High Protein and Energy Diet for Better Coughing in COPD Patients

NCT ID: NCT03923764

Last Updated: 2019-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-07-01

Brief Summary

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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

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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

Conditions

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Copd

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

1.3 g protein per kg bodyweight per day for 8 weeks

Group Type EXPERIMENTAL

High protein and energy diet

Intervention Type DIETARY_SUPPLEMENT

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.

Kontrol group

habitual diet

Group Type ACTIVE_COMPARATOR

Habitual Diet

Intervention Type OTHER

Patients continue their usual diet

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Habitual Diet

Patients continue their usual diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Responsible Party

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Jens Rikardt Andersen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens R Andersen, MD, MPA

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Department of Pulmonary Medicine, Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Camilla Kieffer, stud scient

Role: CONTACT

+4523252262

Jens R Andersen, MD, MPA

Role: CONTACT

+4523346654

Other Identifiers

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KOL1

Identifier Type: -

Identifier Source: org_study_id

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