Effects of a Fiber-enriched, Sodium-controlled Enteral Formula on Glycemic Status and Blood Pressure in Tube-fed Long-term Care Residents With Diabetes: a Prospective Single-arm Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Systolic and diastolic blood pressure
研究概览
简要总结
This study aims to evaluate the effects of a fiber-enriched, sodium-controlled enteral nutrition formula on glycemia, blood pressure, and nutritional status in long-term care residents with diabetes receiving tube feeding. Participants receive the enteral formula as their sole source of nutrition for 3 months, followed by a 1-month post-intervention follow-up period. Clinical outcomes including metabolic parameters, blood pressure, and safety indicators are assessed.
详细描述
This prospective single-arm interventional study was conducted in long-term care residents with diabetes receiving tube feeding. The study protocol was approved by the Institutional Review Board of Taipei Medical University (TMU-IRB-201504036).
Participants received a standardized enteral nutrition formula enriched with dietary fiber and designed with controlled sodium content, providing approximately 1500 kcal/day as the sole nutritional source. The intervention lasted for 3 months, followed by a 1-month observation period.
Clinical assessments were conducted at baseline (M0), post-intervention (M1), and follow-up (M2). Outcomes included glycemic parameters (blood glucose, HbA1c), blood pressure, nutritional biomarkers (albumin, total protein), lipid profile, liver and kidney function, hematological indices, electrolyte levels, and gastrointestinal tolerance.
This study aims to explore whether targeted nutritional composition, including fiber enrichment and sodium control, can contribute to maintaining metabolic and cardiovascular stability in tube-fed residents with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20-85 years
- •Diagnosed with diabetes mellitus (HbA1c ≥ 6%)
- •Receiving tube feeding for at least 3 months
- •Clinically stable condition
排除标准
- •Terminal cancer
- •Liver cirrhosis
- •Severe renal failure or uremia
- •Lactose intolerance
- •Any condition deemed unsuitable by investigators
结局指标
主要结局
Systolic and diastolic blood pressure
时间窗: baseline, 3 months, and 4 months
Blood pressure will be measured in millimeters of mercury (mmHg), including systolic and diastolic blood pressure. Lower values indicate better blood pressure control. Participants will be assessed at baseline, after the 3-month intervention period, and at 4 months during follow-up.
Fasting blood glucose
时间窗: Baseline, 3 months, and 4 months
Fasting blood glucose will be measured in mg/dL, with lower values indicating better glycemic control. Participants will be assessed at baseline, after the 3-month intervention period, and at 4 months during follow-up.
Glycated hemoglobin (HbA1c)
时间窗: Baseline, 3 months, and 4 months
Glycated hemoglobin (HbA1c) will be measured as a percentage (%), with lower values indicating better glycemic control.
Serum albumin
时间窗: Baseline, 3 months, and 4 months
Serum albumin will be measured in grams per deciliter (g/dL), with higher values indicating better nutritional status.
Serum total protein
时间窗: Baseline, 3 months, and 4 months
Serum total protein will be measured in grams per deciliter (g/dL), with higher values indicating better nutritional status.
Total cholesterol
时间窗: Baseline, 3 months, and 4 months
Total cholesterol will be measured in milligrams per deciliter (mg/dL), with lower values indicating a better lipid profile.
Triglycerides
时间窗: Baseline, 3 months, and 4 months
Triglycerides will be measured in milligrams per deciliter (mg/dL), with lower values indicating a better lipid profile.
High-density lipoprotein cholesterol (HDL-C)
时间窗: Baseline, 3 months, and 4 months
High-density lipoprotein cholesterol (HDL-C) will be measured in milligrams per deciliter (mg/dL), with higher values indicating a better lipid profile.
Low-density lipoprotein cholesterol (LDL-C)
时间窗: Baseline, 3 months, and 4 months
Low-density lipoprotein cholesterol (LDL-C) will be measured in milligrams per deciliter (mg/dL), with lower values indicating a better lipid profile.
Geriatric Nutritional Risk Index (GNRI)
时间窗: Baseline, 3 months, and 4 months
The Geriatric Nutritional Risk Index (GNRI) is calculated using serum albumin and body weight relative to ideal body weight. Lower GNRI values indicate a higher risk of malnutrition.
Subjective Global Assessment (SGA)
时间窗: Baseline, 3 months, and 4 months
The Subjective Global Assessment (SGA) is a clinical tool used to assess nutritional status, classifying patients into categories (A: well-nourished, B: moderately malnourished, C: severely malnourished).
次要结局
- Aspartate aminotransferase (AST)(Baseline, 3 months, and 4 months)
- Alanine aminotransferase (ALT)(Baseline, 3 months, and 4 months)
- Blood urea nitrogen (BUN)(Baseline, 3 months, and 4 months)
- Serum creatinine(Baseline, 3 months, and 4 months)
- Gamma-glutamyl transferase (GGT)(Baseline, 3 months, and 4 months)
- Total bilirubin(Baseline, 3 months, and 4 months)
- Lactate dehydrogenase (LDH)(Baseline, 3 months, and 4 months)
- Creatine phosphokinase (CPK)(Baseline, 3 months, and 4 months)
- Serum sodium(Baseline, 3 months, and 4 months)
- Serum potassium(Baseline, 3 months, and 4 months)
- Serum chloride(Baseline, 3 months, and 4 months)
- Serum calcium(Baseline, 3 months, and 4 months)
- Serum phosphorus(Baseline, 3 months, and 4 months)
- Serum magnesium(Baseline, 3 months, and 4 months)
- Bowel movement frequency(Baseline, 3 months, and 4 months)
- Complete blood count (CBC)(Baseline, 3 months, and 4 months)
- Urinary urea nitrogen (UUN)(Baseline, 3 months, and 4 months)
- Urinary sodium(Baseline, 3 months, and 4 months)
- Urine osmolality(Baseline, 3 months, and 4 months)
- Urinalysis(Baseline, 3 months, and 4 months)
研究者
Suh-Ching, Yang
Director, Research Center of Geriatric Nutrition, Taipei Medical University
Taipei Medical University