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NCT Number: NCT07827820

Ketogenic Feeding for Muscle Preservation After Trauma

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.

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Key information

Conditions

Traumatic Injury Wounds and Injuries

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketogenic feeding

Behavioral

The ketogenic feeding will have a macronutrient composition of approximately 10% energy from carbohydrates, 25% energy from protein, and 65% energy from fat.

Standard feeding

Behavioral

The participants will receive standard hospital care feeding.

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: At baseline and 10-day of feeding

    Number of adverse events collected using a standardized adverse event reporting form (Unit: Count of events).

  2. Adherence to the Intervention

    Time frame: From baseline to 10 days follow-up.

    Percentage of prescribed intervention sessions completed, assessed through adherence logs and system usage records (Unit: %)

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Ketogenic Feeding to Preserve Muscle Mass in Middle-aged and Older Trauma Injury Patients

Acronym: KETO TRAUMA

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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