High Protein and Energy Diet for Better Coughing in COPD Patients
Effects of a Diet High in Protein and Energy in Combination With Physical Activity for the Improvement of Coughing Capacity in COPD Patients
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
April 23, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJune 5, 2019
June 1, 2019
5 months
April 17, 2019
June 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement of coughing capacity of COPD patients
Measured by a validated danish version of Leicester Cough Questionnaire (1-7 points)
8 weeks
Secondary Outcomes (2)
Weight change
8 weeks
Oxygen saturation before and after treatment
8 weeks
Study Arms (2)
Intervention group
EXPERIMENTAL1.3 g protein per kg bodyweight per day for 8 weeks
Kontrol group
ACTIVE COMPARATORhabitual diet
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosed with COPD
- Participating in ongoing lung rehabilitating programme at Hvidovre and Bispebjerg Hospital
- over 18 years
You may not qualify if:
- Plasma creatinin over 200 mikrog/l
- dementia
- unable to read or speak danish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Bispebjerg Hospitalcollaborator
Study Sites (1)
Department of Pulmonary Medicine, Bispebjerg Hospital
Copenhagen, 2400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens R Andersen, MD, MPA
Associate Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 17, 2019
First Posted
April 23, 2019
Study Start
July 1, 2019
Primary Completion
December 1, 2019
Study Completion
July 1, 2020
Last Updated
June 5, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share