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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease(COPD) Malnutrition||Dietary Supplement: enteral nutrition emulsion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: blank control
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.
- 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.
- 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.
- 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
- Changes in exercise capacity [ Time Frame: Before and three months after nutrition supplementation ]Difference in walk distance by six minutes walk test(6MWT)
- 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
- 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）
- 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
- 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
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
|Contact: Liqing Wang, email@example.com|
|Zhujiang Hospital,Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510282|
|Contact: Liqing Wang, doctor +86-02062783391 firstname.lastname@example.org|
|Principal Investigator:||Xin Chen, doctor||Zhujiang Hospital|