m2

  9. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the study

  10. Female of childbearing potential to use an effective method of birth control

  11. Chronic medication type and dose to be constant and maintained throughout the study

  12. Willing to follow the protocol throughout the study

  13. At least a two-week washout period between the completion of a previous research study and start in current study

  14. 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

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: DSF1
Phase:
Study Start date:
January 02, 2025
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Chung Shan Medical University

    Taichung, 40201
    Taiwan

    Active - Recruiting

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