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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes
• Intervention / Treatment: Other: DSF1; Other: Standard of Care (SOC); Other: DSF2

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Product	Other: DSF1; 220 mL; Other: Standard of Care (SOC); Standard of care
Other: Control Product	Other: Standard of Care (SOC); Standard of care; Other: DSF2; 220 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum albumin	Change in serum albumin levels from baseline to Day 90	Study Day 1 to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum albumin	Serum albumin levels	Study Days 45 and 90
Serum prealbumin	Serum prealbumin levels	Study Days 45 and 90
Body weight	Body weight measured in kg	Study Days 45 and 90
Body mass index (BMI)	Calculated as weight (kg)/height (m)2	Study Days 45 and 90
Mid arm circumference	Mid arm circumference measured in cm	Study Days 45 and 90
Mid arm muscle circumference	Mid arm muscle circumference measured in cm	Study Days 45 and 90
Triceps skinfold thickness	Triceps skinfold thickness measured in mm	Study Days 45 and 90
Calf circumference	Calf circumference measured in cm	Study Days 45 and 90
Waist circumference	Waist circumference measured in cm	Study Days 45 and 90
Hip circumference	Hip circumference measured in cm	Study Days 45 and 90
Waist-to-hip-ratio	Waist-to-hip-ratio	Study Days 45 and 90
Hemoglobin A1c (HbA1c)	HbA1c levels	Study Days 45 and 90
Fasting plasma glucose	Fasting plasma glucose levels	Study Days 45 and 90
2-hour postprandial glucose	2-hour postprandial glucose levels	Study Days 45 and 90
Glycated albumin	Glycated albumin levels	Study Days 45 and 90
Triglycerides	Triglycerides levels	Study Days 45 and 90
High density lipoprotein (HDL) cholesterol	HDL cholesterol levels	Study Days 45 and 90
Low density lipoprotein (LDL) cholesterol	LDL cholesterol levels	Study Days 45 and 90
Malnutrition risk	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: Normal nutritional status/score =12 to 14 points,; At risk of malnutrition/score = 8 to 11 points,; 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.	Study Days 45 and 90
Malnutrition risk	Malnutrition Universal Screening Tool (MUST) is a widely used screening tool for malnutrition. It classifies participants into one of three nutrition status categories: Low risk/score = 0,; Medium risk/score = 1,; High risk/score ≥ 2. Minimum value = 0, Maximum value = 6. Higher score indicates worse outcome, i.e., increased risk of malnutrition.	Study Days 45 and 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy, macronutrient and micronutrient intakes	A 3-day Dietary Record (two weekdays and one weekend day) will be completed by participant for the week prior Study Day 45 and 90 and evaluated by a dietitian. Nutrient analysis will be performed using a dietary analysis program.	Study Days 45 and 90
Energy, macronutrient and micronutrient adequacy	Nutrient adequacy will be determined by comparing nutrient intakes (outcome No. 21) against sex- and age- specific local recommended nutrient intakes (RNI).	Study Days 45 and 90
Product intake compliance	Compliance to study product prescribed over 90-day intervention period	Study Days 90
Adverse events	Reported adverse events for assessment of safety and tolerability	Study Day 1 to Day 90

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Mandy Yen Ling Ow, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 6, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: BL80

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No