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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Ketogenic feeding
BehavioralThe 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
BehavioralThe 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
Trial outcomes
Primary outcomes
Incidence of Adverse Events
Number of adverse events collected using a standardized adverse event reporting form (Unit: Count of events).
Adherence to the Intervention
Percentage of prescribed intervention sessions completed, assessed through adherence logs and system usage records (Unit: %)
Secondary outcomes
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).
Sponsors and contacts
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