NCT06632002已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Serum albumin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Has blood or blood-related diseases
- •Has received blood transfusion within the last 3 weeks
- •Has allergy or intolerance to the study product
- •Anticipated poor compliance to the study as assessed by the Investigator
- •Participates in another study that has not been approved as a concomitant study by Abbott Nutrition
研究组 & 干预措施
Experimental Product
Experimental
干预措施: Standard of Care (SOC) (Other)
Control Product
Other
干预措施: DSF2 (Other)
Control Product
Other
干预措施: Standard of Care (SOC) (Other)
Experimental Product
Experimental
干预措施: DSF1 (Other)
结局指标
主要结局
Serum albumin
时间窗: Study Day 1 to Day 90
Change in serum albumin levels from baseline to Day 90
次要结局
- Serum albumin(Study Days 45 and 90)
- Hip circumference(Study Days 45 and 90)
- Malnutrition risk(Study Days 45 and 90)
- Waist circumference(Study Days 45 and 90)
- Serum prealbumin(Study Days 45 and 90)
- Body weight(Study Days 45 and 90)
- Body mass index (BMI)(Study Days 45 and 90)
- Mid arm circumference(Study Days 45 and 90)
- Mid arm muscle circumference(Study Days 45 and 90)
- Triglycerides(Study Days 45 and 90)
- Triceps skinfold thickness(Study Days 45 and 90)
- Calf circumference(Study Days 45 and 90)
- Glycated albumin(Study Days 45 and 90)
- Waist-to-hip-ratio(Study Days 45 and 90)
- Hemoglobin A1c (HbA1c)(Study Days 45 and 90)
- Fasting plasma glucose(Study Days 45 and 90)
- 2-hour postprandial glucose(Study Days 45 and 90)
- High density lipoprotein (HDL) cholesterol(Study Days 45 and 90)
- Low density lipoprotein (LDL) cholesterol(Study Days 45 and 90)
- Serum albumin(Study Days 45 and 90)
- Serum prealbumin(Study Days 45 and 90)
- High density lipoprotein (HDL) cholesterol(Study Days 45 and 90)
- Low density lipoprotein (LDL) cholesterol(Study Days 45 and 90)
- Malnutrition risk(Study Days 45 and 90)
- Body weight(Study Days 45 and 90)
- Body mass index (BMI)(Study Days 45 and 90)
- Mid arm circumference(Study Days 45 and 90)
- Mid arm muscle circumference(Study Days 45 and 90)
- Triceps skinfold thickness(Study Days 45 and 90)
- Calf circumference(Study Days 45 and 90)
- Waist circumference(Study Days 45 and 90)
- Hip circumference(Study Days 45 and 90)
- Waist-to-hip-ratio(Study Days 45 and 90)
- Hemoglobin A1c (HbA1c)(Study Days 45 and 90)
- Fasting plasma glucose(Study Days 45 and 90)
- 2-hour postprandial glucose(Study Days 45 and 90)
- Glycated albumin(Study Days 45 and 90)
- Triglycerides(Study Days 45 and 90)
研究者
研究点 (1)
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