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

NCT07308483 | Not Yet Recruiting

• 2 other identifiers: IRB-3000152531R21AG098466-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia

Keywords

ketogenic feeding; pneumonia

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

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

  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: %)

  From baseline to 1 month follow-up

Secondary Outcomes (1)

• Handgrip strength

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

Study Arms (2)

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.

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.

Behavioral: Standard feeding

Interventions

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.

ketogenic feeding

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.

Standard feeding

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 29, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (1)