Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD

NCT02197871 | Unknown Phase 4 DMC

• 1 other identifier: CX20140718
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease(COPD); Malnutrition

Keywords

COPD; malnutrition; nutrition supplementation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Changes in pulmonary function

  Before and three months after nutrition supplementation

• Changes in exercise capacity

  Before and three months after nutrition supplementation

• Changes in anthropometric indexes

  Before and three months after nutrition supplementation

• Changes in degree of dyspnea

  Before and three months after nutrition supplementation

• Changes in quality of life score

  Before and three months after nutrition supplementation

Study Arms (2)

blank control

NO INTERVENTION

usual diet

nutrition supplementation

EXPERIMENTAL

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

Interventions

enteral nutrition emulsion DIETARY_SUPPLEMENT

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.

nutrition supplementation

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Guangzhou Institute of Respiratory Disease: collaborator

Study Sites (1)

Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Malnutrition

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Xin Chen, doctor

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liqing Wang, doctor

CONTACT

+86-02062783391; wliqing07@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

CN (1)