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The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia (CAPprotein)

Primary Purpose

Community-acquired Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Protein and vitamin supplementation
Sponsored by
Nordsjaellands Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring pneumonia, community acquired pneumonia, protein, lean body mass, weight loss, readmission, infection

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized patients with community acquired pneumonia
  • >60 years
  • Patients who are able to speak and understand Danish

Exclusion Criteria:

  • Patients with hospitalized acquired pneumonia
  • Patients with septic shock
  • Patients with an active cancer and in cancer treatment
  • Patients in dialysis
  • ICU patients
  • Patients unable or unwilling to give informed consent

Sites / Locations

  • Nordsjaellands hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

protein and vitamin supplementation

No supplementations

Outcomes

Primary Outcome Measures

Loss of Lean Body Mass
Loss of lean body mass measured by bioimpedance

Secondary Outcome Measures

Loss of Body weight
Loss of body weight measured by weight scale
Readmissions
Number of readmissions
Length of hospital stay between the two groups
Number of days
Quality of life measured by units on a scale
Quality of life measured by units on a scale
Normal daily living function
Normal daily living function measured by units on a scale

Full Information

First Posted
December 11, 2018
Last Updated
September 12, 2019
Sponsor
Nordsjaellands Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03774953
Brief Title
The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia
Acronym
CAPprotein
Official Title
A Randomized, Controlled Clinical Trial on the Effect of Protein Supplement on Lean Body Mass in Patients With Community Acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordsjaellands Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical trial is to reduce the patient's loss of lean body mass by protein supplementation during hospitalization and 60 days after hospital discharge. Also, the study aims to reduce the risk of readmission to the hospital due to relapse or complications and thereby improving the overall health for the patients. The intervention group will receive protein supplementation during hospitalization and after discharge, while the control group will continue their normal diet.
Detailed Description
Infections are globally the biggest cause of mortality. In Denmark community acquired pneumonia is one of the most common causes for infections in patients. Mortality in pneumonia has been stable high over the past 10 years. Therefore, it is relevant to look at improving the prognosis of these patients. After a longer period of hospitalization, patients generally have a poor condition with loss of body weight and lean body mass. Hereafter, patients must often undergo a longterm rehabilitation period and they become inactive and fatigue. This is a threat for the patients, due to the fact that there is a higher risk of complications and readmissions. Proteins are the body's building blocks. Thus, supplementing patients with a daily higher protein content, it is believed to reduce their loss of lean body mass, and thereby reduce the total loss of body weight as well. Protein supplementation together with vitamin- and mineral supplementation is thought to improve all these health risk markers for the patients. Methods: Inclusion: 40 men and women >60 years hospitalized with community acquired pneumonia Intervention: The patients will be randomized to either the control- or intervention group. They will receive the same treatment and care, the only difference is that the patients in the intervention group will receive protein- and vitamin supplementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
pneumonia, community acquired pneumonia, protein, lean body mass, weight loss, readmission, infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized to intervention or control arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
protein and vitamin supplementation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No supplementations
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein and vitamin supplementation
Intervention Description
The intervention group will receive 1.5 g protein/kilo/day during hospitalization and a standard dose of 27 g protein/day in 60 days after discharged together with a daily dose of vitamin/mineral supplement
Primary Outcome Measure Information:
Title
Loss of Lean Body Mass
Description
Loss of lean body mass measured by bioimpedance
Time Frame
Change from Baseline lean body mass until 2 months after discharged
Secondary Outcome Measure Information:
Title
Loss of Body weight
Description
Loss of body weight measured by weight scale
Time Frame
Change from Baseline weight until 2 months after discharged
Title
Readmissions
Description
Number of readmissions
Time Frame
Up to 6 months
Title
Length of hospital stay between the two groups
Description
Number of days
Time Frame
From admission until discharge (an average of 5 days)
Title
Quality of life measured by units on a scale
Description
Quality of life measured by units on a scale
Time Frame
Change in individual experiences regards to quality of life from Baseline until 2 months after discharged
Title
Normal daily living function
Description
Normal daily living function measured by units on a scale
Time Frame
Change in physical condition from Baseline until 2 months after discharged

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized patients with community acquired pneumonia >60 years Patients who are able to speak and understand Danish Exclusion Criteria: Patients with hospitalized acquired pneumonia Patients with septic shock Patients with an active cancer and in cancer treatment Patients in dialysis ICU patients Patients unable or unwilling to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte Lindegaard Madsen
Organizational Affiliation
Nordsjaellands Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Nordsjaellands hospital
City
Hillerød
Country
Denmark

12. IPD Sharing Statement

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The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia

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