Atrophy, MuscularNCT06940284
Food Intake of Hospitalized Elderly and Its Influence on Muscular and Clinical Outcomes
An observational study of Atrophy, Muscular and Undernutrition, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrophy, Muscular, Undernutrition
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2025to 30 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older individuals hospitalized
Who may be able to join
- both sex;
- 65 years and older;
- hospital stay less than 48 hours;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, São Paulo, 05508-030
Hamilton Roschel, PhD, +55 11 3061-8789, hars@usp.br
About this study
Official title: Food Intake of Hospitalized Elderly and Its Influence on Muscular and Clinical Outcomes: A Prospective Cohort Study
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
- Medical subject headings
- Muscular Atrophy, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vastus Lateralis Muscle Cross-sectional Area
Vastus Lateralis Muscle Cross-sectional Area will be assessed through ultrasound
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Secondary outcomes (6)
Handgrip strength
Strength will be evaluated using handgrip strength test
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Muscle function
Muscle function evaluated trough battery of test
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Functional independence
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.
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Length of hospital stay
Length of hospital stay will be the time (in days) until medical discharge.
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Mortality
Mortality rate in percent
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Hospital readmission post-medical discharge
Hospital readmission post-medical discharge will be the number of times that he is admitted in the hospital post-medical discharge.
Measured: 1- and 2- months post-medical discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 May 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy, MuscularStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamilton Augusto Roschel da Silva, University of Sao Paulo General Hospital
- Investigators
- Hamilton Roschel, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940284
- Sponsor's protocol ID
- 66834923300000068
- Status last verified
- May 2025
- First submitted
- 14 Apr 2025
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Intake of Hospitalized Elderly and Its Influence on Muscular and Clinical Outcomes: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06940284
- Acronym / sponsor ID
- 66834923300000068
- Conditions
- Atrophy, Muscular, Undernutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older individuals hospitalized
Key inclusion criteria (3 listed)
- both sex;
- 65 years and older;
- hospital stay less than 48 hours;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamilton Roschel, PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrophy, Muscular and Undernutrition, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamilton Roschel, PhD (+551130618789, hars@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vastus Lateralis Muscle Cross-sectional Area (time frame: From date of admission until the date of medical discharge. Up to 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.