Ketogenic Feeding for Muscle Preservation After Trauma
ConditionTraumatic Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Failure to provide informed consent
Moribund
Vegeterian/vegan
Diagnosed dementia
Trial design
Design model
Parallel
Treatments tested in this trial
Ketogenic feeding
BehavioralThe ketogenic feeding will have a macronutrient composition of approximately 10% energy from carbohydrates, 25% energy from protein, and 65% energy from fat.
Standard feeding
BehavioralThe participants will receive standard hospital care feeding.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Ketogenic feedingExperimental treatment 1 intervention
Group B: Standard feedingPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events
Number of adverse events collected using a standardized adverse event reporting form (Unit: Count of events).
Time frame
At baseline and 10-day of feeding2
Adherence to the Intervention
Percentage of prescribed intervention sessions completed, assessed through adherence logs and system usage records (Unit: %)
Time frame
From baseline to 10 days follow-up.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: