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Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD

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ClinicalTrials.gov Identifier: NCT02197871
Recruitment Status : Unknown
Verified July 2014 by Zhujiang Hospital.
Recruitment status was:  Recruiting
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
Guangzhou Institute of Respiratory Disease
Information provided by (Responsible Party):
Zhujiang Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease(COPD) Malnutrition Dietary Supplement: enteral nutrition emulsion Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD:a Randomised Controlled Trial
Study Start Date : July 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: blank control
usual diet
Experimental: nutrition supplementation
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
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.




Primary Outcome Measures :
  1. Changes in nutritional status [ Time Frame: 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.

  2. Changes in the serum levels of inflammatory markers [ Time Frame: 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 Outcome Measures :
  1. Changes in pulmonary function [ Time Frame: 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

  2. Changes in exercise capacity [ Time Frame: Before and three months after nutrition supplementation ]
    Difference in walk distance by six minutes walk test(6MWT)

  3. Changes in anthropometric indexes [ Time Frame: 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

  4. Changes in degree of dyspnea [ Time Frame: Before and three months after nutrition supplementation ]
    Difference in dyspnea measured by modified Medical British Research Council(mMRC)

  5. Changes in quality of life score [ Time Frame: Before and three months after nutrition supplementation ]
    Differences in scores measured by Saint George Respiratory Questionaire score

  6. Changes in respiratory muscle function [ Time Frame: Before and three months after nutrition supplementation ]
    Differences in maximal inspiratory pressure(PImax) and maximal expiratory pressure (PEmax) measured by respiratory muscle measurement instrument



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197871


Contacts
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Contact: Liqing Wang, doctor +86-02062783391 wliqing07@gmail.com

Locations
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China, Guangdong
Zhujiang Hospital,Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Liqing Wang, doctor    +86-02062783391    wliqing07@gmail.com   
Sponsors and Collaborators
Zhujiang Hospital
Guangzhou Institute of Respiratory Disease
Investigators
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Principal Investigator: Xin Chen, doctor Zhujiang Hospital

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Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT02197871     History of Changes
Other Study ID Numbers: CX20140718
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014
Keywords provided by Zhujiang Hospital:
COPD
malnutrition
nutrition supplementation
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Malnutrition
Lung Diseases
Respiratory Tract Diseases
Nutrition Disorders