Chronic Obstructive Pulmonary Disease(COPD), Malnutrition
Conditions
Keywords
COPD, malnutrition, nutrition supplementation
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTenteral nutrition emulsion
The patient should drink the oral nutritional supplements according to the estimated energy intake and make a record everyday.The patients will be followed up regularly.
Sponsors
Guangzhou Institute of Respiratory Disease
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in nutritional status | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in anthropometric indexes | Before and three months after nutrition supplementation | Differences in triceps skinfold thickness（TSF）,mid-arm muscle circumference(MAMC), mid-arm circumference(MAC) measured by tape |
| Changes in degree of dyspnea | Before and three months after nutrition supplementation | Difference in dyspnea measured by modified Medical British Research Council（mMRC） |
| Changes in pulmonary function | Before and three months after nutrition supplementation | Differences in forced expiratory volume in first second(FEV1),forced vital capacity(FVC),forced expiratory volume in first second ratio of forced vital capacity(FEV1/FVC) measured by spirometry |
| Changes in respiratory muscle function | Before and three months after nutrition supplementation | Differences in maximal inspiratory pressure（PImax) and maximal expiratory pressure (PEmax) measured by respiratory muscle measurement instrument |
| Changes in quality of life score | Before and three months after nutrition supplementation | Differences in scores measured by Saint George Respiratory Questionaire score |
| Changes in exercise capacity | Before and three months after nutrition supplementation | Difference in walk distance by six minutes walk test(6MWT) |
Countries
China
Contacts
Primary ContactLiqing Wang, doctor
Outcome results
None listed