Clinical trial NCT03774953: The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia
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
Overall status: COMPLETED
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: pneumonia
community acquired pneumonia
protein
lean body mass
weight loss
readmission
infection
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to intervention or control arm
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Loss of Lean Body Mass
timeFrame: Change from Baseline lean body mass until 2 months after discharged
Secondary outcomes:
measure: Loss of Body weight
timeFrame: Change from Baseline weight until 2 months after discharged
measure: Readmissions
timeFrame: Up to 6 months
measure: Length of hospital stay between the two groups
timeFrame: From admission until discharge (an average of 5 days)
measure: Quality of life measured by units on a scale
timeFrame: Change in individual experiences regards to quality of life from Baseline until 2 months after discharged
measure: Normal daily living function
timeFrame: Change in physical condition from Baseline until 2 months after discharged
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjaellands hospital
Study officials:
affiliation: Nordsjaellands Hospital
name: Birgitte Lindegaard Madsen
role: STUDY_DIRECTOR
References: