High Protein and Energy Diet for Better Coughing in COPD Patients
Primary Purpose
Copd
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High protein and energy diet
Habitual Diet
Sponsored by
About this trial
This is an interventional supportive care trial for Copd
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
Sites / Locations
- Department of Pulmonary Medicine, Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Kontrol group
Arm Description
1.3 g protein per kg bodyweight per day for 8 weeks
habitual diet
Outcomes
Primary Outcome Measures
Improvement of coughing capacity of COPD patients
Measured by a validated danish version of Leicester Cough Questionnaire (1-7 points)
Secondary Outcome Measures
Weight change
kg difference
Oxygen saturation before and after treatment
Finger tip measurement - % of normal
Full Information
NCT ID
NCT03923764
First Posted
April 17, 2019
Last Updated
June 3, 2019
Sponsor
University of Copenhagen
Collaborators
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03923764
Brief Title
High Protein and Energy Diet for Better Coughing in COPD Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
1.3 g protein per kg bodyweight per day for 8 weeks
Arm Title
Kontrol group
Arm Type
Active Comparator
Arm Description
habitual diet
Intervention Type
Dietary Supplement
Intervention Name(s)
High protein and energy diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Habitual Diet
Intervention Description
Patients continue their usual diet
Primary Outcome Measure Information:
Title
Improvement of coughing capacity of COPD patients
Description
Measured by a validated danish version of Leicester Cough Questionnaire (1-7 points)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Weight change
Description
kg difference
Time Frame
8 weeks
Title
Oxygen saturation before and after treatment
Description
Finger tip measurement - % of normal
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Kieffer, stud scient
Phone
+4523252262
Email
camillakieffer@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jens R Andersen, MD, MPA
Phone
+4523346654
Email
jra@nexs.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, MD, MPA
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pulmonary Medicine, Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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High Protein and Energy Diet for Better Coughing in COPD Patients
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