Impact of Nutritional Support With an Complete Formula on Nutritional Status and Respiratory Function in Adult Patients Malnourished or at Risk of Malnutrition and Chronic Respiratory Disease..
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Changes in nutritional status
研究概览
简要总结
The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard hospital dietary advise.
详细描述
This is a unicenter, controlled, randomized, prospective, parallel-group, open-label study to evaluate the effect of a nutritional formula on nutritional status, pulmonary function and quality of life. Adult patients will be randomized to receive the nutritional formula or to follow the standard hospital' dietetic recommendations during 12 weeks.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years.
- •Patient from Clínica San Gabriel or Clínica San Pablo Surco, inpatient or outpatient.
- •Patients with chronic pulmonary disease (including bronchiectasis, tuberculosis specific sequel, fibrothorax, diffuse interstitial lung disease, COPD).
- •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 moth; FFMI <15 kg/m2 (women) or <16 kg/m2 (men).
- •Patients who signed informed consent.
排除标准
- •Clinically unstable patients.
- •Patients requiring other nutritional supplements or parenteral nutrition.
- •Patients diagnosed with active pulmonary tuberculosis.
- •Patients with acute respiratory failure.
- •Patients with immunosuppression (including HIV, diabetes or neoplasms).
研究组 & 干预措施
Vitafos
Complete enteral formula
干预措施: Complete enteral formula (Dietary Supplement)
Dietary Advise
Dietary advise according to the hospital routine clinical practice.
干预措施: Dietary Advise (Other)
结局指标
主要结局
Changes in nutritional status
时间窗: At hospital discharge or at 1th month and at 3 months
Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures.
Changes in pulmonary function
时间窗: At 3rd month
Differences in forced expiratory volume measured by spirometry.
次要结局
- Respiratory Infections(At 1st, 2nd, 3rd month)
- Muscular Strength(At 3rd month.)
- Exercise Tolerance(At 3th month)
- Quality of Life of the participants(At hospital discharge or 1st month and 3rd month)
- Tolerability of the product(At 1st, 2nd and 3rd months)