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

Community-acquired Pneumonia Clinical Trial

— CAPprotein  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774953
• Other study ID #: CAP protein
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Dietary Supplement:
• Protein 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

Locations

Country	Name	City	State
Denmark	Nordsjaellands hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of Lean Body Mass	Loss of lean body mass measured by bioimpedance	Change from Baseline lean body mass until 2 months after discharged
Secondary	Loss of Body weight	Loss of body weight measured by weight scale	Change from Baseline weight until 2 months after discharged
Secondary	Readmissions	Number of readmissions	Up to 6 months
Secondary	Length of hospital stay between the two groups	Number of days	From admission until discharge (an average of 5 days)
Secondary	Quality of life measured by units on a scale	Quality of life measured by units on a scale	Change in individual experiences regards to quality of life from Baseline until 2 months after discharged
Secondary	Normal daily living function	Normal daily living function measured by units on a scale	Change in physical condition from Baseline until 2 months after discharged