Clinical trial NCT06949163: Effect of Enteral Formula (Commercial vs. Homemade) on Muscle Mass in Trauma Brain Injury
Official title: Effect of Enteral Polymeric Formulas (Commercial and Homemade Formula) on Muscle Mass in Adults With Trauma Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI Traumatic Brain Injury
Enteral Nutrition Therapy
Critical Illness
Keywords: Trauma brain injury
Enteral nutrition
Critically ill
Muscle Loss
Lead sponsor: Hospital General "Dr. Miguel Silva" de Morelia
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Phase angle
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)
Other outcomes:
Locations:
city: Morelia
country: Mexico
facility: Hospital General "Dr. Miguel Silva"
state: Michoacán
Study officials:
References:
citation: Compher C, Bingham AL, McCall M, Patel J, Rice TW, Braunschweig C, McKeever L. Guidelines for the provision of nutrition support therapy in the adult critically ill patient: The American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2022 Jan;46(1):12-41. doi: 10.1002/jpen.2267. Epub 2022 Jan 3.
citation: Bechtold ML, Brown PM, Escuro A, Grenda B, Johnston T, Kozeniecki M, Limketkai BN, Nelson KK, Powers J, Ronan A, Schober N, Strang BJ, Swartz C, Turner J, Tweel L, Walker R, Epp L, Malone A; ASPEN Enteral Nutrition Committee. When is enteral nutrition indicated? JPEN J Parenter Enteral Nutr. 2022 Sep;46(7):1470-1496. doi: 10.1002/jpen.2364. Epub 2022 Jul 15.
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citation: Epp L, Blackmer A, Church A, Ford I, Grenda B, Larimer C, Lewis-Ayalloore J, Malone A, Pataki L, Rempel G, Washington V; ASPEN Enteral Nutrition Committee. Blenderized tube feedings: Practice recommendations from the American Society for Parenteral and Enteral Nutrition. Nutr Clin Pract. 2023 Dec;38(6):1190-1219. doi: 10.1002/ncp.11055. Epub 2023 Oct 3.
citation: Blenderized Feeding Options - The Sky's the Limit. Epp, L. June 2018, Practical Gastroenterology , pp. 30-39
citation: Voskuil, C., Dudar, M., Zhang, Y., & Carr, J. (2023). Skeletal Muscle Ultrasonography and Muscle Fitness Relationships: Effects of Scanning Plane and Echogenicity Correction. Muscles, 2(2), 109-118. https://doi.org/10.3390/muscles2020010
citation: Fazzini B, Markl T, Costas C, Blobner M, Schaller SJ, Prowle J, Puthucheary Z, Wackerhage H. The rate and assessment of muscle wasting during critical illness: a systematic review and meta-analysis. Crit Care. 2023 Jan 3;27(1):2. doi: 10.1186/s13054-022-04253-0.
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