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

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

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.

Study Overview

• Status: Completed
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Dietary supplement: Protein and vitamin supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark
    • Nordsjaellands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; protein and vitamin supplementation	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
NO_INTERVENTION: Control group; No supplementations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss of Body weight	Loss of body weight measured by weight scale	Change from Baseline weight until 2 months after discharged
Readmissions	Number of readmissions	Up to 6 months
Length of hospital stay between the two groups	Number of days	From admission until discharge (an average of 5 days)
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
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

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Study Director: Birgitte Lindegaard Madsen, Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2019
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (ACTUAL): December 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: infection; pneumonia; weight loss; protein; readmission; community acquired pneumonia; lean body mass
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: CAP protein

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No