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

NCT06940284 | Recruiting

• 1 other identifier: 66834923300000068
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrophy, Muscular; Undernutrition

Outcome Measures

Primary Outcomes (1)

• Vastus Lateralis Muscle Cross-sectional Area

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

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

Secondary Outcomes (6)

• Handgrip strength

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

• Muscle function

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

• Functional independence

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

• Length of hospital stay

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

• Mortality

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

Study Arms (1)

Older individuals hospitalized

Older adults admitted to the hospital within the past 48 hours, without signs of delirium, and able to receive oral nutrition and complete muscle function assessments.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Older individuals hospitalized

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-030, Brazil

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy; Malnutrition

Condition Hierarchy (Ancestors)

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

Study Officials

• Hamilton Roschel, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamilton Roschel, PhD

CONTACT

+551130618789; hars@usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 23, 2025
• Study Start: May 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)