Impact of nutritional intervention on the nutritional status, oxidative stress and inflammation in patients with chronic obstructive pulmonary disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Outcome Name: Antioxidant capacity, Time-point: once in 4 weeks
研究概览
简要总结
This study is a non-randomized, open blindedquasi experimental nutritional intervention evaluating the effect ofnutritional intervention using a functional food formulation in 40 malnourishedsubjects with COPD for a period of 6 months. The primary outcome measures aretheir nutritional status and related alterations in body composition, lungfunction, blood levels of oxidative stress and inflammatory markers and numberof exacerbations at initiation, during and completion of intervention period. Thesecondary outcome measures are exercise capacity and quality of life at the initiationand end of the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of both genders diagnosed with COPD
- •Age:- between 40-75 years
- •Subjects with BMI < 20 kg/m2 and (or) PGSGA rating of ‘C’ and with deficits in calorie intake of < 75% the recommended dietary intake
- •Patients without a history of or ongoing nutritional therapy.
排除标准
- •1.Patients with acute exacerbation of COPD 2.Patients with heart disease, cirrhosis, uncontrolled diabetes, chronic renal failure and clinically diagnosed infection.
结局指标
主要结局
Outcome Name: Antioxidant capacity, Time-point: once in 4 weeks
时间窗: Once in four weeks for a period of six months
Outcome Name: Nutritional status – Body mass index, body composition, dietary intake Time-points: once in 4 weeks
时间窗: Once in four weeks for a period of six months
Outcome name: Inflammatory markers (C reactive protein, Tumor necrosis factor alpha), Time point: once in 4 weeks
时间窗: Once in four weeks for a period of six months
Outcome name: Pulmonary function, Time point: once in 4 weeks
时间窗: Once in four weeks for a period of six months
次要结局
- Outcome name: BODE Index, Time point : once in 4 weeks(Outcome name: 6 minute walk test : Time point : once in 4 weeks)