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

NCT03774953 | Completed

• 1 other identifier: CAP protein
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-acquired Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Loss of Body weight

  Change from Baseline weight until 2 months after discharged

• Readmissions

  Up to 6 months

• Length of hospital stay between the two groups

  From admission until discharge (an average of 5 days)

• 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

  Change in physical condition from Baseline until 2 months after discharged

Study Arms (2)

Intervention group

EXPERIMENTAL

protein and vitamin supplementation

Dietary Supplement: Protein and vitamin supplementation

Control group

NO INTERVENTION

No supplementations

Interventions

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

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients with community acquired pneumonia
• \>60 years
• Patients who are able to speak and understand Danish

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjaellands hospital

Hillerød, Denmark

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia; Weight Loss; Infections

Interventions

Proteins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Birgitte Lindegaard Madsen

  Nordsjaellands Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized to intervention or control arm

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: January 15, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-08

Locations

DK (1)