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

Hospital General "Dr. Miguel Silva" de Morelia

Status: Completed

Conditions: Critical Illness; Enteral Nutrition Therapy; TBI Traumatic Brain Injury

Treatments: Dietary Supplement: Commercial formula; Other: Homemade formula

Study type: Interventional

Funder types: Other

Identifiers

NCT06949163

666/02/23

Details and patient eligibility

About

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).

Full 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).

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups

Homemade formula

Other group

Description:

Patients receiving homemade formula made with natural food and will be administered according to the study protocol

Treatment:

Other: Homemade formula

Commercial enteral formula

Other group

Description:

Patients receiving commercial formula and will be administered according to the study protocol.

Treatment:

Dietary Supplement: Commercial formula