High Protein and Energy Diet for Better Coughing in COPD Patients

June 3, 2019 updated by: Jens Rikardt Andersen, University of Copenhagen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Department of Pulmonary Medicine, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
1.3 g protein per kg bodyweight per day for 8 weeks
Dietary supplement: High protein and energy diet
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.
Active Comparator: Kontrol group
habitual diet
Other: Habitual Diet
Patients continue their usual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of coughing capacity of COPD patients
Time Frame: 8 weeks
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
Time Frame: 8 weeks
kg difference
8 weeks
Oxygen saturation before and after treatment
Time Frame: 8 weeks
Finger tip measurement - % of normal
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Bispebjerg Hospital

Investigators

  • Principal Investigator: Jens R Andersen, MD, MPA, Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOL1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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