Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD:a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in nutritional status
研究概览
简要总结
Insufficient energy intake and systematic inflammation lead to malnutrition in patients with chronic obstructive pulmonary disease (COPD). Nutritional supplementation improves the patients'nutritional status by increasing energy intake and providing anti-inflammatory elements，which can relieve the patients' symptoms and delay the disease progression.
详细描述
Malnutrition is very common in patients with COPD. The main reasons include short intake of energy and systematic inflammation. In our randomized and controlled clinical trial, patients will be divided into two groups: the experimental group and the control group. Patients in the experimental group will be provided nutritional supplements in addition to usual diet every day for three months and patients in the controlled group with usual diet. According to the changes of patients' body composition, anthropometrics, inflammatory markers, lung function, respiratory muscle function, exercise capacity, degree of dyspnea and health related quality of life(HRQL) after intervention，the nutritional status and inflammation status are assessed, which contributes to the prediction of prognosis. The nutritional supplements is a kind of oral liquid composed of proteins, omega-3 fatty acids, carbohydrate, vitamins, which provides about 260 kcal energy per 200ml. The patients from the interventional group need drink the nutritional supplements according to the estimated energy intake and a record should be made everyday. The patients will be followed up regularly by the researcher.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from Zhujiang Hospital affiliated from Southern Medical University
- •Patients aged between 40 and 90 years old
- •Patients gendered into male or female
- •Patients with pulmonary function test of FEV1/FVC<70% and FEV1<80% predicted
- •Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients ≥ 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last month; FFMI <15 kg/m2 (women) or <16 kg/m2 (men)
- •Patients able to answer question
- •Patient able to eat and drink
- •Patients who signed informed consent
排除标准
- •Patients with signs of an airway infection
- •Patients with malignant disorders
- •Patients with recent surgery
- •Patients with gastrointestinal ,cardiovascular diseases,neurological diseases or endocrine disease
- •Patients with bullae lung
- •patients treated with oral steroids or immunosuppressors
- •Patients requiring other nutritional supplements or parenteral nutrition
- •Patients suffering from acute exacerbation over the previous 4 weeks
- •Patients with lack of motivation or poor compliance
结局指标
主要结局
Changes in nutritional status
时间窗: Before and three months after nutrition supplementation
Differences in weight,muscle mass(MM),fat mass(FM),free fat mass(FFM),protein，body mass index(BMI),free fat mass index(FFMI) evaluated by bio-impedance measuring technology.
Changes in the serum levels of inflammatory markers
时间窗: Before and three months after nutrition supplementation
Changes in the serum levels of tumor necrosis factor-α(TNF-α)、interleukin-6（IL-6）、C-reactive protein(CRP) by laboratory technology.
次要结局
- Changes in pulmonary function(Before and three months after nutrition supplementation)
- Changes in exercise capacity(Before and three months after nutrition supplementation)
- Changes in anthropometric indexes(Before and three months after nutrition supplementation)
- Changes in degree of dyspnea(Before and three months after nutrition supplementation)
- Changes in quality of life score(Before and three months after nutrition supplementation)
- Changes in respiratory muscle function(Before and three months after nutrition supplementation)