High Protein and Energy Diet for Better Coughing in COPD Patients

Not Applicable

• Conditions: Copd

• Registration Number: NCT03923764
• Lead Sponsor: University of Copenhagen

Brief Summary

Chronic Obstructive Lung Disease (COPD) is one of the leading death causes worldwide. COPD is a disease that is characterized by chronic inflammation which leads to irreversible damage of airways and lung tissue. This intervention investigates the effects of a diet high in protein and energy for the improvement of coughing capacity and lung function of COPD patients. The patients will be recruited as part of a lung rehabilitating programme which takes place in Bispebjerg and Hvidovre Hospital. The intervention group receives individual nutritional guidelines whereas the control group continues their usual diet. Blood tests will be performed at baseline and the end of the study. Other anthropometric measures include spirometry for lung function, hand grip strength and fat free mass to assess muscle waisting.

Detailed Description

40 patients with COPD randomized to diet with protein 1.3 g/kg/day or habitual intake:

Primary endpoint (before-after): Leicester Cough Questionnaire Secondary endpoints: ADL-score, no. daily cough periods, development in FEV1 and FVC, hand-grib-strenght, use of respiratory medications, smoking, appetite, admissions to hospital, antibiotics and/or steroids, oxygen saturation, FFM (BIA), Coughs tests in spirometer and peak-flow-meter

Study period: 2 months

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-23
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05
• Study Start: 2019-07-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Diagnosed with COPD
• Participating in ongoing lung rehabilitating programme at Hvidovre and Bispebjerg Hospital
• over 18 years

Exclusion Criteria

• Plasma creatinin over 200 mikrog/l
• dementia
• unable to read or speak danish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of coughing capacity of COPD patients	8 weeks	Measured by a validated danish version of Leicester Cough Questionnaire (1-7 points)

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation before and after treatment	8 weeks	Finger tip measurement - % of normal
Weight change	8 weeks	kg difference

Trial Locations

Locations (1)

Department of Pulmonary Medicine, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark