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Clinical Trials/NCT03923764
NCT03923764UnknownNot Applicable

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

University of Copenhagen1 site in 1 country48 target enrollmentStarted: July 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
48
Locations
1
Primary Endpoint
Improvement of coughing capacity of 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •unable to read or speak danish

Arms & Interventions

Intervention group

Experimental

1.3 g protein per kg bodyweight per day for 8 weeks

Intervention: High protein and energy diet (Dietary Supplement)

Kontrol group

Active Comparator

habitual diet

Intervention: Habitual Diet (Other)

Outcomes

Primary Outcomes

Improvement of coughing capacity of COPD patients

Time Frame: 8 weeks

Measured by a validated danish version of Leicester Cough Questionnaire (1-7 points)

Secondary Outcomes

  • Weight change(8 weeks)
  • Oxygen saturation before and after treatment(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jens Rikardt Andersen

Associate Professor

University of Copenhagen

Study Sites (1)

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