Ketogenic Diet vs Mixed Diet in Patients With Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOhio State University
About this trial
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 criteria
Qualifiers
Age ≥ 18 years old and ≤ 80 years old & willingness to be randomized to either diet.
NYHA class I - III for at least 3 months.
Ejection fraction ≥40% by biplane 2D, or 3D echo, or CMR
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Ketogenic diet
- Low-fat Mixed diet
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ohio State University
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov