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TBI Traumatic Brain InjuryNCT06949163

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

A study testing Homemade formula and Commercial formula in people with TBI Traumatic Brain Injury and Enteral Nutrition Therapy, run by Hospital General "Dr. Miguel Silva" de Morelia at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Homemade formula and Commercial formula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteMexico
Study dates
26 Jun 2023to 30 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital General "Dr. Miguel Silva"

    Morelia, Michoacán, 58253

Other trials in Mexico

About this study

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

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).

Read the 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).

Being tested
Homemade formula, Commercial formula
Keywords
Trauma brain injury, Enteral nutrition, Critically ill, Muscle Loss
Medical subject headings
Brain Injuries, Traumatic, Critical Illness, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Homemade formulaOther

    Also called blenderized tube feeding

    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).

  • Commercial formulaDietary supplement

    Also called polymeric 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).

Study groups in NCT06949163
Study groupRoleWhat they receive
Homemade formulaOtherPatients receiving homemade formula made with natural food and will be administered according to the study protocol
Receives: Other: Homemade formula
Commercial enteral formulaOtherPatients receiving commercial formula and will be administered according to the study protocol.
Receives: Dietary Supplement: Commercial formula

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Phase angle

    PhA was assessed using a multifrequency BIA analyzer with 8 limb electrodes, two electrodes per limb. Measurements were taken either two hours before or two hours after the formula infusion.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start26 Jun 2023
  3. Primary completion30 Mar 2025
  4. Study completion30 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06949163
Sponsor's protocol ID
666/02/23
Status last verified
Apr 2025
First submitted
22 Apr 2025
Last updated
1 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No, individual participant data (IPD) will not be shared with other researchers. The data collected are part of a small-scale, single-center study involving vulnerable patients in critical care. Due to concerns about patient confidentiality, limited sample size, and the absence of prior consent for data sharing beyond the original study scope, we have decided not to make IPD publicly available.

Publications

  • 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.

    PubMed 34784064

  • 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.

    PubMed 35838308

  • 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.

    PubMed 30598564

  • 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.

    PubMed 34417065

  • 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.

    PubMed 37787762

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

  • 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.

    PubMed 40757563

  • 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.

    PubMed 36597123

  • 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.

    PubMed 35802283

  • 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.

    PubMed 31563989

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

    PubMed 32452140

Questions about this trial

What is this clinical trial studying?

A study testing Homemade formula and Commercial formula in people with TBI Traumatic Brain Injury and Enteral Nutrition Therapy, run by Hospital General "Dr. Miguel Silva" de Morelia at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Femoral muscle (total femoral thickness, rectus femoris vastus intermedius) ultrasound (time frame: Change from baseline to end of study, an average of 10 days, with three measurements during follow-up (baseline, 5 days, and 10 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06949163, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.

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