Clinical trial NCT02197871: Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD
Official title: Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD:a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease(COPD)
Malnutrition
Keywords: COPD
malnutrition
nutrition supplementation
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Institute of Respiratory Disease
First posted: 2014-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in nutritional status
timeFrame: Before and three months after nutrition supplementation
measure: Changes in the serum levels of inflammatory markers
timeFrame: Before and three months after nutrition supplementation
Secondary outcomes:
measure: Changes in pulmonary function
timeFrame: Before and three months after nutrition supplementation
measure: Changes in exercise capacity
timeFrame: Before and three months after nutrition supplementation
measure: Changes in anthropometric indexes
timeFrame: Before and three months after nutrition supplementation
measure: Changes in degree of dyspnea
timeFrame: Before and three months after nutrition supplementation
measure: Changes in quality of life score
timeFrame: Before and three months after nutrition supplementation
measure: Changes in respiratory muscle function
timeFrame: Before and three months after nutrition supplementation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital,Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Xin Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: