PneumoniaNCT07308483
Ketogenic Approach to Restore Muscle in Older Patients With Community-Acquired Pneumonia - KARMA-P Trial
A study testing Ketogenic feeding and Standard feeding in people with Pneumonia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to see if a ketogenic diet compared to a standard diet is better to maintain muscle function and health in hospital admitted pneumonia patients. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Pneumonia
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 31 Jul 2029
- Phase
- Interventional
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
- Bacterial community-acquired pneumonia
- Expected at least 10-day stay in the hospital
- Ability to ingest food orally
- Willingness to be randomized to either treatment group
- Willingness to participate in all study procedures
Who cannot join
- Failure to provide informed consent
- Moribund
- Vegetarian/vegan
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- 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
The purpose of the study is to see if a ketogenic diet compared to a standard diet is better to maintain muscle function and health in hospital admitted pneumonia patients.
Read the detailed description
Bacterial community-acquired pneumonia (CAP) is a leading cause of hospitalization and mortality in older adults, often resulting in significant muscle wasting, systemic inflammation, and microbiome dysbiosis. Muscle loss, driven by bedrest, acute illness, and antibiotic-induced dysbiosis, all contribute to prolonged hospital stay, delayed recovery, and long-term physical decline. Current interventions such as physical rehabilitation and increased protein intake are largely ineffective in mitigating the acute illness-induced muscle wasting due to metabolic dysfunction such as impaired glucose control. Preliminary evidence suggests that ketogenic enteral feeding is safe, reduces inflammation, stabilizes metabolism and preserves functional outcomes in hospitalized patients. Because most of older hospitalized CAP patients are able to ingest food orally, our study aims to test the safety, feasibility and determine effect sizes for preliminary evidence of a 10-day oral ketogenic diet (low carbohydrate, high fat) in older CAP patients.
The investigators will conduct a double-blinded pilot randomized clinical trial in 30 hospitalized older adults (>55 years) with bacterial CAP, randomizing participants to a ketogenic feeding (n=15) or standard hospital feeding (n=15). Muscle mass will be assessed using ultrasound, inflammatory and metabolic biomarkers from blood, and microbiome composition from oral and skin swabs collected at baseline, 10-Day post-intervention, and 1-month post-intervention follow-up. Handgrip strength will be collected at baseline and 10-day follow-up. Physical activity measures (accelerometry) will be measured for 7 days after the 10-day and 1-month follow-up visits. Physical function (short physical performance battery), handgrip strength, and activity levels (accelerometry) will be measured at 1-month follow-up. Daily blood ketone level measurements will guide feeding adjustments to maintain ketosis, and dietary habits will be assessed weekly post-intervention until 1-month follow-up. Meals for the 10-day intervention will be prepared in a metabolic kitchen by a clinical nutritionist.
If successful, this study will provide evidence for oral ketogenic feeding as an innovative intervention to prevent muscle wasting and functional decline, supporting a future phase IIb clinical trial targeting middle-aged and older adults hospitalized with CAP.
- Conditions
- Pneumonia
- Being tested
- Ketogenic feeding, Standard feeding
- Keywords
- ketogenic feeding, pneumonia
- Medical subject headings
- Pneumonia
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. No food group will be excluded in this diet prescription; however, the diet will emphasize low-glycemic sources of carbohydrate, and include mainly whole foods such as non-starchy vegetables with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements, if necessary. Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat will be limited to 10% of total fat intake. Patients will obtain the majority of their fat intake from poly- and mono-unsaturated fatty acids at a 4:1 ratio.
Standard feedingBehavioural
The standard, control diet will be compatible with the USDA guidelines. It will consist of approximately 60% carbohydrate, 20% protein, 20% fat. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide <2300 mg/day sodium. Saturated fat will be limited to 10% of total fat intake, and all dairy products will be fat-free (or low fat). Participants will obtain the majority of their fat intake from poly- and mono-unsaturated fatty acids at a 4:1 ratio matched to the ketogenic feeding group; however, total grams will be lower.
| Study group | Role | What they receive |
|---|---|---|
| ketogenic feeding | Active comparator | 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 standard, control diet will be compatible with the USDA guidelines. It will consist of approximately 60% carbohydrate, 20% protein, 20% fat. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. 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, at 10-day of feeding, and at 1 month follow-up
Adherence to the Intervention
Percentage of prescribed intervention sessions completed, assessed through adherence logs and system usage records (Unit: %)
Measured: From baseline to 1 month follow-up
Secondary outcomes (1)
Handgrip strength
Participants will be asked to squeeze a metal handle of a dynamometer device as hard as possible at 2 trials, which will be averaged (Unit: Kilograms).
Measured: At baseline, 10-Day post-intervention, and 1-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start30 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Robert T Mankowski, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308483
- Sponsor's protocol ID
- IRB-300015253
- Other IDs
- 1R21AG098466-01
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided