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

Not Applicable
Completed
Conditions
Community-acquired Pneumonia
Interventions
Dietary Supplement: Protein and vitamin supplementation
Registration Number
NCT03774953
Lead Sponsor
Nordsjaellands Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention groupProtein and vitamin supplementationprotein and vitamin supplementation
Primary Outcome Measures
NameTimeMethod
Loss of Lean Body MassChange from Baseline lean body mass until 2 months after discharged

Loss of lean body mass measured by bioimpedance

Secondary Outcome Measures
NameTimeMethod
Loss of Body weightChange from Baseline weight until 2 months after discharged

Loss of body weight measured by weight scale

ReadmissionsUp to 6 months

Number of readmissions

Normal daily living functionChange in physical condition from Baseline until 2 months after discharged

Normal daily living function measured by units on a scale

Length of hospital stay between the two groupsFrom admission until discharge (an average of 5 days)

Number of days

Quality of life measured by units on a scaleChange in individual experiences regards to quality of life from Baseline until 2 months after discharged

Quality of life measured by units on a scale

Trial Locations

Locations (1)

Nordsjaellands hospital

🇩🇰

Hillerød, Denmark

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