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

NCT06949163 | Completed DMC

• 1 other identifier: 666/02/23
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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).

Conditions

TBI Traumatic Brain Injury; Enteral Nutrition Therapy; Critical Illness

Keywords

Trauma brain injury; Enteral nutrition; Critically ill; Muscle Loss

Outcome Measures

Primary Outcomes (1)

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

  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.

  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 (1)

• Phase angle

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

Study Arms (2)

Homemade formula

OTHER

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

Other: Homemade formula

Commercial enteral formula

OTHER

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

Dietary Supplement: Commercial formula

Interventions

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).

Also known as: blenderized tube feeding

Homemade formula

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).

Also known as: polymeric formula

Commercial enteral formula

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General "Dr. Miguel Silva" de Morelia: lead

Study Sites (1)

Hospital General "Dr. Miguel Silva"

Morelia, Michoacán, 58253, Mexico

Location

Related Publications (11)

• 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.

  PMID: 34784064 BACKGROUND

• 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.

  PMID: 35838308 BACKGROUND

• Katari Y, Srinivasan R, Arvind P, Hiremathada S. Point-of-Care Ultrasound to Evaluate Thickness of Rectus Femoris, Vastus Intermedius Muscle, and Fat as an Indicator of Muscle and Fat Wasting in Critically Ill Patients in a Multidisciplinary Intensive Care Unit. Indian J Crit Care Med. 2018 Nov;22(11):781-788. doi: 10.4103/ijccm.IJCCM_394_18.

  PMID: 30598564 BACKGROUND

• Nascimento TS, de Queiroz RS, Ramos ACC, Martinez BP, Da Silva E Silva CM, Gomes-Neto M. Ultrasound Protocols to Assess Skeletal and Diaphragmatic Muscle in People Who Are Critically Ill: A Systematic Review. Ultrasound Med Biol. 2021 Nov;47(11):3041-3067. doi: 10.1016/j.ultrasmedbio.2021.06.017. Epub 2021 Aug 18.

  PMID: 34417065 BACKGROUND

• 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.

  PMID: 37787762 BACKGROUND

• Blenderized Feeding Options - The Sky's the Limit. Epp, L. June 2018, Practical Gastroenterology , pp. 30-39

  BACKGROUND

• Voskuil C, Dudar M, Zhang Y, Carr J. Skeletal Muscle Ultrasonography and Muscle Fitness Relationships: Effects of Scanning Plane and Echogenicity Correction. Muscles. 2023 Mar 23;2(2):109-118. doi: 10.3390/muscles2020010.

  PMID: 40757563 BACKGROUND

• 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.

  PMID: 36597123 BACKGROUND

• Kalra S, Malik R, Singh G, Bhatia S, Al-Harrasi A, Mohan S, Albratty M, Albarrati A, Tambuwala MM. Pathogenesis and management of traumatic brain injury (TBI): role of neuroinflammation and anti-inflammatory drugs. Inflammopharmacology. 2022 Aug;30(4):1153-1166. doi: 10.1007/s10787-022-01017-8. Epub 2022 Jul 8.

  PMID: 35802283 BACKGROUND

• Khellaf A, Khan DZ, Helmy A. Recent advances in traumatic brain injury. J Neurol. 2019 Nov;266(11):2878-2889. doi: 10.1007/s00415-019-09541-4. Epub 2019 Sep 28.

  PMID: 31563989 BACKGROUND

• Bailes JE, Borlongan CV. Traumatic brain injury. CNS Neurosci Ther. 2020 Jun;26(6):593-594. doi: 10.1111/cns.13397. No abstract available.

  PMID: 32452140 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Critical Illness; Muscular Atrophy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the patient and the principal investigator will be blinded to the assigned formula. A hospital nutritionist will be responsible for the prescription and progression according to the proposed requirements and the tolerance of the assigned formula.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Karina Aguilar Gutiérrez

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: June 26, 2023
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)