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Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease(COPD), Malnutrition

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

enteral nutrition emulsion

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease(COPD) focused on measuring COPD, malnutrition, nutrition supplementation

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhujiang Hospital,Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

blank control

nutrition supplementation

Arm Description

usual diet

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

Changes in exercise capacity

Difference in walk distance by six minutes walk test(6MWT)

Changes in anthropometric indexes

Differences in triceps skinfold thickness（TSF）,mid-arm muscle circumference(MAMC), mid-arm circumference(MAC) measured by tape

Changes in degree of dyspnea

Difference in dyspnea measured by modified Medical British Research Council（mMRC）

Changes in quality of life score

Differences in scores measured by Saint George Respiratory Questionaire score

Changes in respiratory muscle function

Differences in maximal inspiratory pressure（PImax) and maximal expiratory pressure (PEmax) measured by respiratory muscle measurement instrument

Full Information

NCT ID

NCT02197871

First Posted

July 21, 2014

Last Updated

July 21, 2014

Sponsor

Zhujiang Hospital

Collaborators

Guangzhou Institute of Respiratory Disease

1. Study Identification

Unique Protocol Identification Number

NCT02197871

Brief Title

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

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhujiang Hospital

Collaborators

Guangzhou Institute of Respiratory Disease

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease(COPD), Malnutrition

Keywords

COPD, malnutrition, nutrition supplementation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

blank control

Arm Type

No Intervention

Arm Description

usual diet

Arm Title

nutrition supplementation

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

enteral nutrition emulsion

Intervention Description

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 Measure Information:

Title

Changes in nutritional status

Description

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.

Time Frame

Before and three months after nutrition supplementation

Title

Changes in the serum levels of inflammatory markers

Description

Changes in the serum levels of tumor necrosis factor-α(TNF-α)、interleukin-6（IL-6）、C-reactive protein(CRP) by laboratory technology.

Time Frame

Before and three months after nutrition supplementation

Secondary Outcome Measure Information:

Title

Changes in pulmonary function

Description

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

Time Frame

Before and three months after nutrition supplementation

Title

Changes in exercise capacity

Description

Difference in walk distance by six minutes walk test(6MWT)

Time Frame

Before and three months after nutrition supplementation

Title

Changes in anthropometric indexes

Description

Differences in triceps skinfold thickness（TSF）,mid-arm muscle circumference(MAMC), mid-arm circumference(MAC) measured by tape

Time Frame

Before and three months after nutrition supplementation

Title

Changes in degree of dyspnea

Description

Difference in dyspnea measured by modified Medical British Research Council（mMRC）

Time Frame

Before and three months after nutrition supplementation

Title

Changes in quality of life score

Description

Differences in scores measured by Saint George Respiratory Questionaire score

Time Frame

Before and three months after nutrition supplementation

Title

Changes in respiratory muscle function

Description

Differences in maximal inspiratory pressure（PImax) and maximal expiratory pressure (PEmax) measured by respiratory muscle measurement instrument

Time Frame

Before and three months after nutrition supplementation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liqing Wang, doctor

Phone

+86-02062783391

wliqing07@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xin Chen, doctor

Organizational Affiliation

Zhujiang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhujiang Hospital,Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510282

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liqing Wang, doctor

Phone

+86-02062783391

wliqing07@gmail.com

12. IPD Sharing Statement

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Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD

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