Chronic Obstructive Pulmonary Disease(COPD)Phase 4NCT02197871
Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD
A Phase 4 study testing enteral nutrition emulsion in people with Chronic Obstructive Pulmonary Disease(COPD) and Malnutrition, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease(COPD), Malnutrition
- What is being tested?
- enteral nutrition emulsion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, 510282
Liqing Wang, doctor, +86-02062783391, wliqing07@gmail.com
About this study
Official title: Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD:a Randomised Controlled Trial
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.
Read the 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.
- Being tested
- enteral nutrition emulsion
- Keywords
- COPD, malnutrition, nutrition supplementation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutrition emulsionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: enteral nutrition emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and three months after nutrition supplementation
Secondary outcomes (6)
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
Measured: Before and three months after nutrition supplementation
Changes in exercise capacity
Difference in walk distance by six minutes walk test(6MWT)
Measured: Before and three months after nutrition supplementation
Changes in anthropometric indexes
Differences in triceps skinfold thickness（TSF）,mid-arm muscle circumference(MAMC), mid-arm circumference(MAC) measured by tape
Measured: Before and three months after nutrition supplementation
Changes in degree of dyspnea
Difference in dyspnea measured by modified Medical British Research Council（mMRC）
Measured: Before and three months after nutrition supplementation
Changes in quality of life score
Differences in scores measured by Saint George Respiratory Questionaire score
Measured: Before and three months after nutrition supplementation
Changes in respiratory muscle function
Differences in maximal inspiratory pressure（PImax) and maximal expiratory pressure (PEmax) measured by respiratory muscle measurement instrument
Measured: Before and three months after nutrition supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease(COPD)Studies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Institute of Respiratory Disease
- Responsible party
- Sponsor
- Investigators
- Xin Chen, doctor, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197871
- Sponsor's protocol ID
- CX20140718
- Status last verified
- Jul 2014
- First submitted
- 21 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD:a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02197871
- Acronym / sponsor ID
- CX20140718
- Keywords
- COPD, malnutrition, nutrition supplementation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Institute of Respiratory Disease
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blank control | No intervention | –usual diet |
| nutrition supplementation | Experimental | Dietary Supplement: enteral nutrition emulsionIn 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral nutrition emulsionThe 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. | Dietary supplement | nutrition supplementation |
Primary outcome
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.
6 secondary outcomes
Changes in pulmonary function
Time frame: Before and three months after nutrition supplementation
Changes in exercise capacity
Time frame: Before and three months after nutrition supplementation
Changes in anthropometric indexes
Time frame: Before and three months after nutrition supplementation
Changes in degree of dyspnea
Time frame: Before and three months after nutrition supplementation
Changes in quality of life score
Time frame: Before and three months after nutrition supplementation
Changes in respiratory muscle function
Time frame: Before and three months after nutrition supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Chen, doctor principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing enteral nutrition emulsion in people with Chronic Obstructive Pulmonary Disease(COPD) and Malnutrition, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liqing Wang, doctor (+86-02062783391, wliqing07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in nutritional status (time frame: Before and three months after nutrition supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.