Ketogenic Feeding for Muscle Preservation After Trauma
KETO TRAUMA
Ketogenic Feeding to Preserve Muscle Mass in Middle-aged and Older Trauma Injury Patients
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2026
CompletedFirst Posted
Study publicly available on registry
September 18, 2026
CompletedStudy Start
First participant enrolled
November 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
Study Completion
Last participant's last visit for all outcomes
August 31, 2029
September 18, 2026
September 1, 2026
2.1 years
September 14, 2026
September 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events
Number of adverse events collected using a standardized adverse event reporting form (Unit: Count of events).
At baseline and 10-day of feeding
Adherence to the Intervention
Percentage of prescribed intervention sessions completed, assessed through adherence logs and system usage records (Unit: %)
From baseline to 10 days follow-up.
Study Arms (2)
Ketogenic feeding
EXPERIMENTALThe ketogenic feeding will have a macronutrient composition of approximately 10% energy from carbohydrates, 25% energy from protein, and 65% energy from fat.
Standard feeding
PLACEBO COMPARATORThe participant will receive standard hospital care feeding.
Interventions
The ketogenic feeding will have a macronutrient composition of approximately 10% energy from carbohydrates, 25% energy from protein, and 65% energy from fat.
The participants will receive standard hospital care feeding.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 14, 2026
First Posted
September 18, 2026
Study Start (Estimated)
November 15, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
August 31, 2029
Last Updated
September 18, 2026
Record last verified: 2026-09