Effect of Enteral Formula (Commercial vs. Homemade) on Muscle Mass in Trauma Brain Injury

April 28, 2025 updated by: KARINA AGUILAR GUTIERREZ, Hospital General "Dr. Miguel Silva" de Morelia

Effect of Enteral Polymeric Formulas (Commercial and Homemade Formula) on Muscle Mass in Adults With Trauma Brain Injury

This randomized controlled clinical trial aims to determine whether there are differences in muscle mass (MM) in patients with traumatic brain injury who receive enteral nutrition based on polymeric formulas (homemade formula with blended natural foods versus commercial formulas).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients admitted to the intensive care unit (ICU) with traumatic brain injury (TBI) lose MM, especially during the first ten days because it's used for organic, immune and tissue repair functions; the patients with moderate or severe TBI are frequently unable to eat food by themselves, so they receive enteral nutrition support (NS) with polymeric formulas. This support has been shown to attenuate muscle loss. Polymeric formulas can be industrially formulated or made with natural food, but there is no information available on their effect on MM using indicators such as femoral muscle thickness (femoral thickness, rectus femoris and vastus intermedius) by ultrasound (US) and phase angle (PhA) obtained by bioimpedance (BIA), as well as gastrointestinal tolerance (GIT).

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Michoacán
      • Morelia, Michoacán, Mexico, 58253
        • Hospital General "Dr. Miguel Silva"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: ≥ 18 years - 65 years
  • Sex: Both sexes
  • Moderate/severe TBI (Glasgow <13 points) admitted to the ICU
  • Invasive mechanical ventilation >48 hours
  • Candidates for enteral nutrition via nasogastric/orogastric tube

Exclusion Criteria:

  • Pregnant women
  • Patients with pacemakers
  • Food allergies: egg, chicken, fish, nuts, or lactose intolerance
  • Brain death
  • Limb amputation or presence of external limb fixators

Elimination criteria:

  • Withdrawal of consent
  • Transfer to another healthcare institution.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Homemade formula
Patients receiving homemade formula made with natural food and will be administered according to the study protocol
Other: Homemade formula
Patients will receive enteral feeding with a polymeric formula made from blended natural foods (apple, chayote, cookie, chicken and olive oil), adjusted to meet their nutritional requirements (energy: 25 kcal/kg, protein: 1.3 g/kg).
Other Names:
  • blenderized tube feeding
Other: Commercial enteral formula
Patients receiving commercial formula and will be administered according to the study protocol.
Dietary supplement: Commercial formula
Patients will receive enteral feeding with a commercial polymeric formula, adjusted to meet their nutritional requirements (energy: 25 kcal/kg, protein: 1.3 g/kg).
Other Names:
  • polymeric formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Femoral muscle (total femoral thickness, rectus femoris vastus intermedius) ultrasound
Time Frame: Change from baseline to end of study, an average of 10 days, with three measurements during follow-up (baseline, 5 days, and 10 days)
Ultrasound-guided assessment of femoral muscle thickness. A certified intensivist physician accredited by the World Interactive Network Focused On Critical UltraSound, will perform duplicate measurements of muscle thicknesses (total femoral thickness, rectus femoris, and vastus intermedius) at the midpoint and one-third point of the distance between the superior border of the patella and the anterior superior iliac spine. The linear transducer will be positioned at a 90° angle to the thigh, without applying pressure (no compression). The average of the four measurements will then be calculated.
Change from baseline to end of study, an average of 10 days, with three measurements during follow-up (baseline, 5 days, and 10 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase angle
Time Frame: Change from baseline to end of study, an average of 10 days, with three measurements during follow-up (baseline, 5 days, and 10 days)
PhA was assessed using a multifrequency BIA analyzer with 8 limb electrodes, two electrodes per limb. Measurements were taken either two hours before or two hours after the formula infusion.
Change from baseline to end of study, an average of 10 days, with three measurements during follow-up (baseline, 5 days, and 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General "Dr. Miguel Silva" de Morelia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2023

Primary Completion (Actual)

March 30, 2025

Study Completion (Actual)

March 30, 2025

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 666/02/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No, individual participant data (IPD) will not be shared with other researchers.

The data collected are part of a small-scale, single-center study involving vulnerable patients in critical care. Due to concerns about patient confidentiality, limited sample size, and the absence of prior consent for data sharing beyond the original study scope, we have decided not to make IPD publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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