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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Dietary Supplement: Protein and vitamin supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized to intervention or control arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>protein and vitamin supplementation | Dietary Supplement: Protein and vitamin supplementation<br>* 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<br>|
| No Intervention: Control group<br>No supplementations | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, community acquired pneumonia, protein, lean body mass, weight loss, readmission, infection