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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-26

Study Completion Date

2025-03-30

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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TBI Traumatic Brain Injury Enteral Nutrition Therapy Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Homemade formula

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

Group Type OTHER

Homemade formula

Intervention Type 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).

Commercial enteral formula

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

Group Type OTHER

Commercial formula

Intervention Type 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).

Interventions

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Homemade 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).

Intervention Type OTHER

Commercial 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).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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blenderized tube feeding polymeric formula

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No