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

NCT06632002 | Active Not Recruiting

• 1 other identifier: BL80
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Serum albumin

  Change in serum albumin levels from baseline to Day 90

  Study Day 1 to Day 90

Secondary Outcomes (20)

• Serum albumin

  Study Days 45 and 90

• Malnutrition risk

  Study Days 45 and 90

• Malnutrition risk

  Study Days 45 and 90

• Serum prealbumin

  Study Days 45 and 90

• Body weight

  Study Days 45 and 90

Other Outcomes (4)

• Energy, macronutrient and micronutrient intakes

  Study Days 45 and 90

• Energy, macronutrient and micronutrient adequacy

  Study Days 45 and 90

• Product intake compliance

  Study Days 90

Study Arms (2)

Experimental Product

EXPERIMENTAL

Other: DSF1; Other: Standard of Care (SOC)

Control Product

OTHER

Other: DSF2; Other: Standard of Care (SOC)

Interventions

Standard of Care (SOC) OTHER

Standard of care

Control Product; Experimental Product

DSF1 OTHER

220 mL

Experimental Product

DSF2 OTHER

220 mL

Control Product

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Has any of the following types of diabetes:
• Type 1 diabetes
• Type 2 diabetes
• Prediabetes
• Has MNA-SF score of ≤ 11
• Serum albumin less than 4.0 g/dL
• Energy or protein intake less than recommended
• BMI less than 30.0 kg/m2
• Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the study
• Female of childbearing potential to use an effective method of birth control
• Chronic medication type and dose to be constant and maintained throughout the study
• Willing to follow the protocol throughout the study
• At least a two-week washout period between the completion of a previous research study and start in current study
• Willing to refrain from taking non-study diabetes-specific formula over the course of the study.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Has a screening HbA1c level less than 5.0% or ≥ 10%
• Has a current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks
• Has active malignancy within the last 5 years
• Has significant cardiovascular event within 6 months prior to the study or history of congestive heart failure
• Has end-stage organ failure or is post-organ transplant
• Has current or history of renal disease or on dialysis or severe gastroparesis
• Has current hepatic disease
• Has a recent acute infection, physiologic stress or trauma within 1 month prior to the study
• 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
• Has a chronic, contagious, infectious disease
• 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
• Taking any herbals, dietary supplements or medications during the past 4 weeks prior to the study
• Using diabetes-specific formula(s) or oral nutritional supplement formula(s) in more than one eating occasion per week within the past 3 months
• Has clotting or bleeding disorders

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Chung Shan Medical University

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mandy Yen Ling Ow, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: January 2, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)