CompletedNot Applicable

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

Mexico39 participantsStarted 2023-06-26

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Femoral muscle (total femoral thickness, rectus femoris vastus intermedius) ultrasound

Timeframe: Change from baseline to end of study, an average of 10 days, with three measurements during follow-up (baseline, 5 days, and 10 days)

Trial details

NCT IDNCT06949163

SponsorHospital General "Dr. Miguel Silva" de Morelia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

View on ClinicalTrials.gov More TBI Traumatic Brain Injury trials