High Protein and Energy Diet for Better Coughing in COPD Patients

Study Overview
=================
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

Official Title
-----------------
Effects of a Diet High in Protein and Energy in Combination With Physical Activity for the Improvement of Coughing Capacity in COPD Patients

Conditions
-----------------
Copd

Intervention / Treatment
-----------------
* Dietary Supplement: High protein and energy diet
* Other: Habitual Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>1.3 g protein per kg bodyweight per day for 8 weeks | Dietary Supplement: High protein and energy diet<br>* Intervention group receives nutritional counseling to increase protein and energy in their diet to reach their estimated protein need (1.3 g/kg). Kontrol group continues their usual diet.<br>|
| Active Comparator: Kontrol group<br>habitual diet | Other: Habitual Diet<br>* Patients continue their usual diet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of coughing capacity of COPD patients | Measured by a validated danish version of Leicester Cough Questionnaire (1-7 points) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | kg difference | 8 weeks | 
| Oxygen saturation before and after treatment | Finger tip measurement - % of normal | 8 weeks |