Traumatic Injury
Conditions
Keywords
ketogenic feeding, traumatic injury
Brief summary
The purpose of this study is to determine whether a ketogenic diet, provided as tube feeding, compared with a standard hospital tube feeding, is safe and feasible and helps preserve muscle mass and improve metabolic health in adults aged 55 years and older hospitalized with traumatic injury.
Interventions
BEHAVIORALKetogenic feeding
The ketogenic feeding will have a macronutrient composition of approximately 10% energy from carbohydrates, 25% energy from protein, and 65% energy from fat.
BEHAVIORALStandard feeding
The participants will receive standard hospital care feeding.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 55 years and older * Traumatic injury * Expected to survive and at least 10-day stay in the hospital * Expected to be enterally fed for at least 10 days * Willingness to be randomized to either treatment group * Willingness to participate in all study procedures
Exclusion criteria
* Failure to provide informed consent * Moribund * Vegeterian/vegan * Diagnosed dementia * Hip fracture, hip or knee replacement, or spinal surgery within past 4 months * Simultaneous participation in another intervention trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | At baseline and 10-day of feeding | Number of adverse events collected using a standardized adverse event reporting form (Unit: Count of events). |
| Adherence to the Intervention | From baseline to 10 days follow-up. | Percentage of prescribed intervention sessions completed, assessed through adherence logs and system usage records (Unit: %) |
Countries
United States
Outcome results
None listed