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
Ohio State University
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.
Description
Participants will be randomized to either a ketogenic diet (KD), or a low-fat diet (MD). Participants will eat the specified diet for a period of 6-months and be supported by dietary coaching. All foods and/or groceries will be provided at no cost for the first six weeks of the study. After the initial 6 weeks, and for the next 20-22 weeks, participants will change into a free-living diet period where food will not be supplied but they will receive educational materials and frequent coaching from a dietitian to help maintain the specified diet. Both diets are based on a slight reduction in d…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusions: 1. Age ≥ 18 years old and ≤ 80 years old \& willingness to be randomized to either diet. 2. NYHA class I - III for at least 3 months. 3. Ejection fraction ≥40% by biplane 2D, or 3D echo, or CMR 4. Echo findings of abnormal or indeterminant diastolic function or right heart catheterization (RHC) data: At rest: mean pulmonary capillary wedge pressure (PCWP) \> 15 mmHg. pulmonary vascular resistance (PVR) \< 3 Wood Units. 5. Stable medical therapy for at least 3 months as determined by the treating physician (no new cardiac or diabetic medications within 3 months of enrollment or dur…
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.
Location
- The Ross Heart HospitalColumbus, Ohio