NCT06632002

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Abbott Nutrition · Industry
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
OTHER	DSF1	220 mL
OTHER	DSF2	220 mL
OTHER	Standard of Care (SOC)	Standard of care

Timeline

• Start date: 2025-01-02
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-10-08
• Last updated: 2026-03-09

Locations

1 site across 1 country: Taiwan