Supplementation With Nutrients Modulating IGF-1 Negatively Correlated With Changes in the Levels of Proinflammatory Cytokines in Community-dwelling Elderly People at Risk of Undernutrition
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Prealbumin (mg/dL)
研究概览
简要总结
The purpose of this study was to determine the improvement in nutritional status, especially in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the circulating cytokine levels, after providing extra protein and energy contents to community-dwelling older adults at risk of undernutrition.
详细描述
Sixty of aged over 65 years, living independently in the community for elderly people, nondiabetic subjects with serum prealbumin of under 30 mg/dL and BMI under 25 kg/m2 were recruited. The subjects were followed for a 2-week pre-intervention period, followed by an intervention period, which they received 2 cartons of liquid oral nutritional supplementation daily for 2 weeks.
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
- 65 Years 至 86 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •voluntarily agree to participate and sign in informed consent form
- •aged 65 years or older
- •a serum prealbumin level≤30 mg/dL and a BMI<25 kg/m2
排除标准
- •inability to perform oral ingestion
- •known allergies to milk or eggs
- •an inability to communicate, such as those with Alzheimer's disease
- •malabsorption syndrome, a history of gastrectomy or enterectomy
- •diabetes, liver disease, renal disease, neurological disease, pancreatitis, malignancy, cardiovascular or cerebrovascular disease, metabolic syndrome
- •any other disease requiring treatment, medication or alcohol abuse
- •any condition that the investigator believes may put the subjects at under risk
结局指标
主要结局
Prealbumin (mg/dL)
时间窗: at post-treatment (week 2)
Transferrin (mg/dL)
时间窗: at post-treatment (week 2)
次要结局
- Weight (kg)(4 weeks)
- Serum albumin (g/dL)(4 weeks)
- Insulin growth factor-1 (ng/mL)(4 weeks)
- Osmolality (mOsm/kgH2O)(4 weeks)
- Body mass index (kg/m2)(4 weeks)