Clinical trial NCT06632002: Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes and at Risk of Undernutrition
Official title: 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 and at Risk of Undernutrition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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 Malnutrition Universal Screening Tool (MUST) score of ≥ 1
3. Serum albumin less than 3.5 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 5.7% 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

Primary outcomes:
measure: Serum albumin
timeFrame: Study Day 1 to Day 90
Secondary outcomes:
measure: Serum albumin
timeFrame: Study Days 45 and 90
measure: Malnutrition risk
timeFrame: Study Days 45 and 90
measure: Serum prealbumin
timeFrame: Study Days 45 and 90
measure: Body weight
timeFrame: Study Days 45 and 90
measure: Body mass index (BMI)
timeFrame: Study Days 45 and 90
measure: Mid arm circumference
timeFrame: Study Days 45 and 90
measure: Mid arm muscle circumference
timeFrame: Study Days 45 and 90
measure: Triceps skinfold thickness
timeFrame: Study Days 45 and 90
measure: Calf circumference
timeFrame: Study Days 45 and 90
measure: Waist circumference
timeFrame: Study Days 45 and 90
measure: Hip circumference
timeFrame: Study Days 45 and 90
measure: Waist-to-hip-ratio
timeFrame: Study Days 45 and 90
measure: Hemoglobin A1c (HbA1c)
timeFrame: Study Days 45 and 90
measure: Fasting plasma glucose
timeFrame: Study Days 45 and 90
measure: 2-hour postprandial glucose
timeFrame: Study Days 45 and 90
measure: Glycated albumin
timeFrame: Study Days 45 and 90
measure: Triglycerides
timeFrame: Study Days 45 and 90
measure: High density lipoprotein (HDL) cholesterol
timeFrame: Study Days 45 and 90
measure: Low density lipoprotein (LDL) cholesterol
timeFrame: Study Days 45 and 90
Other outcomes:
measure: Energy, macronutrient and micronutrient intakes
timeFrame: Study Days 45 and 90
measure: Energy, macronutrient and micronutrient adequacy
timeFrame: Study Days 45 and 90
measure: Product intake compliance
timeFrame: Study Days 90
measure: Adverse events
timeFrame: Study Day 1 to Day 90
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Abbott Nutrition
name: Mandy Yen Ling Ow, PhD
role: STUDY_CHAIR
References: