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

Not Applicable

Recruiting

• Conditions: Diabetes
• Interventions: Other: DSF1; Other: DSF2; Other: Standard of Care (SOC)

• Registration Number: NCT06632002
• Lead Sponsor: Abbott Nutrition

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.

Study Timeline

• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-06
• Study First Posted: 2024-10-08
• Status Verified: 2025-01
• Study Start: 2025-01-02
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Product	DSF1	-
Experimental Product	Standard of Care (SOC)	-
Control Product	DSF2	-
Control Product	Standard of Care (SOC)	-

Primary Outcome Measures

Name	Time	Method
Serum albumin	Study Day 1 to Day 90	Change in serum albumin levels from baseline to Day 90

Secondary Outcome Measures

Name	Time	Method
Serum albumin	Study Days 45 and 90	Serum albumin levels
Malnutrition risk	Study Days 45 and 90	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, and high risk/score ≥ 2. Minimum value = 0, Maximum value = 6. Higher score indicates worse outcome, i.e., increased risk of malnutrition.
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

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan