Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD:a Randomised Controlled Trial

Conditions
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Chronic Obstructive Pulmonary Disease(COPD), Malnutrition

Intervention / Treatment
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* Dietary Supplement: enteral nutrition emulsion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: blank control<br>usual diet | |
| Experimental: nutrition supplementation<br>In addition to usual diet,the patients will be given enteral nutrition emulsion, which is a oral nutrition liquid composed of proteins,omega-3 fatty acids,carbohydrate,vitamins.Every package contains 200ml and provides 260 kcal energy. | Dietary Supplement: enteral nutrition emulsion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nutritional status | 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. | Before and three months after nutrition supplementation | 
| Changes in the serum levels of inflammatory markers | Changes in the serum levels of tumor necrosis factor-α(TNF-α)、interleukin-6（IL-6）、C-reactive protein(CRP) by laboratory technology. | Before and three months after nutrition supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pulmonary function | 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 | Before and three months after nutrition supplementation | 
| Changes in exercise capacity | Difference in walk distance by six minutes walk test(6MWT) | Before and three months after nutrition supplementation | 
| Changes in anthropometric indexes | Differences in triceps skinfold thickness（TSF）,mid-arm muscle circumference(MAMC), mid-arm circumference(MAC) measured by tape | Before and three months after nutrition supplementation | 
| Changes in degree of dyspnea | Difference in dyspnea measured by modified Medical British Research Council（mMRC） | Before and three months after nutrition supplementation | 
| Changes in quality of life score | Differences in scores measured by Saint George Respiratory Questionaire score | Before and three months after nutrition supplementation | 
| Changes in respiratory muscle function | Differences in maximal inspiratory pressure（PImax) and maximal expiratory pressure (PEmax) measured by respiratory muscle measurement instrument | Before and three months after nutrition supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, malnutrition, nutrition supplementation