NCT06949163

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Hospital General "Dr. Miguel Silva" de Morelia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

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).

Conditions

• TBI Traumatic Brain Injury
• Enteral Nutrition Therapy
• Critical Illness

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2023-06-26
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2025-04-29
• Last updated: 2025-05-01

Locations

1 site across 1 country: Mexico