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

A Randomized, Controlled Clinical Trial on the Effect of Protein Supplement on Lean Body Mass in Patients With Community Acquired Pneumonia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03774953
Acronym
CAPprotein
Enrollment
40
Registered
2018-12-13
Start date
2019-01-15
Completion date
2019-06-30
Last updated
2019-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Keywords

pneumonia, community acquired pneumonia, protein, lean body mass, weight loss, readmission, infection

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.

Interventions

DIETARY_SUPPLEMENTProtein and vitamin supplementation

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

Sponsors

Nordsjaellands Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized to intervention or control arm

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Loss of Lean Body MassChange from Baseline lean body mass until 2 months after dischargedLoss of lean body mass measured by bioimpedance

Secondary

MeasureTime frameDescription
Loss of Body weightChange from Baseline weight until 2 months after dischargedLoss of body weight measured by weight scale
ReadmissionsUp to 6 monthsNumber of readmissions
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 dischargedQuality of life measured by units on a scale
Normal daily living functionChange in physical condition from Baseline until 2 months after dischargedNormal daily living function measured by units on a scale

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026