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Completed

NCT Number: NCT03774953

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

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Key information

Conditions

Community-Acquired Pneumonia Body Weight Body Weight Changes Community-Acquired Infections Infections Lung Diseases Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Weight Loss

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordsjaellands hospital

Hillerød, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein and vitamin supplementation

Dietary Supplement

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

Primary outcomes

  1. Loss of Lean Body Mass

    Time frame: Change from Baseline lean body mass until 2 months after discharged

    Loss of lean body mass measured by bioimpedance

Secondary outcomes

  1. Loss of Body weight

    Time frame: Change from Baseline weight until 2 months after discharged

    Loss of body weight measured by weight scale

  2. Readmissions

    Time frame: Up to 6 months

    Number of readmissions

  3. Length of hospital stay between the two groups

    Time frame: From admission until discharge (an average of 5 days)

    Number of days

  4. Quality of life measured by units on a scale

    Time frame: Change in individual experiences regards to quality of life from Baseline until 2 months after discharged

    Quality of life measured by units on a scale

  5. Normal daily living function

    Time frame: Change in physical condition from Baseline until 2 months after discharged

    Normal daily living function measured by units on a scale

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Official study title

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

Acronym: CAPprotein

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2018
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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