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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ketogenic diet
Dietary supplementParticipants 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.
Low-fat Mixed diet
Dietary supplementParticipants 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Ketogenic DietExperimental treatment 1 intervention
Group B: Low-fat mixed DietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in maximal exercise performance
Participants will undergo VO2 max testing, conducted by trained professionals. VO2 max testing analyses will determine changes in maximal exercise performance
Time frame
baseline, 6 weeks, and end of the study (26 weeks)Secondary outcomes
1
Change in Cardiac Output (L/min) via cardiovascular magnetic resonance imaging (CMR) .
Changes in cardiac output will be assessed via Cardiovascular magnetic resonance imagining conducted by trained professionals. MRI imaging analyses will determine cardiac function. The images will be analyzed by trained imaging professionals to determine overall change (L/min).
Time frame
baseline, 6 weeks, and end of the study (26 weeks)2
Change Stroke Volume(mL) via cardiovascular magnetic resonance imaging (CMR)
Changes in stroke volume will be assessed via Cardiovascular magnetic resonance imagining conducted by trained professionals. MRI imaging analyses will determine cardiac function. The images will be analyzed by trained imaging professionals to determine change in stroke volume (mL).
Time frame
baseline, 6 weeks, and end of the study (26 weeks)3
Percent change in ejection fraction via cardiovascular magnetic resonance imaging (CMR)
Percent changes in ejection fraction will be assessed via Cardiovascular magnetic resonance imagining conducted by trained professionals. MRI imaging analyses will determine cardiac function. The images will be analyzed by trained imaging professionals to determine change in Ejection Fraction(%).
Time frame
baseline, 6 weeks, and end of the study (26 weeks)4
Change in New York Heart Association (NYHA) class
NYHA class will be determined by clinical examination by a qualified cardiovascular physician
Time frame
baseline, 6 weeks, and end of the study (26 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov