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Recruiting NCT06940284

Food Intake of Hospitalized Elderly and Its Influence on Muscular and Clinical Outcomes

Observational Atrophy, Muscular Undernutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atrophy, Muscular, Undernutrition. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Food Intake of Hospitalized Elderly and Its Influence on Muscular and Clinical Outcomes: A Prospective Cohort Study

Overview

The objectives of the present study are: 1) to characterize the energy-protein intake of the elderly during hospitalization; 2) to verify the influence of energy-protein intake during hospitalization on muscular (i.e., cross-sectional area of the rectus femoris and vastus lateralis muscles, muscle strength, functionality and level of independence) and clinical (i.e., length of hospital stay, hospital readmission and mortality) at the time of hospital discharge, 2 and 6 months after hospital discharge and; 3) to verify whether energy-protein intake during hospitalization is a significant predictor of loss of function and muscle mass, length of hospital stay, hospital readmission rate and mortality.

Primary outcome measures

  • Vastus Lateralis Muscle Cross-sectional Area [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
Secondary outcome measures (6)
  • Handgrip strength [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
  • Muscle function [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
  • Functional independence [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
  • Length of hospital stay [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
  • Mortality [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
  • Hospital readmission post-medical discharge [Time frame: 1- and 2- months post-medical discharge]

Eligibility criteria

Inclusion criteria

  • both sex;
  • 65 years and older;
  • hospital stay less than 48 hours;

Exclusion criteria

  • cancer in the last 5 years;
  • delirium;
  • cognitive deficit that impossibility the patient to read and sign the informed consent form;
  • neurological disease;
  • neurodegenerative muscular disease;
  • patients receive nutrition via enteral and parenteral routes.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Brazil · 1 center
  • University of Sao Paulo — São Paulo

Identifiers

NCT: NCT06940284 · 66834923300000068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗