Traumatic InjuryKETO TRAUMANCT07827820
Ketogenic Feeding for Muscle Preservation After Trauma
A study testing Ketogenic feeding and Standard feeding in people with Traumatic Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Traumatic Injury
- What is being tested?
- Ketogenic feeding and Standard feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Robert Mankowski, PhD, 2059963006, rmankowski@uabmc.edu
About this study
Official title: Ketogenic Feeding to Preserve Muscle Mass in Middle-aged and Older Trauma Injury Patients
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.
- Conditions
- Traumatic Injury
- Being tested
- Ketogenic feeding, Standard feeding
- Keywords
- ketogenic feeding, traumatic injury
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic feedingBehavioural
The ketogenic feeding will have a macronutrient composition of approximately 10% energy from carbohydrates, 25% energy from protein, and 65% energy from fat.
Standard feedingBehavioural
The participants will receive standard hospital care feeding.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic feeding | Experimental | The ketogenic feeding will have a macronutrient composition of approximately 10% energy from carbohydrates, 25% energy from protein, and 65% energy from fat. Receives: Behavioral: Ketogenic feeding |
| Standard feeding | Placebo comparator | The participant will receive standard hospital care feeding. Receives: Behavioral: Standard feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Number of adverse events collected using a standardized adverse event reporting form (Unit: Count of events).
Measured: 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: %)
Measured: From baseline to 10 days follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert T Mankowski, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827820
- Sponsor's protocol ID
- IRB-300016623
- Other IDs
- UAB Team Science Grant Program
- Acronym
- KETO TRAUMA
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Feeding to Preserve Muscle Mass in Middle-aged and Older Trauma Injury Patients
- ClinicalTrials.gov ID
- NCT07827820
- Acronym / sponsor ID
- KETO TRAUMA / IRB-300016623
- Conditions
- Traumatic Injury
- Keywords
- ketogenic feeding, traumatic injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic feeding | Experimental | Behavioral: Ketogenic feedingThe 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 comparator | Behavioral: Standard feedingThe participant will receive standard hospital care feeding. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Failure to provide informed consent
- Moribund
- Vegeterian/vegan
- Diagnosed dementia
- Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic feedingThe ketogenic feeding will have a macronutrient composition of approximately 10% energy from carbohydrates, 25% energy from protein, and 65% energy from fat. | Behavioural | Ketogenic feeding |
| Standard feedingThe participants will receive standard hospital care feeding. | Behavioural | Standard feeding |
Primary outcome
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).
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: %)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic feeding and Standard feeding in people with Traumatic Injury, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: At baseline and 10-day of feeding). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.