Ketogenic Approach to Restore Muscle in Older Patients With Community-Acquired Pneumonia - KARMA-P Trial

ConditionPneumonia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 55 years and older

Bacterial community-acquired pneumonia

Expected at least 10-day stay in the hospital

Ability to ingest food orally

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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. 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 feeding

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ketogenic feedingActive comparator 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, at 10-day of feeding, and at 1 month follow-up
2

Adherence to the Intervention

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

Time frame
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).

Time frame
At baseline, 10-Day post-intervention, and 1-month post-intervention follow-up

Other outcomes

Sponsors and contacts

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