RecruitingNot ApplicableNCT06081543

Ketogenic Diet vs Mixed Diet in Patients With Heart Failure

A Prospective Randomized Unblinded Study of Ketogenetic Versus Mixed Diet on Exercise Tolerance in Subjects With the Metabolic Phenotype of Heart Failure With Preserved Ejection Fraction


Sponsor

Ohio State University

Enrollment

90 participants

Start Date

May 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to evaluate the effects of a low carbohydrate ketogenic diet (KD) versus a low-fat diet (MD) on exercise tolerance in participants with heart failure with normal pumping function and diabetes or pre-diabetes, or metabolic syndrome, or obesity.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares a ketogenic diet (very low carbohydrate, high fat) to a standard mixed diet in people with heart failure and preserved pumping function. Researchers want to know if reducing carbs and increasing fat intake can improve exercise capacity and heart function. **You may be eligible if...** - You are between 18 and 80 years old - You have heart failure with a pumping function of 40% or better - You have had stable heart failure symptoms for at least 3 months - You are overweight (BMI 25 or above), have Type 2 diabetes, prediabetes, or metabolic syndrome - You are able to do a treadmill exercise test - Your weight has been stable for the past 3 months **You may NOT be eligible if...** - You have Type 1 diabetes or a history of diabetic ketoacidosis - You have a pacemaker, defibrillator, or other implanted cardiac device - You are claustrophobic or have metal implants that prevent MRI - You have serious kidney disease (eGFR below 30) - You have had a heart attack or major cardiac procedure in the last 30 days - You are currently on a low-carb diet - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTKetogenic diet

Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff for the first 6 weeks. After that will be a free-living diet period where food will not be supplied but participants will receive educational materials and frequent coaching from a dietitian to help maintain the specified diet. Participants will be asked to exclusively follow the diet in efforts to control any dietary effects.

DIETARY_SUPPLEMENTLow-fat Mixed diet

Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff for the first 6 weeks. After that will be a free-living diet period where food will not be supplied but participants will receive educational materials and frequent coaching from a dietitian to help maintain the specified diet. Participants will be asked to exclusively follow the diet in efforts to control any dietary effects.


Locations(1)

The Ross Heart Hospital

Columbus, Ohio, United States

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NCT06081543


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