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NCT Number: NCT06940284

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

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.

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Key information

Conditions

Atrophy, Muscular Atrophy Malnutrition Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Undernutrition

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Vastus Lateralis Muscle Cross-sectional Area

    Time frame: From date of admission until the date of medical discharge. Up to 30 days.

    Vastus Lateralis Muscle Cross-sectional Area will be assessed through ultrasound

Secondary outcomes

  1. Handgrip strength

    Time frame: From date of admission until the date of medical discharge. Up to 30 days.

    Strength will be evaluated using handgrip strength test

  2. Muscle function

    Time frame: From date of admission until the date of medical discharge. Up to 30 days.

    Muscle function evaluated trough battery of test

  3. Functional independence

    Time frame: From date of admission until the date of medical discharge. Up to 30 days.

    Functional independence will be assessed using Barthel Index. The scores range from 0 to 100. A score of 100 means the individual is fully independent, while lower scores indicate increasing levels of dependence.

  4. Length of hospital stay

    Time frame: From date of admission until the date of medical discharge. Up to 30 days.

    Length of hospital stay will be the time (in days) until medical discharge.

  5. Mortality

    Time frame: From date of admission until the date of medical discharge. Up to 30 days.

    Mortality rate in percent

  6. Hospital readmission post-medical discharge

    Time frame: 1- and 2- months post-medical discharge

    Hospital readmission post-medical discharge will be the number of times that he is admitted in the hospital post-medical discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Hamilton Roschel, PhD

CONTACT

[email protected]

+551130618789

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
May 23, 2025

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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