An interventional study of Homemade formula and Commercial formula in TBI Traumatic Brain Injury, Enteral Nutrition Therapy and Critical Illness, sponsored by Hospital General "Dr. Miguel Silva" de Morelia. Completed at 1 site in Mexico. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Hospital General "Dr. Miguel Silva" de Morelia · Not applicable, Interventional, and Other
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).
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).
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's enrollment of 39 is below the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Hospital General "Dr. Miguel Silva" de Morelia is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Elimination criteria:
Patients receiving homemade formula made with natural food and will be administered according to the study protocol
Other: Homemade formula
Patients receiving commercial formula and will be administered according to the study protocol.
Dietary Supplement: Commercial formula
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
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
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.
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)
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.
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)
Plan to share: 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.
Ran from Jun 2023 to primary completion in Mar 2025, 21 months.
Of 491 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's 21 months is below that.
Counting every sponsor, half of 515 studies reached it within 36 months; a quarter within 21 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital General "Dr. Miguel Silva" de Morelia