What side effects are associated with this type of intervention?

Common treatments for heart failure, such as ketogenic and low-fat diets, have specific side effects. Ketogenic diets can cause dehydration, electrolyte imbalances, constipation, and increased cholesterol levels. Low-fat diets may lead to gastrointestinal issues, nutrient deficiencies, and fluctuations in blood sugar levels. Both approaches require careful monitoring to manage these potential side effects effectively.

What prior FDA approvals exist?

FDA-approved treatments for heart failure typically include medications such as ACE inhibitors, beta-blockers, diuretics, and angiotensin II receptor blockers. These medications help manage symptoms and improve heart function. In addition to pharmacological treatments, lifestyle and dietary interventions are crucial. The trial comparing a Low Carbohydrate Ketogenic Diet (LCKD) and a Low-Fat Diet (LFD) aims to evaluate the impact of these diets on heart failure, focusing on metabolic improvements and exercise tolerance. While specific FDA approvals for dietary interventions in heart failure are not detailed, these approaches are part of comprehensive heart failure management strategies.

What other types of research exist?

Promising novel alternatives to the Low Carbohydrate Ketogenic Diet and Low-Fat Diet for heart failure patients include the Mediterranean Diet and the DASH (Dietary Approaches to Stop Hypertension) Diet. The Mediterranean Diet emphasizes the consumption of fruits, vegetables, whole grains, nuts, and olive oil, and has been shown to improve cardiovascular health. The DASH Diet focuses on reducing sodium intake and increasing the intake of potassium, calcium, and magnesium through fruits, vegetables, and low-fat dairy products, which can help manage blood pressure and improve heart function. Both diets are supported by clinical evidence for their benefits in cardiovascular health and may be considered as viable options for heart failure patients.

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Behavioural Intervention

Ketogenic Diet vs Mixed Diet for Heart Failure

Q: What is the mechanism of action of this treatment?

Common treatments for heart failure, such as the ketogenic diet and low-fat diet, work through different metabolic mechanisms. The ketogenic diet induces ketosis, promoting fat utilization over glucose, which may enhance cardiac energy efficiency and reduce harmful lipid accumulation in the heart. This can improve exercise tolerance and provide cardio-protective benefits. Conversely, a low-fat diet reduces fat intake and increases carbohydrate consumption, aiding in weight management and improving metabolic risk factors. These dietary interventions are crucial for heart failure patients as they target metabolic pathways to improve heart function and overall health.

N/A

Recruiting

Led By Yuchi Han, MD, MMSc

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old and ≤ 80 years old & willingness to be randomized to either diet

Be older than 18 years old

Must not have

History of diabetic ketoacidosis

Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, and end of the study (26 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing a ketogenic diet and a low-fat diet in people with heart failure and diabetes or related conditions. The goal is to see which diet improves exercise tolerance better. The ketogenic diet helps the body use fat for energy, while the low-fat diet focuses on reducing fat intake.

Who is the study for?

Adults aged 18-80 with heart failure, normal heart pumping function, and either diabetes, pre-diabetes, metabolic syndrome or obesity (BMI between 25-50) can join. They must have stable health for the past 3 months and be able to exercise on a treadmill. People with severe kidney disease, Type I diabetes, recent heart attacks or certain other serious health conditions cannot participate.

What is being tested?

The trial is testing how well two diets - a low carbohydrate ketogenic diet and a low-fat mixed diet - help people with heart failure improve their ability to exercise. Participants will be randomly assigned to one of these diets to see which is more effective.

What are the potential side effects?

Potential side effects from the ketogenic diet may include nutritional deficiencies, constipation or diarrhea due to high fat intake. The mixed diet could lead to unbalanced nutrition if not properly followed. Both diets require strict adherence that might affect lifestyle.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old and open to trying a new diet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had diabetic ketoacidosis in the past.

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I am not pregnant, breastfeeding, nor plan to become pregnant during the study.

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My kidney function is severely reduced.

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I have had or will have heart surgery within a month.

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I have had a heart transplant or am on the waiting list for one.

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I needed strong heart failure medication or mechanical support in the last week.

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I have not had, nor am I scheduled for, major surgery within 3 months.

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I have Type I diabetes.

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I need oxygen therapy for a lung condition.

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I have a specific heart condition like amyloidosis or muscular dystrophy affecting my heart.

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I have had severe low potassium levels below 3.0 mg/dL.

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I have ongoing irregular heartbeats.

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I have severe heart valve issues likely needing surgery soon.

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I have had heart rhythm problems that were not controlled or treated.

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I do not have heart conditions that could worsen my health unexpectedly.

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My liver tests are more than three times the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, and end of the study (26 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, and end of the study (26 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, and end of the study (26 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in maximal exercise performance

Secondary study objectives

B-natriuretic peptide (BNP)

Change Stroke Volume(mL) via cardiovascular magnetic resonance imaging (CMR)

Change in Cardiac Output (L/min) via cardiovascular magnetic resonance imaging (CMR) .

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low-fat mixed DietExperimental Treatment1 Intervention

This arm will be provided food consisting of \~25% fat, and the remaining calories from carbohydrate (\~55% after accounting for protein at \~20%).

Group II: Ketogenic DietExperimental Treatment1 Intervention

This arm will be provided food to induce a state of nutritional ketosis in each person as defined as blood Beta-hydroxybutyrate (3-OHB) ≥0.5 millimoles (mM), which will require most participants to consume \<50 g/day carbohydrate and 1.5g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketogenic diet

2020

Completed Early Phase 1

~720

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure, such as the ketogenic diet and low-fat diet, work through different metabolic mechanisms. The ketogenic diet induces ketosis, promoting fat utilization over glucose, which may enhance cardiac energy efficiency and reduce harmful lipid accumulation in the heart. This can improve exercise tolerance and provide cardio-protective benefits. Conversely, a low-fat diet reduces fat intake and increases carbohydrate consumption, aiding in weight management and improving metabolic risk factors. These dietary interventions are crucial for heart failure patients as they target metabolic pathways to improve heart function and overall health.

Successful treatment of severe cardiomyopathy in glycogen storage disease type III With D,L-3-hydroxybutyrate, ketogenic and high-protein diet.Low carbohydrate ketogenic diet enhances cardiac tolerance to global ischaemia.