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Completed

NCT Number: NCT06949163

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

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Key information

Conditions

TBI Traumatic Brain Injury Atrophy Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Critical Illness Disease Attributes Enteral Nutrition Therapy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General "Dr. Miguel Silva"

Morelia, Michoacán, 58253, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Homemade formula

Other

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

Commercial formula

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital General "Dr. Miguel Silva" de Morelia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
May 1, 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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