High Protein and Energy Diet for Better Coughing in COPD Patients

Copd Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03923764
• Other study ID #: KOL1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: June 2019
• Source: University of Copenhagen
• Contact: Camilla Kieffer, stud scient
• Phone: +4523252262
• Email: camillakieffer[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: July 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Copd

Intervention

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.

Other:
• Habitual Diet
Patients continue their usual diet

Locations

Country	Name	City	State
Denmark	Department of Pulmonary Medicine, Bispebjerg Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of coughing capacity of COPD patients	Measured by a validated danish version of Leicester Cough Questionnaire (1-7 points)	8 weeks
Secondary	Weight change	kg difference	8 weeks
Secondary	Oxygen saturation before and after treatment	Finger tip measurement - % of normal	8 weeks